Chemotherapy, Imatinib Mesylate, and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Condition: Adult Acute Lymphoblastic Leukemia in Remission
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: imatinib mesylate; methotrexate; vincristine sulfate; leucovorin calcium; peripheral blood stem cell transplantation; autologous hematopoietic stem cell transplantation; allogeneic hematopoietic stem cell transplantation; total-body irradiation; tacrolimus; filgrastim; etoposide; cyclophosphamide; cytarabine; laboratory biomarker analysis
Intervention description: Given PO; Given IT and IV; Given IV; Given IV and PO; Undergo PBSCT; Undergo autologous PBSCT; Undergo allogeneic PBSCT; Undergo TBI; Given IV or PO; Given SC; Given IV; Given IV; Given IV; Correlative studies
Intervention MeSH terms: Leucovorin; Cytarabine; Cyclophosphamide; Methotrexate; Etoposide; Vincristine; Etoposide phosphate; Imatinib Mesylate; Tacrolimus; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 15 Years
Maximum age: 59 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well giving imatinib mesylate together with chemotherapy and
      peripheral stem cell transplantation works in treating patients with newly diagnosed acute
      lymphoblastic leukemia. Drugs used in chemotherapy use different ways to stop cancer cells
      from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer
      cells by blocking the enzymes necessary for cancer cell growth. Giving imatinib mesylate
      together with chemotherapy and peripheral stem cell transplantation may be an effective
      treatment for acute lymphoblastic leukemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Unequivocal histologic diagnosis of ALL

          -  Detection of the t(9;22)(q34;q11) or 3-way variant by metaphase cytogenetics or
             BCR-ABL positive by molecular analysis (RT-PCR or fluorescence in situ hybridization
             [FISH})

          -  Prior Therapy:

               -  Complete or partial remission following one course of induction chemotherapy with
                  an intensive 4 or 5 drug regimen (with or without imatinib mesylate) on a CALGB
                  or SWOG ALL protocol for previously untreated ALL patients

                    -  Note: The double induction regimen of SWOG S0333 is considered to be one
                       course of induction chemotherapy for the purpose of this eligibility
                       criterion; therefore, patients from S0333 may be eligible for this study
                       only after completing the entire double induction regimen

               -  Complete or partial remission following one course of therapy on any standard
                  induction regimen (with or without imatinib mesylate) without prior enrollment on
                  a cooperative group frontline protocol; in these instances, documentation of
                  Philadelphia chromosome (Ph)+ positivity may occur outside a CALGB or SWOG
                  laboratory

                    -  Note: CALGB institutions must enroll patients on CALGB 9862 and submission
                       of an initial sample for the companion trial must occur at time of
                       enrollment on CALGB C10001; enrollment on companion studies CALGB 8461 and
                       9665 is not required

          -  No more than six weeks of prior imatinib mesylate during induction therapy before
             study enrollment

          -  Non-pregnant and non-nursing; treatment under this protocol would expose an unborn
             child to significant risks; women and men of reproductive potential should agree to
             use an effective means of birth control and contraception should continue for three
             months after the last dose of imatinib mesylate (Gleevec) to allow complete clearance
             of drug and its principle metabolites from the body; in women of childbearing
             potential, a pregnancy test will be required at study entry