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ALFA-0703 Study in Older Patients With Acute Myeloblastic Leukemia (AML)

Information source: Acute Leukemia French Association
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myeloid Leukemia

Intervention: Vesanoid (ATRA) (Drug); AZACITIDINE (VIDAZA) (Drug); CYTARABINE (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: Acute Leukemia French Association

Official(s) and/or principal investigator(s):
GARDIN CLAUDE, MD, Principal Investigator, Affiliation: Acute Leukemia French Association


A Randomized Multicenter Phase III Study to Evaluate the Role of All-trans Retinoic Acid (ATRA) in Combination with Induction Chemotherapy, or Azacitidine and Idarubicin as salvage therapy and Idarubicin with Cytarabine or Azacitidine as Maintenance Therapy in Older Patients with Acute Myeloblastic Leukemia (AML). To compare the outcome of elderly patients with newly-diagnosed AML treated with standard induction chemotherapy and post-remission therapy, in only patients in CR, with either azacitidine or cytarabine combined to idarubicin +/- ATRA and salvage therapy with azacitidine combined to idarubicin +/- ATRA.

Clinical Details

Official title: A Randomized Multicenter Phase III Study to Evaluate the Role of All-trans Retinoic Acid (ATRA) in Combination With Induction Chemotherapy, or Azacitidine and Idarubicin as Salvage Therapy and Idarubicin With Cytarabine or Azacitidine as Maintenance Therapy in Older Patients With Acute Myeloblastic Leukemia (AML)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

For randomization R1, the primary endpoint is Event-free Survival (EFS)

For randomization R2, the primary endpoint is disease free survival (DFS)

Secondary outcome:

Complete Response (CR) rate

Overall survival

Response rate to azacitidine idarubicin +/-ATRA combination after intensive chemotherapy failure and identification of possible predictors of response to this therapy

Assess the safety of combination ATRA + chemotherapy or idarubicin-azacitidine courses and of maintenance with azacitidine

Effects on relapse rates of ATRA and maintenance, with respect to cytogenetics risk groups, subtypes of AML and mutational status (FLT3, MLL), and biomarkers

Detailed description: Induction therapy : First randomization (R1) at baseline : ATRA versus no ATRA. Salvage therapy : No conventional salvage therapy is planned. Patients who will not achieve CR, according to IWG criteria after induction will be treated with 3 courses of azacitidine and idarubicin +/- ATRA combination, if eligible for further treatment. Followed by 3 identical courses and 6 courses of maintenance by azacitidine alone to be delivered every 28 days, in those patients reaching CR or PR after 3 courses (evaluation of response from 28 to 56 days from course 3). Randomization R2: type of maintenance: Response to induction will be evaluated 2 weeks after myeloid recovery, just before first consolidation course, due use of to pegfilgrastim, lenograstim or filgrastim during induction. Responses will be classified according to the Revised Recommendations of the IWG for AML. Patients in CR only will be subjected to a second randomization R2 as follows 6 courses of combined chemotherapy, will be delivered as outpatients, ATRA according to R1 randomization.


Minimum age: 65 Years. Maximum age: 79 Years. Gender(s): Both.


Inclusion Criteria: 1. Aged of 65 to 79 years 2. With a morphologically proven diagnosis of AML according to WHO classification either de novo or AML with "myelodysplasia related changes" 3. Not previously treated for AML 4. Signed informed consent. Exclusion Criteria: 1. APL in the WHO classification. 2. Ph1-positive AML or prior Ph1-positive disease 3. AML evolving from a prior MPN in the WHO 2008 classification. 4. Prior treatment with chemotherapy or radiotherapy for another tumor 5. Prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma 6. Prior advanced malignant hepatic tumor 7. ECOG Performance Status Score > 2 8. Creatinine level more than 2x's the upper limit of the normal range (ULN) at the laboratory where the analysis was performed, except if AML-related. 9. Total serum bilirubin more than 2x's the ULN at the laboratory where the analysis was performed, except if AML-related. 10. AST (SGOT) or ALT (SGPT) more than 2. 5x's the ULN at the laboratory where the analysis was performed, except if AML-related 11. LVEF less than. 55 or equivalent by doppler echocardiography 12. Known intolerance to Azacitidine, mannitol, retinoids 13. Positive serum test for HIV and HTLV-1 14. NYHA Grade 3/4 cardiac disease . 15. Severe infection at inclusion time. 16. Psychiatric disease or an history of non-compliance to medical regimens or patients considered potentially unreliable. 17. Absence of health care insurance (affiliation à un régime de Sécurité Sociale) 18. Participation to any study requiring informed consent

Locations and Contacts

Chu Amiens Sud, Amiens 80054, France

CH, Argenteuil 95107, France

Hopital Avicenne, Bobigny, France

Chu Boulogne Sur Mer, Boulogne Sur Mer 62321, France

CH, Caen 14033, France

Hopital Percy, Clamart 92141, France

Ch Sud Francilien, Corbeil Essonnes 94010, France

Hopital Henri Mondor, Creteil, France

Ch Dunkerque, Dunkerque 59385, France

CH, Lens 62307, France

CHU, Lille 59037, France

CH, Limoges 87042, France

Hopital Edouard Herriot, Lyon, France

CH, Meaux 77104, France

Centre Antoine Lacassagne, Nice 06189, France

Necker Hospital, Paris 15 75015, France

Hopital Pitie-Salpetriere, Paris 75651, France

Hopital Saint-Louis, Paris, France

St Antoine Hospital, Paris 75012, France

Ch Rene Dubos, Pontoise 95303, France

CH, Roubaix 59100, France

CHU, Rouen 76038, France

CNLCC, Saint-Cloud 92210, France

CH, Valenciennes 59322, France

CH, Versailles, France

IGR, Villejuif, France

Additional Information

Starting date: April 2010
Last updated: January 7, 2011

Page last updated: August 23, 2015

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