ALFA 0703 : A Randomized Multicenter Phase III Study to Evaluate the Role of All-trans Retinoic Acid (ATRA) in Combination with Chemotherapy or azacitidine as salvage therapy and Azacitidine as Maintenance Therapy in Older Patients with Acute Myeloblastic Leukemia (AML) - ALFA 0703

• Conditions: Older patients with acute myeloblastic leukemia (AML).; MedDRA version: 8.1Level: PTClassification code 10000878Term: LAM

• Registration Number: EUCTR2006-005562-39-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Aged of 65 to 79 years
- With a morphologically proven diagnosis of AML according to WHO classification either de novo or post -MDS
- Not previously treated for AML
- Signed informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- APL in the WHO classification.
- Ph1-positive AML or prior Ph1-positive disease
- AML evolving from a prior MPS in the WHO classification.
- Prior treatment with chemotherapy or radiotherapy for another tumor
- Prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma
- Prior advanced malignant hepatic tumor
- ECOG Performance Status Score > 2.
- Known Poor-risk cytogenetics, including monosomy 7, abnormalities of both chromosomes 5 and 7, 3q abnormality, and complex karyotype (5 anomalies or more).
- 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.
- Total serum bilirubin more than 2x's the ULN at the laboratory where the analysis was - performed, except if AML-related.
- AST (SGOT) or ALT (SGPT) more than 2.5x's the ULN at the laboratory where the analysis was performed, except if AML-related
- LVEF less than.55 or equivalent by doppler echocardiography
- Known intolerance to Azacitidine, mannitol, retinoids, pegfilgrastim
- Positive serum test for HIV and HTLV-1
- NYHA Grade 3/4 cardiac disease .
- Severe infection at inclusion time
- Psychiatric disease or an history of non-compliance to medical regimens or patients considered potentially unreliable.
- Absence of health care insurance (affiliation à un régime de Sécurité Sociale)
- Participation to any study requiring informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified