Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor
Eligible for CHOP regimen
At least 1 prior chemotherapy regimen
All participants must be prescribed combination antiretroviral therapy with the goal of virological suppression using an acceptable regimen that adheres to national guidelines for treatment of HIV infection; non-suppressed, treatment experienced patients, defined as patients with a viral load > 400 copies/mL who have been on antiretroviral therapy for more than 4 months can be enrolled if an alternative antiretroviral therapy (ART) regimen is available that includes at least two ART drugs that, in the opinion of the site investigator, are expected to have activity based on genotypic testing (if available) and treatment history; patients are not allowed to receive zidovudine (azidothymidine [AZT]) as part of concurrent chemotherapy and ART regimen, since it is myelosuppressive; zidovudine may be discontinued and substituted as clinically indicated prior to or at the time of enrollment
Patients may not have progressed on more than two chemotherapy regimens in the metastatic setting; the following will NOT be counted as a prior line of cytotoxic chemotherapy:\r\n* If a patient discontinued a cytotoxic regimen due to toxicity (e.g., hypersensitivity or neuropathy) but had not progressed on that regimen, or if a prior chemotherapy regimen was discontinued after response achieved, it will not be counted in the number of prior chemotherapy regimens allowed\r\n* Prior hormonal therapy and non-hormonal targeted therapy; including the combination of an aromatase inhibitor and everolimus\r\n* Targeted and biologic therapies\r\n* The patient can receive a stable dose of bisphosphonates or denosumab for bone metastases, before and during the study as long as this was started at least 5 days prior to study treatment
Patients with histologically confirmed advanced solid tumors (regimen A) or breast or pancreas (regimen B)
Patients who have already started or received post-transplant maintenance or consolidation regimen
a) Active Disease (1) Clinically suspected or documented relapse/progression, in first or second relapse following at least one cycle of an asparaginase-based chemotherapy regimen OR (2) Initial disease or first or second relapse and unable to tolerate one full cycle of asparaginase-based chemotherapy regimen OR b) High-risk disease (stage III/IV, KPI groups 3-4 or IPI intermediate-high) prior to second CR regardless of previous chemotherapy.
Patients must have failed a carboplatin-based regimen
Patients with exocrine pancreatic adenocarcinoma must have predominant adenocarcinoma histology. Patients must have received prior therapy with a gemcitabine-based or 5FU-based regimen, if eligible, and should have received no more than 1 systemic regimen in the unresectable or metastatic setting.
Ability to be off prednisone and other immunosuppressive drugs for at least 3 days prior to the NK cell infusion (excluding preparative regimen pre-meds)
Part 2, Cohort 2, Must have received ? 1 prior treatment regimen for ovarian cancer, at least 1 of which is a platinum-based regimen
Patients may have received 0-1 prior chemotherapeutic regimen for metastatic breast cancer and must have been off treatment with chemotherapy for at least 21 days before enrollment in the study; the number of patients with 0 prior chemotherapeutic regimen will be limited to a maximum of n = 20
Patients must have received at least one cycle of the cytotoxic chemotherapy regimens (or regimen of similar intensity) listed in Appendix D within 3 months of enrollment (measured from the start date of chemotherapy) OR have had an autologous transplant within 24 months of enrollment OR receive 300 cGy as part of the preparative regimen
Must have previously received and progressed on at least 1 prior chemotherapy regimen.
Prior regimen within 6 months
The patient should have received all established therapies where there is a clear, superior available regimen available for the patient and the patient should have demonstrated progressive disease on or since completion of the last treatment regimen
Prior regimen must be within 6 months of registration
Patients may be treatment-naive or have failed previous regimen of intravesical therapy
Prior therapy:\r\n* Patients may have received unlimited prior treatment for the dose escalation part\r\n* For the expansion cohort patients must have ? 4 prior lines of chemotherapy\r\n* Hormonal therapy does not count towards total lines of therapy\r\n* Maintenance therapy is considered part of the preceding regimen if one or more of the same drugs are continued\r\n* Neoadjuvant and adjuvant chemotherapy are considered one regimen if they are a continuation of the same regimen with interval debulking surgery
Patients may not have received more than 3 prior regimens, where the regimen intent was to induce remission
Subjects must have relapsed or refractory non-Hodgkin lymphoma treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve partial or complete remission with the last regimen.
No limit to the number of prior chemotherapy or endocrine therapy regimens received; use of a previous fluoropyrimidine-containing regimen in advanced/metastatic setting is permitted as long as the subject discontinued the regimen for reasons other than progression
Patient has used capecitabine in a past regimen for metastatic disease
For Dose Escalation, NSCLC and Ovarian Expansion Cohorts: Subject must have failed at least one prior chemotherapy regimen for metastatic disease (urothelial and bladder cancer subjects are not required to have failed prior chemotherapy regimen if considered unfit for cisplatin-based chemotherapy)
Patients who have failed bendamustine-based regimen previously
Patients must be considered candidates for intensive chemotherapy treatment with standard doses of cytarabine and anthracycline regimen (“7+3 regimen”)
Have relapsed or refractory disease after at least 1 prior regimen, including: \r\n* Recurrence of disease after a documented complete response (CR) \r\n* Progression of disease after a partial response (PR) to the prior regimen \r\n* Partial response (PR), stable disease (SD) or progressive disease (PD) at the completion of the prior treatment regimen; if a patient has PR to prior regimen without PD, there must be biopsy-proven residual disease that is measurable
For advanced (stage III/IV) Hodgkin disease, patients must have failed an Adriamycin containing regimen (adriamycin-bleomycin-vinblastine-dacarbazine [ABVD]) or an alternative non-cross resistant regimen (e.g. mustargen-oncovin-procarbazine-prednisone [MOPP])
DONOR: Is approved and completed evaluation prior to recipient initiation of the preparative regimen per institutional guidelines
Prior treatment with (or intolerance to) at least one standard systemic regimen for the patient's respective tumor
There will be no limit to number of prior myelosuppressive regimen for GIST or other tumor manifestations associated with NF1
Has evidence of progression on or after the last regimen received:
Patients underwent >= 1 prior chemotherapy-based or immunotherapy-based regimen or targeted therapy (e.g., inhibitors of BTK, PI3K etc.) administered for >= 2 cycles, and have had either documented disease progression or no response (stable disease) to the most recent treatment regimen
Patient must have prior treatment with a platinum plus pemetrexed regimen
More than one systemic therapy regimen of any type for metastatic or locally advanced disease; adjuvant gemcitabine that ended more than 6 months prior to diagnosis of recurrent disease is not considered as a regimen
Incurable cervical or anal cancer, as defined by:\r\n* Relapsed or progressive disease at the primary site and/or regional lymph nodes after initial treatment (e.g. systemic chemotherapy) with no potentially curative option (i.e. surgery or chemoradiotherapy); chemotherapy administered in conjunction with primary radiation as a radiosensitizer will not be counted as a systemic chemotherapy regimen; OR\r\n* Distant metastasis refractory to initial treatment (at least one prior chemotherapeutic regimen which can include a single chemotherapeutic, a combination of chemotherapeutics, or biologic drugs); cervical cancer subjects with distant metastases will have received and failed bevacizumab prior to enrollment onto the trial
Treatment with other chemotherapy regimen within the past 2 weeks
Participants must have received at least one prior chemotherapy regimen for their disease
Concurrent systemic high-dose corticosteroids when used intermittently in an antiemetic regimen, for central nervous system (CNS) metastases management, or as a part of the premedication regimen are allowed
Left ventricular ejection fraction of at least 40% (myeloablative regimen 1, reduced intensity regimen 3)
Pulmonary function test (PFT) demonstrating an adjusted diffusion capacity of least 50% predicted value for hemoglobin concentration (myeloablative regimen 1, reduced intensity regimen 3)
Serum glutamate pyruvate transaminase (SGPT)/bilirubin < to 2.0 x normal (myeloablative regimen 1), reduced intensity regimen 3; SGPT/bilirubin < to 4.0 x normal (nonmyeloablative regimen 2)
Patients must have received at least 1 prior regimen
Failed at least 1 prior chemotherapy regimen for advanced NSCLC
Any other condition that, according to the investigator, may forbid the administration of the idarubicin + cytarabine regimen
Patients who have received more than 1 prior therapy; NOTE: Prior therapy is defined as any single agent or combination regimen that is included as treatment for symptomatic CLL; treatment(s) given prior to the symptomatic phase of the disease (preventive strategy) will not be considered as prior induction therapy; for the purpose of a particular therapy/regimen to be counted towards the number of prior treatments a patient must have received at least 2 cycles of the induction regimen e.g., a patient who change their treatment regimen after only 1 cycle (due to toxicity or any other reason) will not be considered to have \2\ prior therapies
Concurrent systemic high-dose corticosteroids when used intermittently in an antiemetic regimen for central nervous system (CNS) metastases management or as a part of the premedication regimen are allowed
Patients may not have received more than 3 prior regimens, where the regimen intent was to induce remission
Phase II: patients are eligible if their previous chemotherapy regimen did not contain bortezomib, carfilzomib, or other known proteasome inhibitor or a combination of gemcitabine >= 800 mg/m^2 plus adriamycin >= 30 mg/m^2; patients who receive sequential or alternating therapy as part of front-line treatment will be counted as having one prior regimen; patients who have failed prior neoadjuvant chemotherapy will be eligible for this trial
Patients who have already started or received multi-drug consolidation regimen post-transplant expect for patients receiving up to 4 months of single agent  lenalidomide maintenance
Prolymphocytic leukemia (PLL) T-cell (T)-CLL\r\n* T-PLL: treatment failure after Campath-1H and at least one other regimen\r\n* B-PLL: treatment failure after fludarabine and at least one other salvage regimen
Burkitt or lymphoblastic lymphomas\r\n* High-risk disease in remission\r\n* Progression after >= 1 previous regimen\r\n* Non-CR after salvage regimen
Able to initiate study treatment no later than 6 weeks from last dose of any antineoplastic component of prior therapy regimen
Patients must be ineligible for, refused or having failed at least one previous salvage regimen
Participants for the phase 2 portion of the study must, in addition, meet the following: o Must be refractory to or relapsed after no more than 2 prior chemotherapy regimens. Re-induction with the same regimen or stem cell transplant will not be considered a separate regimen.
Cardiac disease (history of and/or active disease) that would preclude the use of any of the drugs included in the treatment regimen. This includes but is not confined to:
More than one prior systemic therapy regimen for metastatic pancreatic cancer (radiosensitizing doses of 5-FU or gemcitabine at the time of initial radiotherapy do not count as a prior systemic therapy regimen)
Patients with more than one prior chemotherapy regimen for management of primary disease
Detectable tumor prior to mobilization regimen
Have received at least one prior chemotherapy regimen for SCLC
Has had prior therapy with more than one cytotoxic chemotherapy regimen NOTE: Treatment with maintenance therapy after initial chemotherapy will not be considered a separate regimen and will be allowed.
Participants must be considered by their physician eligible to receiving the IRD regimen.
Previously treated with not more than 1 doublet or triplet regimen and that regimen contained gemcitabine and a platinum agent
Patients who have been treated with more than one chemotherapy regimen, immunotherapy regimen or chemotherapy/immunotherapy regimen for metastatic non-small cell lung cancer
Received at least one prior treatment regimen;historically documented CD20-positivity is acceptable;
Patients with MCL underwent >= 1 chemoimmunotherapy-based regimen; patients with FL and MZL underwent >= 1 prior chemotherapy-based and/or immunotherapy-based regimen; patients with DLBCL and CLL in Richter’s transformation underwent >= 1 chemoimmunotherapy-based regimen and are not transplant-eligible; patients with CLL, B-PLL and LPL underwent >= 1 chemotherapy-based, or immunotherapy-based or targeted therapy regimen (e.g., PI3K inhibitors [idelalisib], venetoclax, ibrutinib or an investigational agent, including an investigational BTK inhibitor); all regimens must have been administered for >= 2 cycles, and patients must have had either documented disease progression or no response (stable disease) to the most recent treatment regimen
High dose TBI regimen: 18 to =< 45 years
Intermediate intensity regimen: 18 =< 65 years
The regimen under study must constitute a reasonable therapeutic option
No more than one prior chemotherapy regimen for advanced or metastatic breast cancer is allowed; prior chemotherapy for metastatic disease must have been completed >= 14 days prior to randomization\r\n* Any single agent therapy, and any combination of cytotoxic, endocrine, biological targeted agents, and/or humanized antibodies, scheduled to be administered as a preplanned treatment, given concomitantly, sequentially or both, is considered one regimen\r\n* Planned neoadjuvant chemotherapy and postoperative adjuvant chemotherapy is considered one regimen\r\n* If the dosing of one or more of the chemotherapy components of a regimen must be reduced for toxicity, the modified version of the original regimen is not considered a new regimen\r\n* If one or more of the chemotherapy components of a regimen must be omitted for toxicity, the modified version of the original regimen is not considered a new regimen\r\n* If one of the chemotherapy components of a regimen must be replaced with another similar drug of the same therapeutic class, the modified version of the original regimen is not considered a new regimen; however, if a new component, dissimilar to any of the original components, is added to the regimen, the modified version is considered a new regimen\r\n* If chemotherapy is interrupted for surgery or radiotherapy and then continues with an unchanged schedule and components, treatment is considered as one regimen despite the interruption
HIV seropositive participants must be on antiretroviral therapy (ART) with the following criteria:\r\n* A complete ART regimen that does not include the study drug as one of a minimum of 3 active drugs, which may include an integrase inhibitor or efavirenz in combination with nucleoside reverse-transcriptase inhibitors (NRTIs)\r\n* The ART regimen must not include protease inhibitor (PIs); participants must not have received a PI-based regimen for at least 4 weeks prior to enrollment\r\n* Participants must either have an undetectable HIV plasma ribonucleic acid (RNA), or if plasma RNA detectable, must be on the same stable regimen for a minimum of 12 weeks prior to study enrollment\r\n* No minimum cluster of differentiation (CD)4 count, but maximum HIV plasma RNA of 1,000 copies/mL
Participant has received more than one prior systemic therapy regimen for SCLC.
Patients must have been pretreated for advanced disease - the number of prior systemic therapy/regimen depends on which origin for NET and for GEP-NEC
Patients must have received < 3 lines of prior therapy and have relapsed less than a year from their last platinum regimen; regimens that are used twice (for example carboplatin and paclitaxel) can be counted as one; if a regimen is changed during the course of treatment due to side effect profile or allergy, the course of therapy is counted as one regimen; (for example, if docetaxel is substituted for paclitaxel due to a reaction during the initial course of adjuvant therapy, this is considered one regimen)
More than 2 prior chemotherapy regimens for the current malignancy; full dose chemotherapy used in conjunction with concurrent radiation therapy will be included as prior therapy\r\n* Note: Prior hormonal therapy (e.g. leuprolide, aromatase inhibitors, tamoxifen) and immunotherapy will be allowed and not included as a prior chemotherapy; if the chemotherapy regimen is altered during the course due to issues with tolerability or safety, the regimen will be counted as one; using the same regimen at recurrence is counted as one regimen; the addition of bevacizumab to a prior regimen is considered one regimen
Stable, continuous antiretroviral treatment for at least three months before enrollment, defined as a multi-drug regimen (excluding azidothymidine [AZT])
At least 14 days must lapse between last prior anti-cancer treatment and 1st day of preparative regimen
All treatment regimens must have been administered for ?2 cycles unless patient is immediately allergic or intolerant to the regimen
Disease specific therapies within 1 week of starting conditioning regimen
Patients must have had one prior systemic chemotherapeutic regimen for management of persistent, recurrent or metastatic carcinoma of the cervix (e.g.; paclitaxel/cisplatin, paclitaxel/cisplatin/bevacizumab); chemotherapy administered concurrent with primary radiation (e.g.; weekly cisplatin) is not counted as a systemic chemotherapy regimen; adjuvant chemotherapy given following the completion of radiation therapy (or concurrent chemotherapy and radiation therapy) is not counted as a systemic chemotherapy regimen (e.g.; paclitaxel and carboplatin for up to 4 cycles); NOTE: patients who have received more than one prior regimen are NOT eligible
Patients must have received at least one prior regimen of chemotherapy for symptomatic multiple myeloma; patients may not have more than six (6) previous regimens of therapy for the disease; prior chemotherapy must have been completed at least 21 days prior to registration; for study purposes, a regimen is defined as follows:\r\n* An anti-myeloma therapy used at the time of initial diagnosis or documented disease progression which is given with the intent to decrease disease burden\r\n* Any maintenance therapy used after an Induction should be considered part of that Induction regimen\r\n* Use of any agent or combination of agents more than once during the patient’s disease history for separate documented disease progressions will be counted as separate regimens (e.g., if a patient receives lenalidomide/bortezomib at initial diagnosis and achieves response, but then progresses and receives lenalidomide/bortezomib after progression, these count as 2 separate regimens)\r\n* In cases of allogeneic or autologous stem cell transplant, the entire induction + stem cell mobilization + conditioning + planned maintenance should be considered one regimen
Patients who have relapsed from their initial doxorubicin, bleomycin, vinblastine and dacarbazine (ABVD) or similar standard treatment regimen and have not received any other chemotherapy or salvage systemic treatment
Participants on an antiretroviral regimen should be receiving treatment that is in accordance with the current International acquired immune deficiency syndrome (AIDS) Society guidelines; the specific agents are at the discretion of the investigator and use of agents currently available on an expanded access basis is allowed but use of experimental antiretroviral agents or those containing zidovudine (including Combivir and Trizivir) are prohibited; changes to highly active anti-retroviral therapy (HAART) therapy may be made if medically necessary (toxicity, failure of regimen, etc.); antiretroviral naïve participants: participants who are not on HAART at study entry MUST begin therapy (utilizing the above guidelines) AFTER one cycle of chemotherapy has been completed under protocol; changes to HAART therapy may be made if medically necessary (toxicity, failure of regimen, etc.); concurrent therapy with zidovudine or a zidovudine-containing regimen (including Combivir and Trizivir) will be prohibited until 2 months following the participant’s completion of chemotherapy as part of this protocol; the use of cobicistat (e.g., Tybost), or cobicistat containing single tablet regimens (e.g., Stribild) is prohibited during concurrent chemotherapy under this protocol; participants taking cobicistat or cobicistat-containing single table regimens must switch to a different agent or regimen prior to enrollment, and will remain on the regimen until at least 2 months following treatment discontinuation; Cobicistat is a pure and potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitor and has the potential to increase the area under the curve (AUC) of CYP3A4 substrates; therefore, both vincristine and doxorubicin would have the potential for drug drug interaction (DDI) with cobicistat since they are CYP3A4 substrates
For advanced (stage III/IV) Hodgkin's disease, patients must have failed an adriamycin containing regimen (ABVD) or an alternative non-cross resistant regimen (e.g. MOPP)
Patients who have received more than one previous regimen of chemotherapy (maintenance is not considered a second regimen)
Must have received > or = 1 prior treatment regimen.
If the subject has DLBCL, there is no curative option with conventional therapy and the prior treatment included ? 1 prior combination chemoimmunotherapy regimen.
Must have achieved at least a minimal response (MR) to at least 1 prior anti-myeloma regimen before developing PD (relapsed)
A prior line of treatment is considered an induction regimen if it involves an approved or investigational cytotoxic chemotherapy agent, biological agent, and/or hypomethylating agent administered alone or in a combination regimen, with the intent to induce robust cytoreduction (i.e., CR).
A prior line of treatment is considered an induction regimen if it involves an approved or investigational cytotoxic chemotherapy agent, biological agent, and/or hypomethylating agent administered alone or in a combination regimen, with the intent to induce robust cytoreduction (i.e., CR).
Must be eligible to receive second-line standard-of-care chemotherapy with either 1) an oxaliplatin-based chemotherapy regimen, or 2) an irinotecan-based chemotherapy regimen
All patients must have received at least one prior therapy - 1 cycle of cytarabine containing regimen or 2 cycles of hypomethylating agent - before determination of refractory status (defined as response duration less than 3 months or no response)
Patients must have received as a minimum a first line chemotherapy regimen consisting of at least 2 of the following agents: doxorubicin, cyclophosphamide, ifosfamide, etoposide.
Patients must have had one and only one prior regimen of systemic therapy for metastatic disease unless the patient meets the criteria below
Previous single agent exposure to the selected chemotherapy regimen for randomisation.
More than one chemotherapeutic regimen given for R/M disease. Prior treatment with immunotherapy is allowed.
Carmustine ? 600 mg/m² received as part of the pre-transplant conditioning regimen
The subject has received at least 1 line of therapy in the metastatic or locally advanced disease setting. The subject has been documented to have progressed by determination of the investigator on a regimen containing an anti-HER2 agent as the most recent regimen or the most recent anti-HER2 regimen was discontinued for any toxicity, with the exception of a cardiotoxicity.
Patients must have relapsed after having achieved at least stable disease for at least one cycle of treatment to at least one prior regimen and then developed PD.
Patients must also have documented evidence of PD during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry (refractory disease).
Group A at least one prior regimen of therapy
Tumor relapse/progression within 6 months of completion of a cisplatin-based chemoradiotherapy regimen for the treatment of early stage tumors
Participants requiring anti-diabetic medications must be on a stable dose and regimen for >=4 weeks
Experimental therapies when given as separate regimen are considered as separate line of therapy
For patients with relapsed/refractory disease: patients may have previously received chemotherapy with a mitoxantrone- or cladribine-based regimen for MDS or AML; if that patient has received G-CLAM before and has been sensitive to this regimen, eligibility will be determined on a case-by-case basis by the study principal investigator (PI)
Subject must have received ? 1 prior treatment regimen(s)
Required drainage of ascites during the final 2 cycles of their last platinum-based regimen and/or during the period between the last dose of chemotherapy of that regimen and randomization to maintenance treatment in this study.
During the study period, subjects using hormonal therapy and bisphosphonates should maintain a constant dose and should not change existing regimen.
Receive only RIC regimen (i.e. Regimen A)
Patients must have had prior systemically administered platinum-based chemotherapy; pleural space washing with cisplatin does not constitute systemic administration; no more than two prior systemic therapeutic regimens are allowed (including biologics, targeted therapies), and at least one regimen must have been platinum-based; immunotherapy will not be counted as a prior regimen; neoadjuvant and/or adjuvant systemic therapy will not be counted as a prior regimen, assuming at least 12 weeks have elapsed between the end of neoadjuvant/adjuvant therapy and development of progressive disease; patients must have completed systemic therapy (including any chemotherapy, biologics, targeted and immunotherapies) >= 28 days (42 days for nitrosoureas or mitomycin C) prior to registration and have recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered
Participants must have received at least one prior platinum-based regimen for advanced cholangiocarcinoma and had progressive disease or become intolerable to the regimen
Patients must have received at least one prior systemic chemotherapy regimen for metastatic pancreatic cancer; they should have experienced disease progression or intolerable toxicity from that regimen
Use of a systemic treatment regimen for metastatic disease within 28 days preceding the first dose of AEB071 and BYL719
Patients who have received no more than 1 prior cytotoxic treatment regimen.
If receiving myelofibrosis therapy, must be on a stable dose of the same regimen for at least 2 weeks prior to screen date and through the screening period
Documented relapse or progressive disease on or after any regimen (subjects refractory to the most recent regimen are eligible)
Patients who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participation
Not appropriate for treatment with a purine-based analogue regimen (per National Comprehensive Cancer Network [NCCN] or European Society for Medical Oncology [ESMO] guidelines), including relapse ? 36 months from a purine-based chemoimmunotherapy regimen or relapse ? 24 months from a purine-based monotherapy regimen
Patients must have prior treatment with >= 2 cycles of lenalidomide and >= 2 cycles of bortezomib (either in separate regimens or as part of the same regimen) (primary refractory of subjects refractory to the most recent regimen are eligible)
Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study.
Must have received at least 1 prior platinum-based chemotherapy regimen but have received no more than 3 lines of prior chemotherapy regimens, with no limit to the number of lines of prior hormonal therapy. Front-line therapy may include neoadjuvant and adjuvant therapy and will be counted as 1 prior systemic regimen. Biological therapy (e.g. bevacizumab) administered as a single agent is considered a prior systemic regimen and not a prior chemotherapy regimen. Maintenance therapy is not considered its own regimen but should be included with the regimen that it follows.
Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
At least 2 prior chemotherapy regimens; at least one fludarabine or other nucleoside analog containing regimen; chemotherapy in combination with monoclonal antibody (Rituxan) will be considered one prior regimen, but single agent Rituxan will not be considered one prior regimen; single agent ofatumumab will be counted as a regimen
Age criteria:\r\n* High dose TBI regimen: 6 months to =< 45 years \r\n* Middle intensity TBI regimen: 6 months to =< 65 years\r\n* Conditioning regimen selection should be based on the underlying disease, presence of minimal residual disease (MRD), age, co-morbidities, attending physician, and site preference; conditioning regimen will not require stratification of the randomization due to heterogeneity in the cohort of eligible patients.
Relapsed after ? 2 prior chemotherapy regimens, including the following: First-line treatment with standard anthracycline-containing regimen (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone or equivalent). At least 1 additional combination chemotherapy regimen. Patients relapsed after or refractory to first prior chemotherapy- and/or immunotherapy-based regimen for aggressive NHL and not eligible for high-dose regimen followed by transplant. High-dose chemotherapy, or chemoradiotherapy with autologous stem cell transplantation is considered 1 regimen. Patients with CD20 expressing neoplastic cells must have received prior rituximab, if available.
Patients with primary AML should have received no more than two (2) prior cytotoxic containing salvage regimens. Reinduction with the same regimen or stem cell transplant will not be considered a separate salvage regimen. Change of drugs will be considered a salvage regimen. Unlimited FLT3 TKI therapy (even in combination with cytotoxics/hypomethylating agents) is allowed for patients enrolled in cohort B
For patients with HL or ALCL, subjects are eligible after failure of at least one prior multi-agent chemotherapy regimen
Patients previously treated with a bendamustine-containing regimen who did not achieve a response or who relapsed and required treatment within 24 months of treatment with that regimen
Subject had no response (i.e., stable disease only) to first-line therapy with R-Cyclophosphamide, Hydroxydaunomycin, Vincristine (Oncovin), Prednisone (R-CHOP) or an equivalent regimen;
Patients must have received at least one chemotherapy regimen which contained doxorubicin.
Subjects must have failed at least one previous chemotherapy regimen for metastatic disease if standard therapies exist
Patients who provide consent for placement of the IP port system, if randomized to Regimen II (Study treatment: dd-TCip therapy)
Patients had at least one prior regimen consisting of at least 1 cycle
Patients with AML and ALL should have received at least 1 prior treatment regimen and either failed to achieve response or relapsed on treatment
Patients with more than one previous chemotherapy regimen
Chronic lymphocytic leukemia (CLL) must have either \r\n * 1) Failed to meet National Cancer Institute (NCI) Working Group criteria for complete or partial response after therapy with a regimen containing FLU (fludarabine phosphate) (or another nucleoside analog, e.g. 2-chlorodeoxyadenosine [2-CDA], pentostatin) or experience disease relapse within 12 months after completing therapy with a regimen containing FLU (or another nucleoside analog) \r\n * 2) Failed FLU- CY (cyclophosphamide)-rituximab (FCR) combination chemotherapy at any time point; or \r\n * 3) Have \17p deletion\ cytogenetic abnormality and relapsed at any time point after any initial chemotherapy
Prolymphocytic leukemia (PLL), T-cell chronic lymphocytic lymphoma (T-CLL)\r\n* T-PLL: treatment failure after Campath-1H and at least one other regimen\r\n* B-PLL: treatment failure after fludarabine and at least one other salvage regimen
Left ventricular ejection fraction of at least 40% (myeloablative regimen 4, reduced intensity regimen 3) or 30% (nonmyeloablative regimen 2)
Creatinine < 1.6 mg/dL (myeloablative regimen 4, reduced intensity regimen 3) or < 3.0 mg/dL (nonmyeloablative regimen 2)
Serum glutamate pyruvate transaminase (SGPT) =< to 2.0 x normal (myeloablative regimen 4, reduced intensity regimen 3) or =< 4.0 x normal (nonmyeloablative regimen 2)
Bilirubin =< to 2.0 x normal (myeloablative regimen 4, reduced intensity regimen 3) or =< 4.0 x normal (nonmyeloablative regimen 2)
TIER I SUBJECTS: Patients with relapsed follicular lymphoma achieving at least a PR following their most recent systemic chemotherapy and/or immunotherapy regimen; Tier I subjects must have had at least two prior chemotherapy and/or immunotherapy regimens; partial response from pre-study regimen may be either a clinically determined response by the principal investigator or physician co-investigator member of the study team, or a measured response as per the response criteria of this protocol
Progressed or intolerant to at least 1 approved prior anticancer regimen.
More than one prior treatment regimen for ALL or LL
Has experienced failure of at least 1 prior chemotherapy regimen:
Insufficient time from last prior regimen or radiation exposure (washout period of 4 weeks)
Participants must be on a stable antiretroviral regimen per current International Acquired Immunodeficiency Syndrome (AIDS) Society guidelines as follows, with no intention of changing the regimen within 8 weeks after ibrutinib initiation:\r\n* Choice of regimen: The specific antiretroviral agents are at physician discretion, and the use of investigational agents currently available on an expanded-access basis is allowed; use of experimental antiretroviral agents or those containing zidovudine (including Combivir and Trizivir) is prohibited\r\n* Patients with mantle cell lymphoma, CLL, or SLL must be on non-cytochrome P450, family 3, subfamily A, polypeptide 4 (CYPA3A4) modulating antiretroviral agents (Stratum C) to be eligible for this study\r\n* Patients may be switched to non-conflicting regimens in order to participate\r\n* Stability of regimen: With the exception of patients on zidovudine-based ART, any changes in antiretroviral regimen must be made at least 4 weeks prior to ibrutinib initiation; patients taking zidovudine-based ART must change to a non-zidovudine-based regimen at least 2 weeks prior to ibrutinib initiation; changes to ART therapy during the study may be made if medically necessary (e.g. toxicity, treatment failure)
4. Received only one prior chemotherapy regimen consisting of ? 4 cycles of pemetrexed/cisplatin or pemetrexed/carboplatin; subjects must have documentation of an ongoing response (confirmed PR or SD) following completion of this regimen. Subjects changing from cisplatin to carboplatin or vice versa within the same course of treatment because of platinum toxicity will be considered to have had first-line chemotherapy. Note: Subjects may have undergone previous surgical resection of their disease providing it was completed prior to initiation of chemotherapy.
Histologically confirmed biliary tract or gallbladder cancer that have relapsed or are refractory after one prior gemcitabine-based chemotherapy regimen for advanced biliary cancer
Treatment with more than one prior chemotherapy regimen
Receipt of prior chemotherapy (CT) or radiation therapy (RT) for PTCL, other than a single allowed CHOP regimen, except:
MESOTHELIOMA COHORTS (COHORTS 1 AND 2 ONLY): Patients must have had at least one prior chemotherapy regimen, with the Food and Drug Administration (FDA)-approved regimen of a platinum-based therapy in combination with pemetrexed being preferred unless there was a specific contraindication for an individual patient; there is no limit to the number of prior chemotherapy regimens received
Patients with relapsed chronic lymphocytic leukemia with high risk features: lack of objective response or relapse within 6 months following nucleoside-analogue based chemotherapy regimen or patients with 17p deletion CLL who lacked objective response to at least 1 preceding chemotherapy regimen
Patients with malignant pleural disease (MPD), pathologically confirmed at Memorial Sloan-Kettering Cancer Center (MSKCC) (radiographic confirmation is acceptable for screening phase eligibility), and defined as one of the following (patients who have not yet received treatment may enroll in the screening portion only):\r\n* Malignant pleural mesothelioma – previously treated with at least one prior treatment regimen\r\n* Non-small cell lung cancer metastatic to the pleura—previously treated with at least one prior treatment regimen (chemotherapy, surgery, or targeted agent) and documented progression of disease; patients with disease outside of the pleura will be discussed among study principal investigator (PI) and Co-Pls prior to considered eligible for the study; disease outside of the pleura must not require any immediate therapy per PI’s discretion\r\n* Breast cancer metastatic to the pleura— previously treated with at least one prior treatment regimen (chemotherapy, surgery or targeted agent) and documented progression of disease; patients with disease outside of the pleura will be discussed among study PI and Co-Pls prior to considered eligible for the study; disease outside of the pleura must not require any immediate therapy per PI’s discretion
Any of the following as this regimen may be harmful to a developing fetus or nursing child:
Maximum one prior systemic therapy regimen.
Participants must have received at least one prior chemotherapy regimen for AGC;\n             prior therapy does not need to have included HER2-directed therapy.
A) Dose Escalation Stage: Confirmed diagnosis of relapsed or refractory Non-Hodgkin Lymphoma (NHL) treated with prior treatment for lymphoid malignancy comprising of at least 1 regimen containing a therapeutic anti-CD20 antibody (eg, rituximab, ofatumumab, GA-101) and at least 2 prior combination chemotherapy regimens (or autologous stem cell transplant) , or treated with 1 prior combination chemotherapy regimen in patients without an approved second-line therapy option, requiring treatment in the opinion of the treating physician
Expansion Cohort A: Relapsed or refractory DLBCL treated with prior treatment for lymphoid malignancy comprising of at least 1 regimen containing a therapeutic anti-CD20 antibody (eg, rituximab, ofatumumab, GA-101) and at least 2 prior combination chemotherapy regimens or autologous stem cell transplant, or treated with 1 prior combination chemotherapy regimen in patients without an approved second-line therapy option, requiring treatment in the opinion of the treating physician
Expansion Cohort B: Diagnosis of relapsed or refractory B-cell NHL (other than DLBCL) treated with prior treatment for lymphoid malignancy comprising of at least 1 regimen containing a therapeutic anti-CD20 antibody (eg, rituximab, ofatumumab, GA-101) and at least 2 prior combination chemotherapy regimens or autologous stem cell transplant, or treated with 1 prior combination chemotherapy regimen in patients without an approved second-line therapy option, requiring treatment in the opinion of the treating physician
> 1 prior regimen
Disease refractory to last myeloma regimen.
Previously received one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least PR or documented PD after, the most recent systemic treatment regimen
Patients must have received one of the regimens listed below for their platinum sensitive disease; the number of treatment cycles should not have exceeded 8 cycles of 1 regimen in the recurrent setting; the most recent dose of the regimen must have been given within 3 to 8 weeks prior to the first dose of study drug; there is a required 3 week washout from the last dose of chemotherapy; if greater than 8 weeks have passed since the last chemotherapy dose, patients may be eligible with documented approval of the Principal Investigator\r\n* Platinum (carboplatin or cisplatin) and taxane (paclitaxel or docetaxel)\r\n* Carboplatin and gemcitabine\r\n* Carboplatin and liposomal doxorubicin\r\n* Any other carboplatin doublet (including carboplatin and pralatrexate) with documented approval of the Principal Investigator
Bevacizumab-naïve patients: these patients may not have more than one prior relapse not counting the current relapse being treated by this protocol and must have received at least one prior chemotherapy regimen, which must have included temozolomide
For the Phase 1b portion of the study, more than 3 prior chemotherapy regimens and for the Phase 2 portion of the study more than 2 prior chemotherapy regimens. Maintenance therapy following induction chemotherapy does not count as a separate regimen. In addition, hormonal therapy (e.g., tamoxifen or an aromatase inhibitor) does not count as a separate regimen.
Pregnant or lactating in female patients, if applicable (childbearing potential who have received a reduced intensity conditioning regimen)
At least 1 prior regimen must have contained a platinum salt
'Adjuvant therapy' will constitute a prior treatment regimen
Any prior chemotherapy must have been completed >= 2 weeks prior to day 1 of study treatment and the participant must have recovered to eligibility levels from prior toxicity\r\n* Only one prior regimen is allowed for relapsed AML patients; note one prior regimen is defined as follows:\r\n** Induction chemotherapy followed by consolidation is considered one regimen\r\n** Induction chemotherapy followed by re-induction in case of persistent disease followed by consolidation is considered one regimen\r\n* Hydroxyurea is allowed prior to day 1 of study treatment to keep white blood cell (WBC) below 20 K
Patients with transformed CTCL eligible for CHOP regimen
Subjects must not have had more than 1 previous treatment regimen with chemotherapy, interferon, or IL-2 for metastatic melanoma
More than 1 prior systemic regimen (prior MET inhibitors/antibodies are not allowed; experimental systemic therapy for inoperable HCC given before or after sorafenib counts as separate regimen and is not allowed)
If the participant has received prior bendamustine, response duration must have been greater than (>) 1 year (for participants who have relapse disease after a prior regimen)
On a stable parental study regimen (at least one cycle for the regimen at the dose/schedule that is to be given in the Treatment Extension study must have been given prior to the patient's discontinuation from the parental study). Signed written informed consent.
All patients must be prescribed combination antiretroviral therapy with the goal of virological suppression using an acceptable regimen that adheres to national guidelines for treatment of HIV infection; non-suppressed, treatment experienced patients, defined as patients with a viral load > 400 copies/mL who have been on antiretroviral therapy for more than 4 months can be enrolled if an alternative ART regimen is available that includes at least two ART drugs that, in the opinion of the site investigator, are expected to have activity based on genotypic testing (if available) and treatment history
An interval of at least 3 months from the completion of most recent radiation therapy; at least 4 weeks from a non-nitrosourea chemotherapy regimen and at least 6 weeks from a nitrosourea containing regimen
Have received or refused at least one chemotherapy regimen
Recipient must have no evidence of active infection at the time of the transplant preparative regimen or at time of transplantation.
Documentation for inclusion criteria histologically proven, unresectable, locally advanced or metastatic liposarcoma (dedifferentiated, myxoid round cell, or pleomorphic) or leiomyosarcoma. Participants must have a pathology report indicating the diagnosis of liposarcoma or leiomyosarcoma that has been reviewed by the sponsor before randomization may occur and treated in any order with at least: an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen do not need to be reviewed by the Sponsor
Participating patients must receive medically appropriate care and treatment for HIV infection, including antiretroviral medications, when clinically indicated, and should be under the care of a physician experienced in HIV management; with the exception of treatment with zidovudine and stavudine, patients will be eligible regardless of antiretroviral regimen (no antiretroviral therapy, nonnucleoside reverse transcriptase inhibitors [NNRTI]-based therapy, or protease inhibitor based therapy), provided there is no intention to initiate therapy or the regimen has been stable for at least 4 weeks with no intention to change the regimen within 8 weeks following study entry; the exact regimen used for HIV therapy will be captured on Case Report Forms; as study-specific (antiretroviral therapy-based) strata fill, however, only patients fitting the remaining open strata will be accrued
Has received ? 3 prior chemotherapy regimens in any setting (a regimen is defined as any agent[s] that has been administered for more than 1 cycle; sequential neoadjuvant/adjuvant treatment is considered 1 regimen)
Patients with recurrent or progressive advanced stage NSCLC (no small cell lung cancer [SCLC] component) who have been treated with at least one and a maximum of two prior chemotherapy regimens for advanced NSCLC; chemotherapy as part of initial potentially curative therapy (given as part of adjuvant or concomitant chemoradiotherapy) that was completed < 1 year counts as 1 prior regimen; prior erlotinib, other EGFR tyrosine-kinase inhibitors (TKIs) or monoclonal antibodies targeting EGFR are not allowed; NOTE: Chemotherapy as part of initial potentially curative therapy (given as part of adjuvant or concomitant chemoradiotherapy) that was completed one or more years prior to screening for this study does not count as a prior regimen; if the tumor is refractory (progressed) after a prior chemotherapy regimen, then that regimen would count; if a prior chemotherapy regimen has been changed due to other reasons than disease progression (e.g. poor tolerance, allergic reaction), then it would not count as a separate prior regimen; a chemotherapy drug added for “maintenance” following disease stabilization or response to a chemotherapy regimen (in the absence of prior disease progression) does not count as a separate prior regimen; NOTE: Pathology reports documenting the diagnosis of NSCLC are required to be reviewed by the screening physician investigator
Achieved a response to at least one prior regimen
Suitable for either treatment regimen.
Subjects must be discontinued from ipilimumab or nivolumab as monotherapy or with the combination regimen
Be scheduled to receive an antiemetic regimen that does not contain Akynzeo; in addition, the antiemetic regimen must conform with American Society of Clinical Oncology (ASCO) Clinical Practice Guidelines at cycle 1
Plan to start a new cancer treatment regimen within 4 weeks from time of baseline registration; the treatment regimen is up to the discretion of the treating oncology physician; the regimen must include a chemotherapy drug or other agents that have similar prevalence of toxicity; patients who will receive monoclonal antibody therapy or other cancer therapies (e.g., tyrosine kinase inhibitors) are eligible if the other agents present a prevalence of toxicity similar to chemotherapy; these therapies can be used in combination with chemotherapy, as a single agent, or in combination with each other\r\n* Chemotherapy will be defined as cytotoxic drugs; in addition, agents (e.g., monoclonal antibodies and targeted agents) that have a prevalence of grade 3-5 toxicity in older patients similar to chemotherapy (> 50%) will be allowed; a list of allowable agents (single and in combination) meeting this toxicity criteria will be available on the University of Rochester Cancer Center (URCC) NCORP Research Base website as part of the study materials; given the rapidly changing landscape of new drugs for cancer, the study team led by the principal investigator (PI) will update the list accordingly after reviewing the toxicity profile of new therapies; if the potentially eligible participant is to receive an approved drug or regimen not on the list, contacting the URCC NCORP Research Base study team is required for approval prior to participant enrollment\r\n* Patients who are receiving approved cancer treatment in combination with radiation are eligible\r\n* A patient may also be enrolled on a treatment trial and participate in this study, if all other inclusion and exclusion criteria are met
Must be starting a new chemotherapy regimen (patients whose treatment regimen includes an immunomodulatory agent such as lenalidomide or small molecule targeted agents such as ibrutinib or idelalisib will be included in the study; patients being treated with a single agent monoclonal antibody will not be included)
Patients on ongoing chemotherapy regimen at the time of eligibility:
BC patients scheduled to undergo chemo regimen other than the 12-week, 16-week, 18-week, 20-week, or 24-week regimen
Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug. Additional Exclusion Criteria for the SC-006 and ABBV-181 Combination Treatment Regimen:
Preparative regimen: both reduced intensity and ablative regimens are permitted; each center will pre-specify the regimen they intend to use during the conduct of the study
Subjects who have taken a neurokinin antagonist within 14 days prior to beginning the BEAM regimen
Scheduled to start a new treatment regimen for MBC, but no more than 3 previous chemotherapy regimens
Planned chemotherapeutic regimen for subject must meet all of the following criteria:\r\n* A known myelosuppressive regimen which includes a combination of at least two of the following agents: actinomycin, carboplatin, cisplatin, cyclophosphamide, daunorubicin, doxorubicin, etoposide, ifosfamide, topotecan\r\n* At least 4 consecutive cycles\r\n* Cycle length is either 14 or 21 days\r\n* Regimen must either alternate chemotherapeutic agents in an X-Y-X-Y format, such that the same chemotherapy is given every other cycle (e.g. vincristine/doxorubicin/cyclophosphamide | ifosfamide/etoposide), or repeat the same chemotherapeutic agents each cycle in an X-X-X-X format (e.g. repeated cycles of cisplatin/etoposide/bleomycin); questions regarding whether or not a patient’s chemotherapy plan meets inclusion criteria will be decided by the study chair
Planned to initiate a new systemic chemotherapy regimen (including patients starting on first chemotherapy or patients previously treated but starting on a new regimen)
ONCOLOGY PATIENTS: patients with an oncology diagnosis that are or will be on a chemotherapy regimen that will last for an additional >= 3 months or are on or will be on a chemotherapy regimen for < 3 months and then proceed to transplant (allogeneic or autologous stem cell rescue) during the 3-month study period
Starting a new treatment regimen that includes a single oral anticancer medication
At least one prior chemotherapeutic regimen for advanced metastatic/recurrent disease, of which at least one regimen included a platinum agent (unless contraindicated)
Treated with any established chemotherapy regimen based on either:
Chemotherapy regimen: Docetaxel/carboplatin. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, & 3.
Chemotherapy regimen: Docetaxel/cyclophosphamide. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, & 3. Note: Fosaprepitant will be allowed in place of aprepitant, and either granisetron or ondansetron, on one or more days, will be allowed in place of palonosetron.
Nonmyeloablative preparative regimen
ANNUAL SCREENING REGIMEN ELIGIBILITY CHECK
Planned reduced intensity conditioning regimen (see eligible regimens in Table 2.4a)
Receiving a stable dose of octreotide LAR as a part of a treatment regimen for >= 3 months
Patients must have planned treatment with doxorubicin:\r\n* Patients with sarcoma must have an initial planned regimen including 75 mg/m^2 doxorubicin for at least 4 cycles; NOTE: patients can be on additional chemotherapeutic agents \r\n* Patients with lymphoma must have an initial planned regimen including 50 mg/m^2of doxorubicin for at least 6 cycles; NOTE: patients can be on additional chemotherapeutic agents\r\n* Patients with breast cancer must have an initial planned regimen including 60 mg/m^2 of doxorubicin for at least 4 cycles; breast cancer patient enrollment will stop once 60 breast cancer patients have been enrolled; NOTE: patients can be on additional chemotherapeutic agents
Had at least 1 prior anti-MM regimen and no more than 3 prior anti-MM regimens. Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 anti-MM regimen.
Pregnant women are excluded from participation due to inability to participate in required chemotherapy regimen