Treatment for B-cell Acute lymphoblastic leukemia in relapse.
Conditions
Interventions
Trade Name: Revlimid 25 mg capsules
Product Name: Lenalidomide
Pharmaceutical Form: Capsule*
Sponsors
Institut de Cancérologie de la Loire
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of lenalidomide plus low-dose dexamethasone : CR (complete response), CRp(complete response without platelet reconstitution), PR (partial response), and overall response (CR+CRp+PR);Secondary Objective: • To assess the safety of lenalidomide plus dexamethasone: adverse events (type, frequency, severity of adverse events, and relationship of adverse events to study drug). • To determine the time to response. • To determine the duration of response. • To determine the progression-free survival. • To determine the QOL: European Organization for Research and Treatment of Cancer QOL questionnaire for patients with cancer (EORTC QLQ-C30). • To determine the feasibility of SCT, in case of response, after one or more cycles of lenalidomide plus dexamethasone therapy. ;Primary end point(s): Bone marrow aspirate will be performed at the end of each cycle in order to assess response to therapy and document leukemic status. Efficacy of the lenalidomide-dexamethasone combination in inducing remissions will be assessed primarily by the calculation of three response rates: CR, CRp, and RP. 5% to ? 25% blasts, and appearance of normal progenitor cells or a bone marrow with ? 5% blasts that did not qualify for CR or CRp. | — |
Countries
France
Outcome results
None listed