Status:
COMPLETED
Combination Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
5-74 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination c...
Detailed Description
OBJECTIVES: * Determine, preliminarily, the safety of incorporating arsenic trioxide (ATO) into cytarabine and daunorubicin hydrochloride-based consolidation therapy followed by tretinoin maintenance...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of acute promyelocytic leukemia (APL) by morphologic and flow cytometric documentation (high orthogonal light scatter, lack of HLA-DR expression)
- Patients with classical APL as well as the microgranular variant (M3V) are eligible
- In cases where the diagnosis is unclear, consultation with a hematopathologist is required before enrolling the patient in the study
- Patients found to have cytogenetic abnormalities that do not produce the PML-RARα gene rearrangement will be removed from study and will not be included in data analysis
- PATIENT CHARACTERISTICS:
- Patients will not be excluded because of performance status or comorbid disease
- Premenopausal female patients must have a negative pregnancy test
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for APL except hydroxyurea
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00276601
Start Date
October 1 2004
End Date
June 1 2013
Last Update
April 17 2014
Active Locations (7)
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1
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
3
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States, 30342
4
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201