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

Completed · Phase 2

Conditions studied: Adult Acute Lymphoblastic Leukemia in Remission

In brief

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.

Key facts

Study ID

NCT00039377

Run by

National Cancer Institute (NCI)

People needed

58

Starts

2002-04-01

Expected to finish

2014-02-01

Last updated by the study team

2014-11-24

Who can join

Age: 15 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Saint Joseph Medical Center — Bloomington, Illinois, United States
• Graham Hospital Association — Canton, Illinois, United States
• Memorial Hospital — Carthage, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Weiss Memorial Hospital — Chicago, Illinois, United States
• Eureka Hospital — Eureka, Illinois, United States
• Galesburg Cottage Hospital — Galesburg, Illinois, United States
• Illinois CancerCare Galesburg — Galesburg, Illinois, United States
• Mason District Hospital — Havana, Illinois, United States
• Hopedale Medical Complex - Hospital — Hopedale, Illinois, United States
• Mcdonough District Hospital — Macomb, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Bromenn Regional Medical Center — Normal, Illinois, United States
• Community Cancer Center Foundation — Normal, Illinois, United States
• Illinois CancerCare-Ottawa Clinic — Ottawa, Illinois, United States
• Ottawa Regional Hospital and Healthcare Center — Ottawa, Illinois, United States
• Pekin Cancer Treatment Center — Pekin, Illinois, United States
• Pekin Hospital — Pekin, Illinois, United States
• Methodist Medical Center of Illinois — Peoria, Illinois, United States
• Proctor Hospital — Peoria, Illinois, United States
• Illinois CancerCare-Peoria — Peoria, Illinois, United States
• Illinois Oncology Research Association CCOP — Peoria, Illinois, United States
• OSF Saint Francis Medical Center — Peoria, Illinois, United States
• Illinois Valley Hospital — Peru, Illinois, United States
• Blood and Marrow Transplant Group of Georgia — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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