A Phase 3 interventional study of GM-CSF in Acute Myeloid Leukemia, sponsored by Acute Leukemia French Association. Completed. Open to participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2009-04-13.
Sponsored by Acute Leukemia French Association · Phase 3, Interventional, and Treatment
The purpose of this study is:
Patients aged 15-50 are enrolled and randomly assigned to receive GM-CSF or no GM-CSF during all remission-induction and consolidation courses of chemotherapy. Induction chemotherapy consists of a timed-sequential chemotherapy including a first sequence of chemotherapy combining daunorubicin, 80 mg/m2 per day, administered IV as a short infusion over 3 days (days 1-3), and cytarabine, 500 mg/m2 per day IV as a continuous infusion over the same period. The second sequence, administered after 4-day free interval, consists of mitoxantrone, 12 mg/m2 per day, administered IV as a short infusion over 2 days (days 8 and 9), and cytarabine, 500 mg/m2/12h, administered as a 3-hour infusion for 3 days (days 8-10). Salvage therapy consists of cytarabine, 3 g/m2/12h on days 1,3,5,7, combined with amsacrine, 100mg/m2 per day on days 1 to 3. GM-CSF (Leucomax, recombinant human GM-CSF from Escherichia Coli, Schering Plough, Kenilworth,N.J., USA) is given at a dose of 5µg/kg per day, intravenously beginning at day 1 of each chemotherapy course and continuing until the last day of chemotherapy of each course.
Patients who achieve CR after induction chemotherapy or salvage therapy are randomly assigned to consolidation courses consisting of either a timed sequential chemotherapy similar to that of the ALFA-9000 trial (P2 arm) or the CALGB postremission chemotherapy (P1 arm), which includes 4 cycles of high-dose cytarabine, followed by 4 additional maintenance courses.
5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.
This study's enrollment of 473 is above the median of 38 across 4,248 interventional studies indexed under Leukemia.
Browse Leukemia studies →Acute Leukemia French Association is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
* Daunorubicine (CérubidineR) : 80 mg/m2/jour IV over 30 min from day 1 to day 3, * AraC (AracytineR) : 500 mg/m2/jour IV from day 1 to day 3, * Mitoxantrone (NovantroneR) : 12 mg/m2/jour IV over 30 min from day 8 to 9 * AraC (AracytineR) : 500 mg/m2/12h IV over 3 hours from day 8 to day10. * GM-CSF (LeucomaxR): 5 µg/kg/jour IV over 6 hours from day 1 to day 10.
Drug: GM-CSF
* Daunorubicine (CérubidineR) : 80 mg/m2/jour IV over 30 min from day 1 to day 3, * AraC (AracytineR) : 500 mg/m2/jour IV from day 1 to day 3, * Mitoxantrone (NovantroneR) : 12 mg/m2/jour IV over 30 min from day 8 to 9 * AraC (AracytineR) : 500 mg/m2/12h IV over 3 hours from day 8 to day10.
Drug: GM-CSF
* AraC (Aracytine) : 3 g/m2/12h IV (3 hours) on days 1, 3 , 5 * GM-CSF :5 µg/kg/d IV (6 hours) from day1 to day 5
Drug: GM-CSF
- AraC (Aracytine) : 3 g/m2/12h IV (3 hours) on days 1, 3 , 5
Drug: GM-CSF
Randomization 1: GM-CSF (5micogram/Kg/d) versus no GM-CSF during induction chemotherapy and all consolidation courses. Randomiization 2: Consolidation high dose AraC versus consolidation EMA
Also known as: GM-CSF: molgramostim, AraC: Cytarabine, Daunorubicine: Cerubidine, EMA: etoposide, mitoxantrone, cytarabine
Assessing the potential value of the daily administration of GM-CSF during induction chemotherapy and post-induction for analyzing and comparing the arms with and without GM-CSF: EFS, % of CR, duration of remission, OS and toxicity of each treatment.
Time frame: 72 months
Evaluate the effectiveness on DFS of a single course of consolidation using a very intensive sequential chemotherapy with mitoxantrone, AraC and etoposide feasible compared to 4 courses of high dose AraC followed of 4 courses of maintenance.
Time frame: 72 months
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This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.
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Acute Leukemia French Association