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
- Conditions
- Treatment for B-cell Acute lymphoblastic leukemia in relapse.
- Registration Number
- EUCTR2009-009372-13-FR
- Lead Sponsor
- Institut de Cancérologie de la Loire
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method