DNR and AraC Combined to Fractionated Mylotarg® in Patients With First Relapse of AML (MYLOFRANCE2)
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|ClinicalTrials.gov Identifier: NCT02182596|
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: Mylotarg||Phase 1 Phase 2|
Induction course are:
GO 3mg/m2 on days 1, 4,7 + the three dose levels were as follows:
level 1: DNR: 45 mg/m2 x 3 days + AraC: 100 mg/m2 x 7 days level 2: DNR: 60 mg/m2 x 3 days + AraC: 100 mg/m2 x 7 days level 3: DNR 60 mg/m2 x 3 days + AraC: 200 mg/m2 x 7 days. with 20 mg of methylprednisolone prior to each GO infusion. Consolidation course: patients in CR may receive 2 additional courses of consolidation chemotherapy with Amsacrine 90 mg/m2 daily for 3 days, and Ara-C (1g/m2/12 hours x 3 days) + GO 3 mg/m2 on day 1.
Treatment with HSCT is offered at the discretion of the physician in charge of the patient. A delay between last infusion of GO and HSCT above 3 months is recommended
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Dose-finding Phase I/II Trial of Daunorubicin and Cytarabine Combined to Fractionated Mylotarg® as Re-induction Treatment in Patients With First Relapse of Acute Myeloid Leukemia|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||January 2011|
Experimental: DAUNORUBICINE - ARACYTINE - MYLOTARG -
Adaptive Bayesian method for dose-finding in phase I/II clinical trials based on treatment efficacy and toxicity (Thall, Russel, 1998), with successive patients cohorts and three combined dose levels:
DNR 45 mg/m2 IV days 1 to 3 + AraC 100 mg/m2 CI days 1 to 7 + Mylotarg 3mg/m2 IV days 1, 4, 7.
DNR 60 mg/m2 IV days 1 to 3 + AraC 100 mg/m2 CI days 1 to 7 + Mylotarg 3mg/m2 IV days 1, 4, 7.
DNR 60 mg/m2 IV days 1 to 3 + AraC 200 mg/m2 CI days 1 to 7 + Mylotarg 3mg/m2 IV days 1, 4, 7.
Two consolidation courses for CR patients:
Amsacrine: 90 mg/m2 IV Day 1 Cytarabine: 1g/m2 twice a day IV Days 1 to 4 Mylotarg: 3 mg/m2 IV Day 1.
Dose level study
Other Name: Gemtuzumab Ozogamicin
- Dose-limiting toxicity (DLT) defined by the occurrence of any G3 or G4 non reversible toxicity at day 45 excluding myelosuppression or infection due to neutropenia, and response defined by complete remission at day 45 [ Time Frame: Day 45 post first dose of treatment ]
- Secondary endpoint: Duration of second remission in AML patients treated for relapse with chemotherapy + Mylotarg as re-induction and consolidation. [ Time Frame: At two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02182596
|Caen, France, 14033|
|Clamart, France, 92141|
|Creteil, France, 94010|
|Lille, France, 59037|
|Limoges, France, 87042|
|Hopital Edouard Herriot|
|Meaux, France, 77104|
|St Antoine Hospital|
|Paris, France, 75012|
|Roubaix, France, 59100|
|Rouen, France, 76038|
|Villejuif, France, 94805|
|Principal Investigator:||CASTAIGNE SYLVIE, PROFESSOR||Acute Leukemia French Association|