Phase 2
N=57
Chemotherapy, Imatinib Mesylate, and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Bottom Line
View on ClinicalTrials.gov: NCT00039377 ↗Enrolled (actual)
57
Serious AEs
31.6%
Results posted
Mar 2014
Primary outcome: Primary: Disease Free Survival — 1.7 years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- imatinib mesylate (Drug); methotrexate (Drug); vincristine sulfate (Drug); leucovorin calcium (Drug); peripheral blood stem cell transplantation (Procedure); autologous hematopoietic stem cell transplantation (Procedure); allogeneic hematopoietic stem cell transplantation (Procedure); total-body irradiation (Radiation); tacrolimus (Drug); filgrastim (Biological); etoposide (Drug); cyclophosphamide (Drug); cytarabine (Drug); laboratory biomarker analysis (Other)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Free Survival |
1.7 | — |
| SECONDARY Overall Survival |
3.6 | — |
| SECONDARY Number of Participants Who Achieved a BCR-ABL Response at 12 Months |
9; 4 | — |
| SECONDARY 5 Year Disease-free Survival for Autologous & Allogeneic Transplant Groups |
46; 47 | — |
| SECONDARY 5 Year Overall Survival for Autologous & Allogeneic Transplant Groups |
53; 51 | — |
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
Data sourced from ClinicalTrials.gov (NCT00039377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.