NCT00039377

Chemotherapy, Imatinib Mesylate, and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Official Title:

A Phase II Trial of Sequential Chemotherapy, Imatinib Mesylate (Gleevec, STI571) (NSC # 716051), and Transplantation for Adults With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by the CALGB and SWOG

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

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

Disease(s) and\or Condition(s)

Adult Acute Lymphoblastic Leukemia in Remission

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: imatinib mesylate
    • Description: Given PO
    • Arm Group Labels: Treatment (imatinib mesylate, chemotherapy, PBSCT)
    • Type: DRUG
    • Name: methotrexate
    • Description: Given IT and IV
    • Arm Group Labels: Treatment (imatinib mesylate, chemotherapy, PBSCT)
    • Type: DRUG
    • Name: vincristine sulfate
    • Description: Given IV
    • Arm Group Labels: Treatment (imatinib mesylate, chemotherapy, PBSCT)
    • Type: DRUG
    • Name: leucovorin calcium
    • Description: Given IV and PO
    • Arm Group Labels: Treatment (imatinib mesylate, chemotherapy, PBSCT)
    • Type: PROCEDURE
    • Name: peripheral blood stem cell transplantation
    • Description: Undergo PBSCT
    • Arm Group Labels: Treatment (imatinib mesylate, chemotherapy, PBSCT)
    • Type: PROCEDURE
    • Name: autologous hematopoietic stem cell transplantation
    • Description: Undergo autologous PBSCT
    • Arm Group Labels: Treatment (imatinib mesylate, chemotherapy, PBSCT)
    • Type: PROCEDURE
    • Name: allogeneic hematopoietic stem cell transplantation
    • Description: Undergo allogeneic PBSCT
    • Arm Group Labels: Treatment (imatinib mesylate, chemotherapy, PBSCT)
    • Type: RADIATION
    • Name: total-body irradiation
    • Description: Undergo TBI
    • Arm Group Labels: Treatment (imatinib mesylate, chemotherapy, PBSCT)
    • Type: DRUG
    • Name: tacrolimus
    • Description: Given IV or PO
    • Arm Group Labels: Treatment (imatinib mesylate, chemotherapy, PBSCT)
    • Type: BIOLOGICAL
    • Name: filgrastim
    • Description: Given SC
    • Arm Group Labels: Treatment (imatinib mesylate, chemotherapy, PBSCT)
    • Type: DRUG
    • Name: etoposide
    • Description: Given IV
    • Arm Group Labels: Treatment (imatinib mesylate, chemotherapy, PBSCT)
    • Type: DRUG
    • Name: cyclophosphamide
    • Description: Given IV
    • Arm Group Labels: Treatment (imatinib mesylate, chemotherapy, PBSCT)
    • Type: DRUG
    • Name: cytarabine
    • Description: Given IV
    • Arm Group Labels: Treatment (imatinib mesylate, chemotherapy, PBSCT)
    • Type: OTHER
    • Name: laboratory biomarker analysis
    • Description: Correlative studies
    • Arm Group Labels: Treatment (imatinib mesylate, chemotherapy, PBSCT)
Sponsor
  • National Cancer Institute (NCI)