drugset / Trial / NCT00599937
APL93: Timing of CxT and Role of Maintenance
Phase 3
Completed
576 enrolled
European Acute Promyelocytic Leukemia Group
DRC lille, France · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Objectives of the trial were to assess the optimal timing of chemotherapy with or after ATRA and the role of maintenance therapy.
Timeline
- Start
- 1993-01
- Primary completion
- 1998-12
- Completion
- 1998-12
Publications
- Results Fenaux P, Chastang C, Chevret S, Sanz M, Dombret H, Archimbaud E, Fey M, Rayon C, Huguet F, Sotto JJ, Gardin C, Makhoul PC, Travade P, Solary E, Fegueux N, Bordessoule D, Miguel JS, Link H, Desablens B, Stamatoullas A, Deconinck E, Maloisel F, Castaigne S, Preudhomme C, Degos L. A randomized comparison of all transretinoic acid (ATRA) followed by chemotherapy and ATRA plus chemotherapy and the role of maintenance therapy in newly diagnosed acute promyelocytic leukemia. The European APL Group. Blood. 1999 Aug 15;94(4):1192-200.
- Ades L, Guerci A, Raffoux E, Sanz M, Chevallier P, Lapusan S, Recher C, Thomas X, Rayon C, Castaigne S, Tournilhac O, de Botton S, Ifrah N, Cahn JY, Solary E, Gardin C, Fegeux N, Bordessoule D, Ferrant A, Meyer-Monard S, Vey N, Dombret H, Degos L, Chevret S, Fenaux P; European APL Group. Very long-term outcome of acute promyelocytic leukemia after treatment with all-trans retinoic acid and chemotherapy: the European APL Group experience. Blood. 2010 Mar 4;115(9):1690-6. doi: 10.1182/blood-2009-07-233387. Epub 2009 Dec 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | 90 mg/m2 | Oral |
| Subject | Methotrexate | Small molecule | 15 mg/m2 | Oral |
| Subject | Tretinoin | Small molecule | 45 mg/m2 | Oral |