APL93: Timing of CxT and Role of Maintenance

• Status: Completed
• Trial end date: 1998-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Objectives of the trial were to assess the optimal timing of chemotherapy with or after ATRA and the role of maintenance therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe d'etude et de travail sur les leucemies aigues promyelocytaires
• Collaborator: DRC lille, France
• Treatments: 6-Mercaptopurine; Methotrexate; Tretinoin

Criteria

Inclusion Criteria:

1. Diagnosis of APL, based on morphology criteria

2. Age 75 years or less; and

3. Written informed consent. Diagnosis had to be subsequently confirmed by presence of t(15;17) or PML-RAR gene rearrangement. In the absence of t(15;17) and if no analysis of the rearrangement could be made, review of initial marrow slides by an independent morphologist was mandatory.