At a glance
ClinicalIndex Comparison Record- ✓Unequivocal histologic diagnosis of acute lymphoblastic leukemia (ALL)
- ✓Philadelphia chromosome-positive disease confirmed by cytogenetics (t(9;22) or 3-way variant) or molecular analysis (RT-PCR or FISH)
- ✓Complete or partial remission after one course of induction chemotherapy with intensive 4-5 drug regimen on a CALGB or SWOG ALL protocol, with or without prior imatinib
- ✓Alternatively, complete or partial remission after standard induction regimen (with or without imatinib) without prior cooperative group enrollment; Ph+ positivity may be confirmed outside CALGB/SWOG laboratory
- ✕Pregnancy or nursing
- ✕Inability or unwillingness to use effective contraception for three months after final imatinib dose
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating imatinib mesylate, methotrexate, and 12 other interventions for Adult Acute Lymphoblastic Leukemia in Remission. Completed, enrolled 58 participants across 97 sites.
Detailed 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.
Study Details
Timeline
Interventions
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