All clinically suspicious mediastinal N, N, or N lymph nodes (> cm short-axis dimension on CT scan and/or positive on PET scan) confirmed negative for involvement with NSCLC by one of the following methods: mediastinoscopy, anterior mediastinotomy, endoscopic ultrasound (EUS)/endobronchial ultrasound (EBUS) guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy within days of randomization
Limited stage disease patients, with disease restricted to one hemithorax with regional lymph node metastases, including ipsilateral hilar, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular lymph nodes\r\n* Patients with disease involvement of the contralateral hilar or supraclavicular lymph nodes are not eligible\r\n* Patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not, are not eligible unless they have a negative thoracentesis\r\n* Patients with cytologically positive pleural or pericardial fluid, regardless of the appearance on plain x-ray, are not eligible
Patients with histologically positive axillary nodes post neoadjuvant therapy
Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal computed tomography [CT] or magnetic resonance [MR]), (but not by nodal sampling, or dissection) within days prior to registration \r\n* Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< . cm
Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins
Patients with evidence of disease outside of the pelvis, including presence of positive periaortic or inguino-femoral nodes
Metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes if not a candidate for surgery for these lesions.
Biopsy proven (from primary lesion and/or lymph nodes) diagnosis of cancer of the nasopharynx
Patients with clinical stage IA, IB or IIA squamous, adenosquamous, or adenocarcinoma of the cervix who have any/all of the following high-risk features after surgery:\r\n* Positive pelvic nodes\r\n* Positive parametrium\r\n* Positive para-aortic nodes- completely resected, PET/CT negative (PET only required if positive para-aortic nodes during surgery)
Locally advanced disease as determined by endoscopic ultrasound (EUS) stage >= primary tumor (T) and/or any T, lymph nodes (N)+ disease without metastatic disease (Mx)
Radiographic evidence of metastatic disease; patients with node-positive disease (=< positive nodes) at the time of radical prostatectomy are eligible; patients with pelvic nodes up to cm by short axis at the time of screening are eligible; patients with any enlarged lymph nodes in the retroperitoneum or above the aortic bifurcation or with pelvic nodes >= cm must be excluded
Patients with locally advanced BCC of the head and neck, consisting of at least one histologically or cytologically confirmed lesion >= mm in longest diameter that is considered to be inoperable or to have a medical contraindication to surgery, in the opinion of a Mohs dermatologic surgeon, head and neck surgeon, or plastic surgeon; locally advanced disease is considered to include involved lymph nodes of the neck; a patient with regionally involved lymph nodes in the neck is considered eligible; the patient should be considered a candidate for radiotherapy and should not have medical contraindications to receipt of radiation therapy\r\n* If a patient has distant metastatic spread of BCC (e.g., spread to distant areas outside the regional lymph nodes, clearly non contiguous areas of bone involvement, or distant metastasis to lung, brain, or other visceral organs), the patient should be considered as having distant metastasis and is not eligible\r\n* Note: all lesions that the investigator proposes to follow as target lesions during the course of the study must have previously been histologically confirmed as BCC\r\n* Acceptable contraindications to surgery include: \r\n** BCC that has recurred in the same location after two or more surgical procedures and successful curative resection is deemed unlikely \r\n** Complete surgical resection is not possible or is deemed excessively morbid (e.g. invasion into cranial nerves or skull base, proximity to brain, spinal canal, or orbit) \r\n** Anticipated substantial morbidity and/or major deformity from surgery (e.g. removal of a major facial structure, such as nose, ear, eyelid, eye, or jaw; or requirement for upper limb amputation) \r\n** Medical contraindication to surgery \r\n** Patient refusal of surgery due to anticipated morbidity \r\n** Other conditions considered to be contraindicating must be discussed with data coordinator before enrolling the patient
No pelvic lymph nodes > . cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
Subjects must have histologically or cytologically confirmed invasive breast cancer which meets the following criteria:\r\n* Estrogen receptor (ER) and progesterone receptor (PR)-negative as defined by local standard clinical immunohistochemistry (IHC) < %\r\n* HER-negative using local standard testing; negative is defined as IHC or + (if +, must reflex to ISH method); if ISH method is used, ratio < is considered negative\r\n* Clinical tumor size of at least . cm (T) by palpation or imaging, regardless of the ipsilateral regional lymph node status, or any tumor size but with ipsilateral regional lymph nodes involved by the tumor (any T if ipsilateral regional node positive); subjects with inflammatory breast cancer are eligible; if bilateral breast cancer is present, the subject is eligible if the contralateral tumor is ductal breast carcinoma in situ (DCIS) only (without any invasive disease on biopsy) or another invasive breast cancer of any size that is also ER, PR and HER negative\r\n* Any radiographic abnormal ipsilateral regional lymph nodes or any clinically concerning ipsilateral regional lymph nodes with the exception of internal mammary nodes, should be sampled with a percutaneous biopsy, but no sentinel axillary lymph node mapping/biopsy is allowed before chemotherapy; if clinically node negative (cNO) pre-chemotherapy ipsilateral sentinel axillary lymph node mapping/biopsy is not allowed
The primary tumor can be clinical stage T or T, if clinically node negative according to AJCC th Edition. If the regional lymph nodes are cN and cytologically or histologically positive or cN-N with or without a biopsy, the primary breast tumor can be clinically Tc, T, or T.
Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
Biopsy proven involvement of supraclavicular lymph nodes
Evidence of metastatic renal cell carcinoma on imaging and/or biopsy; involvement of regional lymph nodes is permitted
Pelvic lymph nodes > . cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
Enlarging lymph nodes > cm
INCLUSION - TREATMENT: No evidence of treatment related change in the lymph nodes on pathologic review
Disease Status: Patients must have progressive disease. Progression is based on iwCLL definition but excluding patients who have treatment related lymphocytosis as the sole progressive factor. Therefore, patients must have at least one of the following:\r\n* >= % increase in the products of at least two lymph nodes on two consecutive determinations two weeks apart (at least one lymph node must be >= cm); appearance of new palpable lymph nodes\r\n* >= % increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin; appearance of palpable hepatomegaly or splenomegaly, which was not previously present\r\n* Decrease in hemoglobin >= gm/dL, or decrease >= % in platelet or granulocyte count with a bone marrow biopsy showing CLL cell infiltrate\r\n* Progressive lymphocytosis, >= % higher than lowest absolute blood lymphocyte count (ALC) on single agent ibrutinib therapy, excluding ibrutinib treatment-related lymphocytosis\r\n* If receiving ibrutinib as part of a clinical trial: meets criteria for disease progression based on trial defined criteria
No evidence of metastases on imaging. This risk group does not require metastatic studies, but if performed they must be negative, or negative by composite review with an attending radiologist. Suspicious lymph nodes permissible if < mm
Therapy must be initiated within days of surgical resection of the sentinel lymph nodes and within months of initial diagnosis
Documented metastases of prostate cancer outside of the pelvis (pelvic lymph nodes are allowed)
Oligometastatic disease defined as disseminated metastases beyond regional lymph nodes that meet the following criteria:\r\n* No visceral metastases\r\n* Less than four bony metastases
Radiation oncologist does not plan to treat regional lymph nodes beyond standard whole breast tangent fields
Radiographic evidence of metastatic disease; patients with node-positive disease (? positive nodes) at the time of radical prostatectomy are eligible; patients with pelvic nodes less than . cm by short axis at the time of screening are eligible; patients with any enlarged lymph nodes in the retroperitoneum or above the aortic bifurcation or with pelvic nodes ? . cm must be excluded
Subjects who have been previously treated with definitive and/or adjuvant/salvage radiotherapy to the primary site and/or regional lymph nodes with concurrent ADT are allowed if the last hormone therapy delivered > months prior
Men with brain or visceral metastases (except regional lymph nodes) defined by CT or MRI imaging of the abdomen or pelvis
No lymph nodes larger than cm in the greatest dimension.
Patients with histological and/or cytological evidence of BPDCN in the peripheral blood, bone marrow, spleen, lymph nodes, skin, and/or other sites that is persistent/recurrent following prior treatment for BPDCN. Patients enrolled in the Expansion Phase of the Study:
Patients with histological and/or cytological evidence of BPDCN in the peripheral blood, bone marrow, spleen, lymph nodes, skin, and/or other sites that is either previously untreated or is persistent/recurrent following prior treatment for BPDCN. Eligibility criteria for UCART administration
The patient has three or less observable metastatic lesions. Metastatic lesions include distant M lymph node group; which will be counted as one site (M metastatic lymph nodes to include cervical, mediastinal, gastric, retroperitoneal lymph nodes will be counted as one lesion). Osseous metastases or visceral metastases will each count as one metastatic site. Each central nervous system (CNS) metastases will count as one metastatic site. Satellite lesions in the primary esophageal malignancy such as skipped esophageal primaries are not considered metastatic sites. Symptomatic metastatic sites can be treated locally prior to randomization or by palliative radiation
The patient must be clinically and radiographically node negative (N) to participate on this protocol; clinically suspicious regional nodes by imaging or physical exam require biopsy evaluation to exclude disease involvement
Incurable disease defined by the presence of metastases to other organs (stage IV) or disease beyond regional lymph nodes who have already received chemoradiation therapy, or have been assessed by Radiation Oncology consultation as not being candidates for chemoradiation therapy; dysphagia grade >= to tumor obstruction
Metastatic breast cancer (local spread to axillary or internal mammary lymph nodes is permitted)
For patients with left-sided tumors and enlarged nodes (> . cm in the shortest diameter) on the aortopulmonary window setting, the aortopulmonary nodes must be biopsied by extended mediastinoscopy, Chamberlain procedure, video-assisted thoracoscopic surgery (VATS) approach, or ultrasound-guided biopsy to ensure that the patient does not have N disease. At the time of cervical mediastinoscopy, esophageal endoscopic ultrasound-guided biopsy, or endobronchial ultrasound-guided biopsy, the following nodal stations must be examined and biopsied, if present:\r\n* Ipsilateral nodal station \r\n* Contralateral nodal station level , and \r\n* Subcarinal nodes (level )\r\nFor left-sided tumors, any lymph node in the superior or anterior mediastinum > . cm in the shortest axis on CT or positive on PET must be identified and biopsied. Eligibility requires that any PET-positive mediastinal or distant sites must be biopsy-negative.
(For Cohort B only): Presence of metastatic disease or prior radiation therapy of the primary breast carcinoma or axillary lymph nodes
Patients must have clinically or radiographically evident measureable disease at the primary site and/or nodal stations; patients may undergo a diagnostic tonsillectomy, and diagnostic lymph node excision (< nodes) is also allowable
Oligometastatic disease; in order to be eligible, the patient must have a total of < metastatic bone and/or metastatic lymph node sites based on bone and/or soft tissue lesions as defined by any of the following:\r\n* Bone metastases will be defined by bone imaging; if the patient has technetium bone scan, and/or F- sodium fluoride (NaF) PET performed, either study may be used for documenting metastases? both scans do not need to show the number of metastases required for study entry; for patients undergoing PSMA PET, only PSMA avid lesions that are consistent with metastasis will be counted as a site of metastasis\r\n* Distant metastatic lymph node disease; a lymph node >= cm in shortest dimension will be noted as involved with disease; distant metastatic lymph nodes will be determined as any lymph nodes outside the confines of the true pelvis; for patients undergoing PSMA PET, only PSMA avid lesions are consistent with metastasis will be counted as a site of metastasis\r\n* Any other soft tissue lesion deemed by the physician to be consistent with distant metastatic disease; for patients undergoing PSMA PET, only PSMA avid lesions that have a computed tomography (CT) or magnetic resonance imaging (MRI) correlate consistent with metastasis will be counted as a site of metastasis
Either clinically positive (N only) or clinically negative axillary nodes (N)
Distant metastasis that involves occurrence of breast cancer outside of locoregional breast and lymph nodes area.
Patient must have an initial nodal ultrasound that does not demonstrate more than four suspicious lymph nodes, any suspicious lymph nodes should be biopsied to determine if nodal metastatic disease present
Patient is participating in a NST protocol in which surgical excision of the breast and or lymph nodes are required
Histologically confirmed adenocarcinoma of the prostate (clinical stage TcTb, N, M) without involvement of lymph nodes, bone, or visceral organs
Patients have had prior radiotherapy for primary breast carcinoma or axillary lymph nodes
Incurable HPVOC, as defined by:\r\n* Relapsed or progressive disease at the primary site and/or regional lymph nodes after initial treatment (e.g. surgery, radiotherapy or chemoradiotherapy) with no potentially curative option (i.e. surgery or radiation); OR\r\n* Distant metastasis
Patients with matted lymph nodes, defined as three nodes abutting one another with loss of intervening fat plane that is a replaced with radiologic evidence of extracapsular spread
Tumor characteristics - any of the following are excluded:\r\n* Evidence of distant metastases\r\n* Tumors whose location is restricted to the tubular esophagus (i.e., without involvement of the GEJ or cardia)\r\n* Tumors whose proximal end are at the level of the carina or higher\r\n* Invasion of the tracheobronchial tree or presence of tracheoesophageal fistula\r\n* Palpable supraclavicular nodes, biopsy-proven involvement of supraclavicular nodes, or radiographically involved supraclavicular nodes (> . cm in greatest dimension)\r\n* TNM, TNany, or in situ carcinoma\r\n* Tumor must not extend or more cm into the stomach
More than histologically positive axillary lymph nodes or axillary lymph nodes with microscopic or macroscopic extracapsular extension
Positive non-axillary sentinel nodes or evidence of suspicious supraclavicular, infraclavicular, or internal mammary nodes by imaging or physical exam, unless biopsied and found to be negative for tumor
History or evidence of advanced urothelial carcinoma, including enlarged lymph nodes and/or distant metastases
Patients who are already MRD- (both in the blood and the bone marrow) after frontline therapy and have lymph nodes < . cm
Presence of an evaluable metastatic lesion (locoregional lymph nodes are acceptable)
Radiographically confirmed endometrial adenocarcinoma of stages III-IV requiring adjuvant therapy; if stage III disease is suspected, there should be multiple pelvic and/and or lymph nodes involved
Patients who had prior radiation therapy of the primary breast carcinoma or axillary lymph nodes
Prior radiation therapy of the primary breast carcinoma or axillary lymph nodes
Involvement of lymph nodes superior to the common iliac bifurcation, and/or outside the pelvis (distant lymph nodes). Lymph node involvement is defined by histopathological confirmation, or by a short axis measurement >mm on standard imaging (CT or MRI, but not PET).
Imaging studies can include but is not limited to the following: ultrasound, CT of pelvis and abdomen and magnetic resonance imaging (MRI) of pelvis/prostate and abdomen\r\n* The ultrasound, MRI or CT based volume estimation of the patients prostate gland should not be greater than grams (Repeat measurement after hormone downsizing allowed)\r\n* Clinically negative lymph nodes, within days of study enrollment, established by imaging (abdominal and pelvic CT or MRI) OR by nodal sampling OR by dissection; nodes > . cm should be biopsied; patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are < . cm in the short axis\t\r\n* MRI pelvis/prostate feasible for staging and planning\r\n* Patients with contraindications to MRI are not eligible
N patients are ineligible, as are those with pelvic lymph nodes >= cm in short axis diameter, defined as pathologically enlarged per Response Evaluation Criteria in Solid Tumors (RECIST) ., by CT or MRI of the abdomen and pelvis, unless the enlarged lymph nodes are negative after sampling
N-, N-, or N- pathologic axillary nodes
Patients may have radiographic evidence of metastasis in regional lymph nodes (N disease as defined by the National Comprehensive Cancer Network Prostate Cancer Guideline version .) at the discretion of the treating physicians, if regional lymph nodes can be included in the planned radiation field
Prostate cancer metastases to the bones, viscera, or non-regional lymph nodes (lymph nodes other than pelvic lymph nodes within the radiation treatment field)
Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< . cm
Cohort : Resected patients at high risk of recurrence; patients must meet at least one of the following criteria\r\n* Melanoma of mucosal origin\r\n* Desmoplastic/spindle cell melanoma\r\n* Primary melanoma of the head or neck with at least one of the following:\r\n** Macroscopic (clinically detectable or evidence on radiographic imaging) lymph node involvement\r\n** Nc or N# disease\r\n* Patients with non-head and neck primaries must have had preoperative/pathologic macroscopic lymph node involvement, defined by clinically evident on exam or imaging evaluation, plus at least one of the following by clinical, imaging, or pathologic evaluation:\r\n** >= cervical or axillary nodes\r\n** >= groin lymph nodes\r\n** Extracapsular extension (ECE) of tumor\r\n** Lymph nodes >= cm
Cohort : Neoadjuvant/definitive approach; patients must meet at least one of the following criteria\r\n* Melanoma of mucosal origin\r\n* Desmoplastic/spindle cell melanoma\r\n* Patients with radiographic evidence of tumor invasion into surrounding local structures rendering them inoperable\r\n* Head and neck melanomas with any macroscopic nodal involvement\r\n* Macroscopic nodal involvement; in addition, patients must also meet one of the following criteria\r\n** Recurrent nodal disease, with any number and size of nodes\r\n** >= cervical or axillary nodes\r\n** >= groin lymph nodes\r\n** Lymph nodes >= cm\r\n** ECE of tumor
Pathologic T-stage >= Ta and/or positive lymph nodes
Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histological confirmation that these nodes are negative for tumor
Prior surgical procedures that would alter the drainage patterns and would prevent us from identifying sentinel lymph nodes (SN)
The primary tumor and/or regional lymph nodes must be evaluable radiographically
Participants must have undergone simple, modified radical, or radical abdominal hysterectomy or vaginal hysterectomy and lymphadenectomy (pelvic nodes, para-aortic nodes, or both nodal basins) by open or laparoscopic assisted technique
Evidence of limited extrahepatic disease on preoperative radiological studies is acceptable if the life threatening component of disease is in the liver. Limited extrahepatic disease is defined in this protocol as follows: metastasis in bone, subcutaneous, lung or lymph nodes that is amenable to resection or radiation and has a defined treatment plan. Patients with extra-hepatic tumor burden which does not have a defined treatment plan (i.e. monitor or is unable to be resected or radiated) must not be included in the trial.
Clinically negative lymph nodes as established by imaging (pelvic +/- abdominal computed tomography [CT] or magnetic resonance imaging [MRI]), nodal sampling, or dissection, except as noted immediately below:\r\n* Patients with intermediate risk factors only do not require abdominopelvic imaging, but these studies may be obtained at the discretion of the treating physician\r\n* For men with any high risk feature (PSA > , Gleason score > , or clinical stage T), a pelvic CT or MRI, are required; it is recommended that the duration between these scans and study registration be less than days, but if the time period is > days and the opinion of the clinician is that repeat studies would offer limited benefit, then these studies do not need to be repeated; a lymph node will be considered radiographically positive if it is > . cm in size, occurs within the expected distribution for prostate cancer metastasis (i.e. internal iliac or obturator fossa), and is without classic benign features (i.e. fatty hilum); patients with lymph nodes equivocal or questionable by imaging are eligible for inclusion in this study
More than histologically positive axillary nodes
Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension
Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes at time of enrollment unless there is histologic confirmation that these nodes are negative for tumor
Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor
cN stage based on pelvic MRI. Any nodes ? mm in longest dimension are considered malignant, regardless of nodal morphology. For pelvic nodes < mm in longest dimension, if nodes are seen and are deemed to be morphologically benign in the opinion of the radiologist and surgeon, the patient is eligible. Patients with visible pelvic sidewall nodes are excluded
High-quality cross-sectional imaging by computerized tomography (CT) or magnetic resonant imaging (MRI) performed within weeks prior to enrollment and showed a resectable, but high-risk, intrahepatic cholangiocarcinoma (IHCCA) confined to the liver, bile duct, and /or regional lymph nodes. Tumors will be considered high-risk if the high-quality, contrast-enhanced CT and/or MRI +/- positron emission tomography (PET) scan showed:\r\n* T-stage >= Ib (Ib IV)\r\n* Solitary lesion > cm\r\n* Multifocal tumors or satellite lesions present confined to the same lobe of the liver as the dominant lesion but still technically resectable\r\n* Presence of major vascular invasion but still technically resectable\r\n* Suspicious or involved regional lymph nodes (N)\r\n* No distant extrahepatic disease (M)
More than positive axillary nodes on imaging or matted nodes on clinical exam
Measurable metastatic disease (by RECIST version [v] .) in the peritoneal cavity or retroperitoneal lymph nodes; disease outside of the peritoneal cavity is allowed as long as metastatic sites are also present within the peritoneum/retroperitoneum
Clinically positive axillary lymph nodes
Diagnosis of stage IB to III node-positive breast cancer; NOTE: Stages include: Ta-cNany, TxN, TxN\r\n* For patients with TN disease, ONE of the following criteria is strongly suggested, but not required:\r\n** Grade \r\n** =< years of age at time of screening for this study\r\n** Lymphovascular space invasion (LVSI) \r\n** or more lymph nodes positive\r\n** If only lymph node positive, measures mm or greater\r\n** Hormone-negative disease\r\n** Positive lymph nodes after chemotherapy\r\n** Extracapsular extension\r\n** Close or positive margin\r\nNOTE: Patients with evidence of infraclavicular (axillary level III), supraclavicular or internal mammary adenopathy on ultrasound or magnetic resonance imaging (MRI) imaging after diagnosis will be included ONLY if this disease can be included in the initial treatment field and supplemented with a Gy boost at the time of mastectomy flap boost
Patients with one or more positive lymph nodes as determined by radiographic assessment of MRI or computed tomography (CT)\r\n* NOTE: lymph nodes noted on MRI or CT to be > . cm on the short axis will require review by the local reference radiologist per institutional Response Evaluation Criteria in Solid Tumors (RECIST) review practices; if the lymph nodes are considered suspicious on repeat review, they must be confirmed negative for study participation
No clinically or pathologically involved lymph nodes on imaging
Patients must be randomized within days ( weeks) of surgical resection; if more than one surgical procedure is required to render the patient disease-free, the patient must be randomized within weeks of the last surgery\r\n* NOTE: patients with clinically positive lymph nodes for melanoma involvement or those with positive lymph nodes identified through lymphoscintigraphic and/or dye lymphographic techniques in the groin, axilla, or neck should have additional lymphadenectomy in those sites; the complete lymph node dissection procedure would be considered as the last surgery in counting the days unless a subsequent surgical procedure(s) was clinically required to ensure the disease free status
Presence of distant metastases documented clinically or radiographically with the exception of ipsilateral supraclavicular nodes
Radiographically matted nodes, defined as abutting nodes with loss of the intervening fat plane
Supraclavicular nodes, defined as nodes visualized on the same axial imaging slice as the clavicle
Clinical staging for the primary tumor can be cTc (must be . cm) or TT if clinically node negative; if the regional lymph nodes are cN and cytologically or histologically positive or if cNN with or without a biopsy, the primary breast tumor can be cTT
Patients with histologically confirmed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): International Federation of Gynecology and Obstetrics (FIGO) clinical stages IB/IIA with positive para-aortic lymph nodes or FIGO clinical stages IIB/IIIB/IVA with positive pelvic and/or para-aortic lymph nodes; nodal status will be confirmed by PET/CT scan, fine needle biopsy, extra peritoneal biopsy, laparoscopic biopsy or lymphadenectomy
Cervical cancer:\r\n* Patients with the following pathology findings may be treated with pelvic radiation with or without weekly cisplatin at the treating physicians discretion; the decision to add weekly cisplatin for these patients is at the treating physicians discretion\r\n** Patients with intermediate-risk features including two of the following histologic findings after radical hysterectomy:\r\n*** / or more stromal invasion\r\n*** Lymph-vascular space invasion\r\n*** Large clinical tumor diameter (> cm)\r\n** Patients with cervical cancer treated with a simple hysterectomy with negative margins\r\n* Patients with any of the following criteria following radical hysterectomy are eligible for this study and must receive weekly cisplatin:\r\n** Positive resected pelvic nodes and para-aortic nodes negative if removed: Note: if para-aortic nodes are not removed, CT abdomen or PET CT must demonstrate no evidence of lymphadenopathy\r\n** Microscopic parametrial invasion with negative margins
Measurable disease as determined by contrast-enhanced CT scan with primary lung tumor distinct from mediastinal lymph nodes
Positive ipsilateral mediastinal node or nodes (N) with or without positive ipsilateral hilar nodes (N); N nodes must be separate from primary tumor by either CT scan or surgical exploration and the maximum nodal diameter of involved N nodes cannot exceed . cm; N status must be pathologically confirmed to be positive within weeks prior to registration by one of the following:\r\n* Mediastinoscopy\r\n* Mediastinotomy (Chamberlain procedure)\r\n* Transesophageal needle biopsy using endoscopic ultrasound (EUS-TBNA)\r\n* Endobronchial ultrasound biopsy using endoscopic ultrasound guidance (EBUS-TBNA)\r\n* Thoracotomy\r\n* Video-assisted thoracoscopy\r\n* Transbronchial needle biopsy by Wang technique (TBNA)\r\n* Fine needle aspiration under CT guidance\r\nNote: Demonstration of N status DOES NOT require sampling of all potentially positive nodes; it is adequate to document any N node as positive at the time of registration; for left sided lesions, the following nodal levels should be biopsied: L, L, R, R and or stations and whenever possible to rule out microscopically involved lymph nodes; for right sided lesions levels R, R, L, L and should be sampled whenever possible to rule out microscopically involved lymph nodes; investigators are strongly encouraged to biopsy multiple stations of mediastinal lymph nodes at the time of invasive staging in addition to those nodes that are abnormal on PET/CT or CT scan; PET/CT positivity in the ipsilateral mediastinal lymph nodes will not be sufficient to establish N nodal status; ipsilateral mediastinal lymph nodes associated with right sided tumors must be biopsied; the mediastinal nodal biopsy or aspiration can only be omitted in the special circumstance in which ALL of the following are true:\r\n* The tumor is left sided\r\n* Paralyzed left true vocal cord documented by bronchoscopy or indirect laryngoscopy; note: bronchoscopy is not required but is at the discretion of the patients surgeon; it is recommended in patients who have central tumors or disease near the carina or in another position that may impact resectability, or to document paralyzed recurrent laryngeal nerve, in cases of aortopulmonary (AP) nodal involvement\r\n* Nodes visible in the AP (level ) region on CT scan\r\n* Distinct primary tumor separate from the nodes is visible on CT scan\r\n* Histologic (biopsy) or cytologic (needle aspiration or sputum) proof of non-small cell histology from the primary tumor\r\nRegardless of method of documentation of N disease, the following must be documented:\r\n* From the Operative and Pathology reports, all mediastinal nodes shown to be both positive and negative (including contralateral nodes) must be designated on the I form according to the Lymph Node Map\r\n* If the procedures to document N eligibility were done at a non-member facility, the patient is still eligible if the institution principal investigator (PI) reviews the outside pathology slides and report with the institution's pathologist in conjunction with the outside operative report, and generates a report that verifies the original diagnosis and lymph node mapping, as consistent with the staging requirements of the protocol
Measurable liver confined disease with bi-dimensional measurements, required within weeks of screening; lesions reported on imaging as too small to characterize, abdominal lymph nodes < . cm or ascites in the setting of cirrhosis are not considered metastatic disease unless cytology proven
Patient who received adjuvant chemotherapy and have AJCC th edition Prognostic Stage Group III tumor; or patient who received neoadjuvant chemotherapy and have or more ipsilateral axillary lymph nodes with residual tumor metastases greater than . mm in lymph node(-s) and residual tumor greater than . mm in breast tissue
Distant metastases of breast cancer beyond regional lymph nodes
Has histological and/or cytological evidence of BPDCN in the peripheral blood, bone marrow, spleen, lymph nodes, skin, and/or other sites that is either previously untreated or is persistent/recurrent following prior treatment for BPDCN.
Has histological and/or cytological evidence of BPDCN in the peripheral blood, bone marrow, spleen, lymph nodes, skin, and/or other sites that is either previously untreated or is persistent/recurrent following prior treatment for BPDCN.
Presence of clinically apparent or suspected metastasis to sites other than lymph nodes or peritoneal surfaces
confirmed extra-hepatic metastases. Limited indeterminate extra-hepatic lesions in the lung and/or lymph nodes are permitted (up to lesions in the lung, with each individual lesion < cm; any number of lymph nodes with each individual nodes <. cm)
Evidence of bone, brain, visceral or soft tissue metastasis, including lymph nodes on pelvic computed tomography (CT) (>= cm in longest diameter)
Patients must have tumors determined to be easily accessible for biopsy (e.g. pleural-based lesions, peripheral lymph nodes, soft tissue metastases, large liver metastases, etc)
Lymph nodes as only sites of metastases
Confirmed presence of extra-hepatic disease except lung nodules and mesenteric or portal lymph nodes ? . cm each
No clinical evidence of regional lymph node metastasis\r\n* Computed tomography (CT) (with contrast if renal function is acceptable; a noncontrast CT is permitted if the patient is not a candidate for contrast), magnetic resonance imaging (MRI), nodal sampling, or dissection of the pelvis within days prior to step registration\r\n* Patients with pelvic lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< cm in the short axis
Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies
Patients must have no evidence of metastatic disease or clinically enlarged lymph nodes on computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen and pelvis and CT chest obtained within days of registration (a negative biopsy is required for lymph nodes >= cm in size to confirm lack of involvement); patients with lymph nodes >= cm in whom a biopsy is deemed not feasible are not eligible; patients with elevated alkaline phosphatase or suspicious bone pain should also undergo baseline bone scans to evaluate for bone metastasis
Mediastinoscopy or endobronchial ultrasound (EBUS) guided biopsy of mediastinal lymph nodes is required for all patients; must be done within weeks of study entry
Invasive mediastinal staging - all patients with CT and/or PET evidence of hilar (level ) or mediastinal lymph nodes > . cm in the shortest diameter must be staged by either cervical mediastinoscopy, esophageal endoscopic ultrasound guided biopsy, or endobronchial ultrasound guided biopsy
One to involved lymph nodes identified at axillary staging
More than involved nodes identified at axillary staging
Participants who have undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
Histologically confirmed positive axillary nodes in the ipsilateral axilla; palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor
Persons with positive sentinel nodes must have a complete lymphadenectomy
Any \clinical\ T tumor as defined by primary tumor/regional lymph nodes/distant metastasis (TNM), including inflammatory breast cancer
Residual carcinoma in one or more regional lymph nodes that would meet AJCC th edition criteria for N - N disease.
Clinically negative lymph nodes as established by imaging (pelvic +/- abdominal computed tomography [CT] scan or magnetic resonance imaging [MRI]), nodal sampling, or dissection within days prior to registration, except as noted immediately below: \r\n* Patients with a single intermediate risk factor only do not require abdominopelvic imaging, but these studies may be obtained at the discretion of the treating physician; patients with or risk factors are required to undergo pelvic +/- abdominal CT or MRI\r\n* Patients with lymph nodes equivocal or questionable by imaging are eligible without biopsy if the nodes are =< . cm; any node larger than this on imaging will require negative biopsy for eligibility
Patients with hilar or mediastinal lymph nodes =< cm and no abnormal hilar or mediastinal uptake on positron emission tomography (PET) will be considered N; patients with > cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may be eligible if directed tissue biopsy of all abnormal identified areas are negative for cancer
Patients with histologically proven prostate cancer treated with surgery, radiation, or the combination of surgery and radiation for prostate cancer (metastatic to regional lymph nodes) with resection of the nodes, who now has a rising PSA value after definitive local therapy, and no visible metastatic disease on conventional imaging studies
Patients to be included are those with measurable, localized amyloid deposits (larynx, subcutaneous tissue, muscle, lung, lymph nodes, etc) or clinically evident systemic disease (liver, kidney, heart, etc)
Patients with metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes will not be eligible
COHORT A: History or presence of distant metastatic lymph node(s) (e.g., retroperitoneal or non-regional pelvic lymph nodes) are allowed
Localized disease. The malignancy is confined to one affected hemithorax. Mediastinal N lymph nodes via cervical mediastinoscopy or EBUS (endobronchial ultrasound) must be negative in order to be eligible
Post-mastectomy radiotherapy is required for all participants with a primary tumor ? cm or involvement of ? lymph nodes. For participants with primary tumors < cm or with < involved lymph nodes, provision of post-mastectomy radiotherapy is at the discretion of the treating physician. Study registration must occur within days of completion of radiation.
Primary tumor =< cm and - positive axillary lymph nodes (T-, N-, M)
Residual disease in the breast or lymph nodes at the time of definitive surgical treatment.
For lymph nodes to be considered measurable (i.e., target or evaluable lesions), they must be >= mm in at least one dimension, using spiral CT
Nodal status: Involvement of lymph nodes beyond the field of resection should be considered unresectable due to distant spread and therefore not eligible for this protocol.
No clinical evidence of metastatic prostate cancer, or enlarged pelvic lymph nodes in the imaging studies
Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as specified in protocol
Pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy
Involved pelvic or para-aortic lymph nodes by imaging or pathology
Subjects with or without palpable lymph nodes
Women with fludeoxyglucose F- (FDG)-positron emission tomography (PET) positive or indeterminate pelvic lymph nodes and negative paraaortic nodes
Patients with pc-ALCL that has spread systemically (e.g., to lymph nodes, bone marrow, or visceral organs) may be included so long as pc-ALCL was the primary diagnosis for at least months before systemic involvement was confirmed; MF patients must be stage IB or greater
Participants must have histologically confirmed invasive breast cancer confined to the breast and regional lymphatics (supraclavicular, axillary, internal mammary lymph nodes)
Locally advanced or metastatic Her/Neu positive breast cancer (defined as immunohistochemistry [IHC] + or a fluorescence in situ hybridization [FISH] ratio of >= .); this may be on either a primary tumor or a metastatic site, and there is no time limit from the time the specimen was obtained; locally advanced breast cancer (LABC) includes breast cancers with advanced primary tumors, i.e., large diameter (at least cm) or those with skin and/or chest wall involvement, and advanced regional lymph node involvement; it also includes a rare subgroup, inflammatory breast cancer; in the American Joint Committee on Cancer and the International Union for Cancer Control (AJCC-UICC) TNM breast cancer staging system, locally advanced breast cancer (LABC) includes patients with stage III disease; this comprises:\r\n* Advanced primary tumors (tumors > cm in greatest dimension [T]; direct extension to the chest wall and/or to the skin [T]: ulceration, skin nodules, and/or edema (including peau d'orange) confined to the same breast, inflammatory breast cancer [IBC, Td])\r\n* Advanced regional lymph nodes (ipsilateral level I, II axillary lymph nodes that are clinically fixed or matted or clinically detected internal mammary lymph nodes in the absence of axillary lymph node metastases [N], ipsilateral infraclavicular [level III axillary] lymph nodes, ipsilateral internal mammary lymph node[s] with axillary lymph nodes, or ipsilateral supraclavicular lymph nodes [N])
Sites of metastatic disease to be treated on protocol are limited to bone, spine, soft-tissue, and lymph nodes only
Patients with newly diagnosed stage IV NSCLC with an untreated primary must have no more than active extracranial metastatic lesions other than the primary site and regional lymph nodes\r\n* Patients with metastatic disease treated by local therapy at the time of registration but untreated thoracic disease will be included
Cumulative diameter of lung lesions must be =< cm (excluding lymph nodes)
Patients must not have any palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor
or more axillary lymph nodes involved with cancer
Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT
Histologic involvement of or more regional lymph nodes
Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes > cm; or histologically positive lymph nodes
Pre-treatment clinical stage of primary tumor (T)- lymph nodes (N) any metastasis (M) or T any N positive M as determined by laparoscopy, CT scan (or PET/CT), or endoscopic ultrasound (histologic confirmation of lymph involvement is not required); therefore, patients can have measurable or non-measurable disease\r\n* Patients with T-NM tumors or patients with metastatic disease are NOT eligible
Any of the following as the only site(s) of disease: palpable lymph nodes not visible on imaging studies, skin lesions, or bone marrow involvement only
Nodal status: Involvement of lymph nodes beyond the field of resection should be considered unresectable due to distant spread and therefore not eligible for this protocol.
Patients must have histologically or cytologically confirmed localized (TN-M or T-NanyM, stage IB-III) Siewert type or type esophageal adenocarcinoma that is amenable to surgical resection as determined by a thoracic surgeon and for which all disease (primary tumor and involved lymph nodes) can be treated with radiation, as determined by a radiation oncologist
Extrahepatic metastases or malignant nodes beyond the periportal region; celiac, pancreaticoduodenal and para-aortic nodes > cm are ineligible; note that benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is > . cm
Axillary lymph nodes negative by pre-operative physical examination in all cases and pathologic examination from surgery for invasive disease
Clinically or pathologically positive axillary lymph nodes
Patients with confirmed unresectable Stage IIB or Stage III non-small cell lung cancer of any histologic-subtype appropriate for definitive concurrent chemotherapy and radiation as determined by multi-disciplinary assessment; all detectable tumor should be encompassable by radiation therapy fields, including both the primary tumor and the involved regional lymph nodes
Patients with stage II disease and clinical suspicion for metastatic disease based on reported symptoms, physical examination findings, or laboratory abnormalities must have staging studies demonstrating no evidence of metastatic disease (with exception of axillary lymph nodes or mammary nodes); patients with stage III disease must have staging studies demonstrating no evidence of metastatic disease (with exception of axillary lymph nodes or mammary nodes), even if asymptomatic with normal physical examination and laboratory values; such staging studies must include: chest imaging (chest x-ray, computed tomography [CT], or MRI), abdominal/pelvis imaging (CT or MRI), and bone imaging (bone scan or positron emission tomography [PET]-scan); abnormalities that are indeterminate and too small to biopsy should be followed with further imaging, as appropriate, but do not exclude patients from the study; abnormalities that are suspicious and large enough to biopsy exclude patients from the study, unless a biopsy is performed and is negative for metastatic disease
Definitive evidence of metastatic disease with exception of axillary lymph nodes or mammary nodes
Presence of at least ONE single accessible AND palpable lymph node in the cervical, supraclavicular, axillary, inguinal, or femoral regions; the size of the lymph nodes must be larger than x cm in the horizontal and perpendicular axes
Presence of at least ONE single accessible AND palpable lymph node in the cervical, supraclavicular, axillary, inguinal, or femoral regions; the size of the lymph nodes must be larger than x cm in the horizontal and perpendicular axes
Palpable lymph nodes > cm in maximal dimension
Metastatic breast cancer (local spread to axillary lymph nodes is permitted).
Histologically or cytologically confirmed diagnosis of extensive-stage small-cell lung cancer (ES-SCLC) with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version .; ES-SCLC is defined as: small-cell lung cancer (SCLC) that has spread beyond one hemithorax and regional lymph nodes on the same side (e.g., supraclavicular) to the contralateral hemithorax, lymph nodes, or more distant locations in the body
Patients with bulky lymph nodes (LNs) (? cm) or marked splenomegaly (i.e. extending into pelvis or crossing the midline).
Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection
Direct evidence of hilar or mediastinal lymph nodes or distant metastases after appropriate staging studies
Patients with extrahepatic disease or whose HCC involves the local vasculature, regional lymph nodes or distant metastatic sites
Distant metastases of breast cancer beyond regional lymph nodes
Radiation oncologist is planning to treat regional lymph nodes including internal mammary nodes and meet acceptable protocol dosimetric requirements
Patients with evidence of metastatic disease, including:\r\n* Positive malignant cytology of the pleural, pericardium or peritoneum\r\n* Radiographic evidence of distant organ involvement\r\n* Non-regional lymph nodes that cannot be contained within a radiation field
Extensive extrahepatic tumor (not just confined to lymph nodes/bone metastases)
Histological proof of muscle-invasive transitional cell carcinoma of the bladder (stage II-III). Subjects with evidence of metastatic nodal disease to the obuturator or presacral lymph nodes only may be included (N M). Subjects with any degree of fixation of the pelvic sidewall are not eligible.
Patients with involved lymph nodes are candidates for the study as long as regional nodal radiation is not required by the treating physician
If PMRT is recommended, the treatment fields will include the axillary, supraclavicular, and internal mammary nodes
The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
Current or prior metastases beyond regional lymph nodes
Completed neoadjuvant therapy with an approved regimen that includes trastuzumab and at least four cycles ( weeks) of taxane-containing chemotherapy and underwent surgery with final pathology showing evidence of residual disease in the breast or axilla (residual ductal carcinoma in situ or microinvasive disease not eligible) or underwent surgery as a first intervention and was found to be pathologically node-positive: ? positive lymph nodes (pN or pN) regardless of hormone receptor status or - positive lymph nodes (pN) if hormone receptor negative. Patients with micrometastases (pNmi) are not eligible.
Completed or receiving appropriate radiation therapy if indicated: For patients undergoing total mastectomy surgery as a first intervention, post-mastectomy radiation to the chest wall, infraclavicular and supraclavicular areas is required for patients with ? positive lymph nodes. Radiation to the internal mammary lymph nodes is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist. For patients with - positive lymph nodes, post-mastectomy radiation to the chest wall, infraclavicular, supraclavicular, and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist.
For patients undergoing breast conserving surgery (BCS) as a first intervention, whole breast irradiation with or without a boost, and radiation to the infraclavicular and supraclavicular areas is required for patients with ? positive lymph nodes. Radiation to the internal mammary lymph nodes is not required but is allowed at the discretion of the patient's treating radiation oncologist. For patients with - positive lymph nodes, whole breast irradiation with or without a boost is required. Radiation to the infraclavicular, supraclavicular, and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating medical oncologist.
For patient's undergoing mastectomy after neoadjuvant chemotherapy post-mastectomy radiation to the chest wall, infraclavicular and supraclavicular areas is required for patients presenting with clinical N or N disease or with ? positive lymph nodes identified pathologically at the time of surgery. Radiation to the internal mammary lymph nodes is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist. For patients with - positive lymph nodes identified pathologically, post-mastectomy radiation to the chest wall, infraclavicular, supraclavicular and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist.
For patient's undergoing BCS after neoadjuvant chemotherapy, whole breast irradiation with or without a boost is required. For patients with clinical N or N disease or with ? positive lymph nodes identified pathologically at the time of surgery, radiation to the infraclavicular and supraclavicular areas is required. Radiation to the internal mammary lymph nodes is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist. For patients with - positive lymph nodes identified pathologically, radiation to the infraclavicular, supraclavicular and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist.
Participants undergoing preoperative systemic therapy must have residual invasive disease in the breast or axillary lymph nodes at the time of definitive surgery
Patients with persistent palpable axillary nodes after NAC, as assessed by physical exam
The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes (i.e., all patients should be any T, N, M)
Staging at the time of enrollment indicates NO/N (does not involve lymph nodes or includes involvement in nodes within ipsilateral hilum),
Have histologic or cytologic biopsy-proven diagnosis of unresectable stage III or distant metastatic melanoma, irrespective of histologic type (i.e. cutaneous, unknown primary, mucosal, or ocular); patients with resectable bulky stage IIIB or stage IIIC melanoma (for example at least .-cm in shortest diameter for lymph nodes infiltrated by tumor and at least -cm in longest diameter for non-lymph nodes infiltrated by tumor) can also be entered into the study at the discretion of the principal investigator
For patients with metastatic renal tumors to be enrolled, a histologic diagnosis of renal cell carcinoma must exist and any burden of disease >= cm by CT or MRI is acceptable; the metastatic sites may be kidney, intra-abdominal (such as liver), brain, bone, or lymph nodes; lung lesions are NOT eligible because of the motion artifact caused by respiration
Patients with more than sites of extrahepatic disease (including nodes and pulmonary nodules)
Evidence of distant disease outside of regional lymph nodes
Patient must have a negative (normal) axillary ultrasound performed at Siteman Cancer Center; lymph nodes will be evaluated based on morphologic features; axillary ultrasound (AUS) will be considered positive (abnormal) if lymph nodes are noted to be completely hypoechoic (absent hilum) or to have focal hypoechoic cortical thickening/lobulation greater than mm
Indication for EBUS-guided needle biopsy based on suspicion of either benign or malignant disease in mediastinal or hilar lymph nodes
Willing to undergo biopsy of a metastatic lesion (in patients with reasonably accessible metastatic lesions such as chest wall, skin, subcutaneous tissue, lymph nodes, bones, peripheral lung, and liver metastases)
Measurable nodes on the recent cross sectional imaging (computed tomography [CT], MRI, ultrasound [US]) or suspicious lymph nodes for metastasis
Patients who have had their primary site tumor removed by surgery but still present with grossly enlarged lymph nodes are eligible for this study
Patients that underwent previous surgical resection for the same disease (except for biopsy or surgery removing primary site tumor but still present with grossly enlarged lymph nodes)
Patients with hilar or mediastinal lymph nodes < cm and no abnormal hilar or mediastinal uptake on PET will be considered N; patients with > cm hilar or mediastinal lymph nodes on CT or abnormal PET/CT (including suspicious but non-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer
The subject has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes.
No abnormal axillary nodes identified on grayscale axillary ultrasound (AUS), or abnormal nodes with benign subsequent FNA biopsy
Lymphnode negative and a clinical tumor classification of T (?.cm)-T or with - positive lymph nodes and a clinical tumor classification of T-T DCIS or LCIS are allowed in addition to invasive cancer at T or T level.
Patients must have progressive disease on single agent ibrutinib therapy (but not within the first months of initiating ibrutinib therapy); progression is based on iwCLL definition, but excluding patients who have treatment-related lymphocytosis as the sole progressive factor; therefore, patients must have at least one of the following:\r\n* >= % increase in the products of at least two lymph nodes on two consecutive determinations two weeks apart (at least one lymph node must be >= cm); appearance of new palpable lymph nodes\r\n* >= % increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin; appearance of palpable hepatomegaly or splenomegaly, which was not previously present\r\n* Decrease in hemoglobin >= gm/dL, or decrease >= % in platelet or granulocyte count with a bone marrow biopsy showing CLL cell infiltrate\r\n* Progressive lymphocytosis, >= % higher than lowest absolute lymphocyte count (ALC) on single agent ibrutinib therapy, excluding ibrutinib treatment-related lymphocytosis\r\n* If receiving ibrutinib as part of a clinical trial: meets criteria for disease progression based on trial defined criteria