RANDOMIZED PHASE III STUDY OF TRETINOIN CONCURRENT WITH CHEMOTHERAPY WITH OR WITHOUT ARSENIC TRIOXIDE (AS203) (NSC 706363) AS INITIAL CONSOLIDATION THERAPY FOLLOWED BY MAINTENANCE THERAPY WITH INTERMITTENT TRETINOIN MORE MERCAPTOPURINE AND MET
Not Applicable
- Conditions
- -C924 Acute promyelocytic leukaemia [PML]Acute promyelocytic leukaemia [PML]C924
- Registration Number
- PER-074-03
- Lead Sponsor
- EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Early recruitment by gender and ethnicity have been updated to reflect the new recruitment goals.
Exclusion Criteria
not contemplated
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Free event survival.<br>Measure:The efficacy (event-free survival) and toxicity of 2 induction / consolidation therapies in patients not treated with acute promyelocytic leukemia with ATRA / ARA-C / Daunorubicin with or without arsenic trioxide<br>Timepoints:24 months<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:not contemplated<br><br>Measure:not contemplated<br><br>Timepoints:not contemplated<br>