Status:
COMPLETED
Bortezomib, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Acute Myeloid Leukemia
Adult Acute Megakaryoblastic Leukemia (M7)
Eligibility:
All Genders
60-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This phase II trial studies the side effects and best dose of bortezomib when given together with daunorubicin and cytarabine and to see how well it works in treating older patients with previously un...
Detailed Description
PRIMARY OBJECTIVES: I. To define the remission induction response rate (complete response \[CR\] and CR with incomplete platelet recovery \[CRp\]) in older patients with previously untreated acute my...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Unequivocally histologically confirmed acute myeloid leukemia (AML)
- At least 20% blasts in the bone marrow based on WHO criteria
- No acute promyelocytic leukemia (M3)
- Antecedent hematologic disorder or myelodysplastic syndromes allowed provided the patient did not receive cytotoxic chemotherapy, including azacitidine and decitabine, for their pre-leukemic disorder
- Concurrent enrollment on CALGB-8461 required
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No ataxia, cranial neuropathy, or peripheral neuropathy \>= grade 2
- LVEF \>= 40% by ECHO or MUGA scan
- No signs or symptoms of congestive heart failure
- DLCO \>= 50% (corrected for hemoglobin)
- No prior therapy for leukemia or pre-leukemic disorders, except for the following:
- emergency leukapheresis;
- emergency treatment for hyperleukocytosis with hydroxyurea;
- cranial radiotherapy for CNS leukostasis (one dose only);
- growth factor/cytokine support
- No other concurrent chemotherapy, except for the following:
- I) steroids administered for adrenal failure, hypersensitivity reactions, or septic shock;
- II) hormones administered for non-disease-related conditions (e.g., insulin for diabetes or estrogens or progestins for gynecologic indications)
- No concurrent palliative radiotherapy
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00742625
Start Date
September 1 2008
End Date
December 1 2012
Last Update
September 12 2014
Active Locations (22)
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1
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
2
Lombardi Comprehensive Cancer Center at Georgetown University
Washington D.C., District of Columbia, United States, 20057
3
Florida Hospital
Orlando, Florida, United States, 32803
4
University of Chicago
Chicago, Illinois, United States, 60637