Chemotherapy, Imatinib Mesylate, and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Launched by NATIONAL CANCER INSTITUTE (NCI) · Jan 26, 2003
Trial Information
Current as of May 22, 2025
Completed
Keywords
ClinConnect Summary
PRIMARY OBJECTIVES:
I. Determine the activity of imatinib mesylate (Gleevec) to prolong disease-free survival (DFS) and overall survival in acute lymphoblastic leukemia (ALL) patients with t(9;22).
II. Determine the ability of imatinib mesylate (Gleevec) to produce or maintain a BCR-ABL-negative status, as judged by real-time-polymerase chain reaction (RT-PCR) following sequential chemotherapy, imatinib mesylate (Gleevec) and transplantation.
III. Determine the feasibility of collecting adequate peripheral blood stem cells for autologous transplantation following imatinib mesylate (Gleev...
Gender
ALL
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
About National Cancer Institute (Nci)
The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Charleston, South Carolina, United States
Chicago, Illinois, United States
Saint Louis, Missouri, United States
Buffalo, New York, United States
Maywood, Illinois, United States
Manhasset, New York, United States
Bangor, Maine, United States
Wichita, Kansas, United States
Great Falls, Montana, United States
New Hyde Park, New York, United States
Chanute, Kansas, United States
Dodge City, Kansas, United States
Newton, Kansas, United States
Wellington, Kansas, United States
Winfield, Kansas, United States
Billings, Montana, United States
Bozeman, Montana, United States
Kalispell, Montana, United States
Kalispell, Montana, United States
Sheridan, Wyoming, United States
Columbus, Ohio, United States
Carthage, Illinois, United States
Galesburg, Illinois, United States
Havana, Illinois, United States
Macomb, Illinois, United States
Normal, Illinois, United States
Peoria, Illinois, United States
Princeton, Illinois, United States
Salina, Kansas, United States
Oswego, New York, United States
Eureka, Illinois, United States
Salina, Kansas, United States
Canton, Illinois, United States
Pekin, Illinois, United States
Peoria, Illinois, United States
Lawrence, Kansas, United States
Liberty, Missouri, United States
Bozeman, Montana, United States
Missoula, Montana, United States
Rochester, New York, United States
Syracuse, New York, United States
Winston Salem, North Carolina, United States
Kansas City, Kansas, United States
New York, New York, United States
Rochester, New York, United States
Chicago, Illinois, United States
Atlanta, Georgia, United States
Bloomington, Illinois, United States
Chicago, Illinois, United States
Galesburg, Illinois, United States
Hopedale, Illinois, United States
Normal, Illinois, United States
Ottawa, Illinois, United States
Ottawa, Illinois, United States
Pekin, Illinois, United States
Peoria, Illinois, United States
Peoria, Illinois, United States
Peoria, Illinois, United States
Peru, Illinois, United States
Spring Valley, Illinois, United States
Fort Wayne, Indiana, United States
El Dorado, Kansas, United States
Kingman, Kansas, United States
Olathe, Kansas, United States
Overland Park, Kansas, United States
Parsons, Kansas, United States
Pratt, Kansas, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Beverly, Massachusetts, United States
Gloucester, Massachusetts, United States
Worcester, Massachusetts, United States
Independence, Missouri, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
Billings, Montana, United States
Billings, Montana, United States
Billings, Montana, United States
Billings, Montana, United States
Billings, Montana, United States
Bozeman, Montana, United States
Butte, Montana, United States
Great Falls, Montana, United States
Helena, Montana, United States
Kalispell, Montana, United States
Missoula, Montana, United States
Missoula, Montana, United States
Missoula, Montana, United States
Keene, New Hampshire, United States
Rochester, New Hampshire, United States
Manhasset, New York, United States
New Hyde Park, New York, United States
Kinston, North Carolina, United States
Pittsburgh, Pennsylvania, United States
St. Johnsbury, Vermont, United States
Richmond, Virginia, United States
Patients applied
Trial Officials
Meir Wetzler
Principal Investigator
Cancer and Leukemia Group B
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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