[c09aa8]: / clusters / clusters342final / clust_59.txt

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Patients with acute promyelocytic leukemia (APL) confirmed either by the presence of t(15;17)(q22;q21) or promyelocytic leukemia (PML)/retinoic acid receptor (RAR) alpha transcripts will be excluded
Patients must not have blastic transformation of chronic myelogenous leukemia
Patients with secondary AML are eligible for enrollment onto the trial; secondary AML is defined as AML that has developed in a person with a history of antecedent blood count abnormalities, or myelodysplastic syndrome (MDS), or a myeloproliferative disorder (excluding chronic myeloid leukemia); or a history of prior chemotherapy or radiation therapy for a disease other than AML* NOTE: Prior therapy of MDS with decitabine, low-dose cytarabine, or azacitidine is excluded
Patients may not have received prior chemotherapy for AML with the exception of hydroxyurea for increased blast count or leukapheresis for leukocytosis; patients who have received a limited and short-term exposure of ATRA (all trans retinoid acid) while AML-M3 (acute promyelocytic leukemia) was being ruled out, and which has been discontinued, will be eligible
B-ALL patients with testicular leukemia are not eligible for AALL0932
Patients with acute myelogenous leukemia (AML) or relapsed acute lymphoblastic leukemia (ALL) that will receive chemotherapy with/without transplant must have, or be scheduled to have, an external tunneled CVC (Broviacs, Hickmans, tunneled PICCs, etc.) and/or non-tunneled PICC that is expected to remain in place for an additional >= 3 months
The following malignancies will be considered eligible if progressive or persistent:* Chronic lymphocytic leukemia (CLL)* Non-Hodgkin lymphoma (NHL)* Hodgkin lymphoma (HL)* Multiple myeloma (MM)* Acute leukemia (acute myeloid leukemia [AML], acute lymphoblastic leukemia [ALL])* Myelodysplastic syndrome (MDS)* Myeloproliferative neoplasms (MPN)* Chronic myeloid leukemia (CML)
Patients must have a diagnosis of relapsed or refractory CD22-positive acute leukemia including B-ALL, mixed phenotype leukemia (biphenotypic), or Burkitts leukemia based on World Health Organization (WHO) classification; patients with bilineal leukemia are excluded
Patients must have histologically or cytologically confirmed: * Pathologically confirmed intermediate or poor risk newly diagnosed AML (subtypes M0, 1, 2, 4-7), but excluding newly diagnosed core-binding factor (CBF) (t(8;21) or M4eo subtype (inv(16) or t(16;16) AMLs and acute promyelocytic leukemia (acute promyelocytic leukemia [APL], M3)* MDS with high risk features as defined by intermediate (INT)-2 or high International Prognostic Scoring System (IPSS) score with > 10% blasts in the bone marrow* Chronic myelomonocytic leukemia-2 (CMML-2) defined as having > 10% blasts (including promonocytes) in the bone marrow or 5-19% blasts (including promonocytes) in the peripheral blood
Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia are not eligible
Patients with T-lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (T-LL) are not eligible
Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML
Patients with isolated myeloid sarcoma (myeloblastoma, chloroma, including leukemia cutis) but without evidence of APL by bone marrow or peripheral blood morphology are excluded
Patients must have one of the following, histologically or cytologically confirmed:* Acute myeloid leukemia (AML) [non- acute promyelocytic leukemia (APL) AML]** If previously treated:*** AML that is relapsed or refractory to at least one prior line of therapy** If previously untreated, must meet all of the following:*** >= 60 years of age*** Secondary or therapy-related AML*** Does NOT bear favorable cytogenetic and/or molecular features, eg, core-binding factor abnormalities, FLT3 Internal Tandem Duplication (FLT3-ITD) negative/NPM1 mutated, biallelic CCAAT/enhancer binding protein alpha (CEBPA) mutation without FLT3-ITD* Chronic myeloid leukemia blast crisis (CML-BC)** Relapsed or refractory to at least one Bcr-Abl-TKI-containing regimen* Myelodysplastic syndrome (MDS), must meet all of the following:** Higher risk MDS [intermediate-2 or high risk by the original International Prognostic Scoring System (IPSS)]** Relapsed, refractory, or intolerant to at least one prior line of therapy containing hypomethylating agents (deoxyribonucleic acid [DNA] methyltransferase inhibitors)
Acute promyelocytic leukemia (APL, M3)
Patients with promyelocytic leukemia (French-American-British [FAB] M3)
Patients must not have acute promyelocytic leukemia (APL) and must not have evidence of t(15;17)(q22;q21)
No features suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated
Evidence suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated* No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUBCT)
Patients may not have features suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated
Patients must have the status of CNS1 or CNS2 only, and no clinical signs or neurologic symptoms suggestive of CNS leukemia, such as cranial palsy
Patients diagnosed with a leukemia or lymphoma as follows:* Chronic or acute leukemia forms of HTLV-1 associated adult T-cell leukemia;* Peripheral T-cell lymphoma (angioimmunoblastic, hepatosplenic, or not otherwise specified); or,* Cutaneous T-cell lymphoma stage III or IV with circulating monoclonal cells (B1 or B2) and/or erythrodermia (T4)* T-cell prolymphocytic leukemia (T-PLL)* NOTE: Diagnosis must be validated by the Pathology Department, National Cancer Institute (NCI)
Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia) or acute leukemia of ambiguous lineage (ALUL), which includes mixed phenotype acute leukemia (MPAL); for patients with ALUL, the morphology and immunophenotype must be at least 50% B lymphoblastic
Patients with known absence of KMT2A-rearrangement leukemia prior to enrollment
Patients with secondary B acute lymphoblastic leukemia (B-ALL) that developed after treatment of a prior malignancy with cytotoxic chemotherapy
No features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) on peripheral blood smear
Patients must have suspected refractory or relapsed pre-B cell ALL or mixed phenotype acute leukemia (MPAL), or if newly diagnosed, the patient must be 60 years of age or older
Patients must have histologically or cytologically confirmed by the local institution CD19+ precursor B-acute lymphoblastic leukemia (pre-B cell ALL) OR CD19+ mixed phenotype acute leukemia (MPAL): a) with relapse following or refractory to at least one prior line of therapy if older than 21 years; b) in second or higher relapse or refractory to at least two prior lines of therapy if 21 years old and younger (16-21); c) or they must have a new diagnosis of pre-B cell ALL or CD19+ MPAL but are >= 60 years old and are either not a candidate for or do not wish to receive traditional induction chemotherapy
Active leukemia in the testes or isolated extramedullary relapse; patients with a history of treated leukemia in testes but no active disease at the time of enrollment are eligible
Patients with myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML), or features suggestive of MDS/AML
No features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) on peripheral blood smear
Participants with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
Pathologically confirmed myelodysplastic syndrome (MDS) diagnosis (regardless of initial International Prognostic Scoring System [IPSS] risk category) or oligoblastic acute myeloid leukemia (AML) with 21-30% bone marrow (BM) blasts in whom DNMTi have failed; patients who have developed AML after DNMTi therapy can be enrolled as long as they have initiated DNMTi therapy while they were in the MDS or oligoblastic AML (20-30% BM blasts) phase and the study chair agrees; failure of DNMTis is defined as: failure to achieve a complete response (CR), partial response (PR) or hematologic improvement (HI) after at least 4 cycles of DNMTi or progressed after such therapy
Known history of chronic myelogenous leukemia (CML)
Patients with myelodysplastic syndrome/acute myeloid leukemia
Excluded tumor types* Melanoma* Bone sarcomas* Soft tissue sarcomas, including angiosarcoma, primary cutaneous leiomyosarcoma, dermatofibrosarcoma protuberans* Leukemias* Myeloid sarcoma, leukemia cutis, and chloroma* Hodgkins lymphoma* B cell lymphoma
Patients with primary tumors including germ cell tumor, or lymphoma/leukemia
No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys; when indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC