A phase II, multi-center, open-label, repeat-dose study of Lenalidomide (Revlimid ®) plus low-dose Dexamethasone in patients with refractory B-cell lineage acute lymphoblastic leukemia or in relapse after two lines of treatment(RV-405 LAL) - RV-405 LA

Institut de Cancérologie de la Loire0 个研究点开始时间: 2009年9月10日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Documented B-cell lineage ALL (non-Ph+), which under WHO guidelines is now referred to as precursor B-lymphoblastic leukemia/lymphoma.
•Must have failed to at least two treatments regimens for B-lineage ALL. The inclusion of a patient can be allowed after contacting the principal investigator. Similarly, the inclusion of a patient with Ph+ ALL can be possible or must be refractory to chemotherapy. The inclusion of a patient with Ph+ All can be possible after contacting the principal investigator in presence of a T315I mutation and absence of investigational trial targeting this abnormality.
•Performance status of ? 2 by ECOG criteria.
•Any age ? 18 years is allowed.
•Life expectancy of at least 3 months.
•Adequate liver function (AST and/or ALT not > 3 times upper limits of normal).
•Adequate kidney function (calculated creatinine clearance > 50 ml/min).
•Signed informed consent prior to start of any study-specific procedures
•* Negative Pregnancy test performed in the 3 days prior to the study
•* Effective contraception without interruption for female subject of childbearing potential
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•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

•Active serious infection not controlled by oral or intravenous antibiotics.
•Treatment with any investigational antileukemic agent or chemotherapy agent in at least 7 days prior to study entry and lack of full recovery from side effects due to prior therapy independent of when that therapy was given.
•Rapidly progressive disease with compromised organ function judged to be life-threatening by the Investigator.
•Patients with clinical evidence of active CNS disease.
•Pregnant and/or lactating female.
•Patients with known HIV infection.
•Patients with known active hepatitis B and/or hepatitis C infection.
•Hypersensitive or intolerant to any component of the study drug formulation.

发起方

Institut de Cancérologie de la Loire