Leukemia Clinical Trial
Official title:
AUTOLOGOUS STEM CELL TRANSPLANTATION FOR ACUTE MYELOID LEUKEMIA IN SECOND REMISSION: A PHASE II STUDY
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining chemotherapy with peripheral stem cell
transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill
more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation
following chemotherapy in treating patients with acute myeloid leukemia in second remission.
Status | Completed |
Enrollment | 51 |
Est. completion date | March 2009 |
Est. primary completion date | February 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years to 69 Years |
Eligibility |
DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia (AML) in second complete
remission (CR) for 30 days to less than 1 year before study entry Second CR defined by the
following: Neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Normal
bone marrow morphology with no excess blasts (greater than 5%) No myelodysplasia No
extramedullary or CNS leukemia Initial diagnosis of de novo AML (M0-M7) No prior
myelodysplasia No myeloproliferative disease No secondary AML Cytogenetics not required No
cytogenetic evidence of persistent leukemia if cytogenetics performed PATIENT CHARACTERISTICS: Age: 15 to 69 Hematopoietic: See Disease Characteristics Granulocyte count at least 1,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 3 times normal Alkaline phosphatase less than 3 times normal No cirrhosis or chronic hepatitis Biopsy required if chronic liver disease suspected (history of alcohol abuse or possible hepatitis) Renal: Creatinine less than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow/stem cell transplantation Chemotherapy: Prior non-ablative chemotherapy at initial diagnosis, during initial remission, or as reinduction therapy (to produce current second remission) allowed At least 4 weeks since hospital discharge after reinduction therapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior post-remission therapy for second remission |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland |
United States | St. Joseph's Hospital and Medical Center | Paterson | New Jersey |
United States | UCSF Cancer Center and Cancer Research Institute | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
Linker CA, Owzar K, Powell B, Hurd D, Damon LE, Archer LE, Larson RA; Cancer and Leukemia Group B. Auto-SCT for AML in second remission: CALGB study 9620. Bone Marrow Transplant. 2009 Sep;44(6):353-9. doi: 10.1038/bmt.2009.36. Epub 2009 Mar 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease free survival | 2 years | No |
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