SWOG clinical trial number
S0805
Phase II Study of Combination of Hyper-CVAD and Dasatinib with or without Allogeneic Stem Cell transplant in Patients with Philadelphia (Ph) Chromosome Positive and/or Bcr-Abl Positive Acute Lymphoblastic Leukemia (ALL)
Closed
Phase
Accrual
100%
Published
Abbreviated Title
Phase II HyperCVAD + Dasatinib with or without Allo SCT for Ph+ ALL
Activated
09/01/2009
Participants
Research committees
Leukemia
Treatment
Cytosine Arabinoside
Cyclophosphamide
Dexamethasone
Vincristine
Doxorubicin
Leucovorin Calcium
Mesna
Methotrexate
G-CSF
Methyl Prednisolone
Dasatinib
Hyper-CVAD
Eligibility Criteria Expand/Collapse
Pts must have morphologic diagnosis of ALL with evidence of ALL involvement in bone marrow and/or blood. Pts with only extramedullary disease in the absence of bone marrow or blood involvement are not eligible. Pts with M0 AML, mixed lineage leukemia or L3 (Burkitts) are not eligible for this study. For ALL in marrow or peripheral blood, immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage (B cell, T-cell, or mixed B/T cell). NOTE: Appropriate marker studies including CD19 (B cell), CD10, CD5, and CD7 (T cell) must be performed. Coexpression of myeloid antigens (CD13 and CD33) will not exclude pts. If possible, the lineage specific markers cytoplasmic CD22 or CD79a (B cells), cytoplasmic CD3 (T cells) and cytoplasmic MPO (myeloid cells) must be determined. Pts may have received no more than one course of remission induction therapy for ALL. Pts who have received any post-remission therapy for ALL or who have relapsed from complete remission are not eligible. (Patients with previously untreated ALL can be eligible, and patients who have received one course of remission induction therapy for ALL can be eligible, regardless of their response to therapy.) Pts may have received no more than 14 days of tyrosine kinase inhibitor therapy prior to reg. Any prior induction chemotherapy must have been completed within 28 days prior to registration. For pts who have received any prior therapy that was NOT remission induction therapy, one of the following must be true: 1) At least 6 weeks must have elapsed since any monoclonal antibodies were given, at least 7 days must have elapsed since any other treatment was given, and all toxicities of the remission induction therapy must have resolved to Grade �� 2; or 2) The patient must have rapidly progressive disease (per institutional guidelines). For previously treated pts, the Study Coordinator must be contacted before registration, in order to determine the regimen to be given in the first course of induction/consolidation therapy, based on prior therapy. Patients must be Philadelphia (Ph) chromosome positive and/or BCR/ABL positive as confirmed by standard cytogenetics, FISH, and/or polymerase chain reaction (PCR) testing performed by local laboratory. NOTE: Samples will be submitted centrally for verification of results. Pts must have a bilirubin </= 3.0 x IULN within 14 days prior to registration. Pts must have SGOT (AST) </= 3.0 x IULN and/or SGPT (ALT) </= 3.0 x IULN within 14 days prior to registration. (If both are done, both values must be </= 3.0 x IULN. Pts must have a serum creatinine </= 3.0 x IULN within 14 days prior to registration. Patients must not have active pericardial effusion, ascites, or pleural effusion of any grade, or prolonged QTc interval (QTc > 480 msec). Patients must have Zubrod Performance Status of 0-2. Patients must be >/= 18 and </= 50 years of age. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the pt is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years. SWOG, BMTCTN and CALGB pts must have specimens submitted for cellular and molecular studies as outlined on the SWOG Specimen Submission webpage. SWOG and BMTCTN pts must have cyto performed by CLIA approved lab. CALGB pts must be registered to CALGB-8461 and CALGB-9665. ECOG pts must be registered to E3903.Pts must not be pregnant or nursing because of the teratogenic potential of the drugs used in this study. Women/men of reproductive potential must have agreed to use an effective contraceptive method. Women of reproductive potential must have a negative pregnancy test performed within 14 days prior to registration. Pts must not have prior history of known Type I hypersensitivity oranaphylactic reactions to doxorubicin. All pts (or authorized legal representative) must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base.
Publication Information Expand/Collapse
2020
Bias in mean survival from fitting cure models with limited follow-up
PMid: PMID32828215 | PMC number: PMC7446760
2018
Comparable Outcomes of Patients Eligible versus Ineligible for SWOG Leukemia Studies
PMid: PMID29618479 | PMC number: PMC6014358
2016
PMid: PMID29046900 | PMC number: PMC5642915
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