APL93: Timing of CxT and Role of Maintenance
Assessment of the Optimal Timing of Chemotherapy With or After ATRA and the Role of Maintenance
1 other identifier
interventional
576
0 countries
N/A
Brief Summary
Objectives of the trial were to assess the optimal timing of chemotherapy with or after ATRA and the role of maintenance therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 1993
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1993
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 1998
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 1998
CompletedFirst Submitted
Initial submission to the registry
December 27, 2007
CompletedFirst Posted
Study publicly available on registry
January 24, 2008
CompletedJanuary 24, 2008
December 1, 2007
5.9 years
December 27, 2007
January 23, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
For induction treatment event-free survival (EFS), calculated from the date of randomization, was the major endpoint.
2 years
Study Arms (7)
ATRA ->Chemo
NO INTERVENTIONPatients 65 years of age with a WBC count less than 5,000 were randomized to receive the reference ATRA treatment of our previous trial (APL91 trial), ie, 45 mg/m2/d ATRA followed by CT or ATRA plus CT (ATRA+CT). In the ATRA followed byCT group, patients received 45 mg/m2/d ATRA orally until CR, with a maximum of 90 days. After CR achievement, they received a course of 60 mg/m2/d daunorubicin (DNR) for 3 days and 200 mg/m2/d AraC for 7 days (course I). However, course I was added to ATRA if the WBC count was increased to greater than 6,000, 10,000, or 15,000 by day 5, 10, and 15 of ATRA treatment, respectively, because, from our experience, patients were at risk of ATRA syndrome above those thresholds.
ATRA+CT
EXPERIMENTALPatients randomized to the ATRA+CT group received the same combination of ATRA and CT, with course I of CT starting on day 3 of ATRA treatment. This 48-hour interval before onset of CT was based on our previous report, because it allowed correction of coagulopathy.
High WBC
NO INTERVENTIONPatients with a WBC count greater than 5,000 at presentation (irrespective of their age) and patients 66 to 75 years of age with a WBC count 5,000 were not randomized but received ATRA plus CT course I from day 1 (high WBC group) and the same schedule as in the ATRA-\>CT group (elderly group), respectively.
no maintenance
NO INTERVENTIONNo maintenance
maintenance ATRA
EXPERIMENTALIntermitent ATRA as maintenance
maintenance Cxt
EXPERIMENTALcontinuous CT with 6 mercaptopurine (90 mg/m2/d, orally) and methotrexate (15 mg/m2/wk, orally) as maintenance
maintenance both
EXPERIMENTALcontinuous CT with 6 mercaptopurine (90 mg/m2/d, orally) and methotrexate (15 mg/m2/wk, orally) AND ATRA as maintenance
Interventions
patients were randomized both to receive or not receive intermittent ATRA (45 mg/m2/d, 15 days every 3 months) and to receive or not receive continuous CT with 6 mercaptopurine (90 mg/m2/d, orally) and methotrexate (15 mg/m2/wk, orally), according to a 2-by-2 factorial design stratified on the initial induction treatment group
Eligibility Criteria
You may qualify if:
- Diagnosis of APL, based on morphology criteria
- Age 75 years or less; and
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 10438706RESULTAdes 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.
PMID: 20018913DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
pierre fenaux, mD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 27, 2007
First Posted
January 24, 2008
Study Start
January 1, 1993
Primary Completion
December 1, 1998
Study Completion
December 1, 1998
Last Updated
January 24, 2008
Record last verified: 2007-12