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

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点开始时间: 2008年6月27日最近更新: 2012年3月19日

试验速览

暂无简介。

•- 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

•- 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

发起方