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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-074-03
Enrollment
420
Registered
2004-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intermittent ATRA + 6-Mercaptopurine + Methotrexate. Type of group
Intermittent ATRA + 6-Mercaptopurine + Methotrexate. Group name:ATRA flashing only Type of group
ATRA flashing only

Sponsors

EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Early recruitment by gender and ethnicity have been updated to reflect the new recruitment goals.

Exclusion criteria

Exclusion criteria: not contemplated

Design outcomes

Primary

MeasureTime frame
Outcome name:Free event survival. 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 Timepoints:24 months—

Secondary

MeasureTime frame
Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated—

Countries

Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)