Phase II study evaluating the efficacy of Lenalidomide in association with Rituximab in refractory or relapse of primary central nervous system lymphoma
- Conditions
- Primary central nervous system or Intra ocular lymphoma in relapse or refractory to previous treatmentMedDRA version: 14.1Level: LLTClassification code 10051811Term: Cerebral lymphomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2012-003786-17-FR
- Lead Sponsor
- INSTITUT CURIE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
1. Patients over 18 years old with a refractory or relapse PCNSL and who have previously received at least high dose methotrexate (> 1.5 g/m²) and high dose cytarabine (2 g/m²).
2. Patients can have received radiotherapy or intensive chemotherapy with hematopoietic stem cell rescue as part of treatment of the PCNSL or IOL
3. Patients over 18 years old with a refractory or relapse IOL and who have received either intravenous high dose methotrexate (> 1.5 g/m2) or intraocular methotrexate
4. Life expectancy > 2 months
5. Able to swallow capsules (stomach tube not allowed)
6. Adequate bone marrow function with absolute leukocytes > 2000/mm3, neutrophil count (ANC) > 1000/mm3, haemoglobin > 8 g/dl and platelets > 100 000/mm3
7. Calculated creatinine clearance > 40 ml/min. Patients with calculated creatinine clearance between 40 and 50ml/min lenalidomide dose will be adjusted as follows (10mg once daily)
8. Patient aged 18 years old or more and without measure of legal protection
9. Able to understand teratogenic risks of the treatment
10. Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study and for at least 4 weeks after discontinuation of all study treatments The pregnancy test (ßHCG amount) must be negative at the inclusion and during the study. Men must agree not to procreate a child and use condoms if their partner can procreate, during all the treatment period.
11. Signed inform consent
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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
1.Contraindication to any drug contained in the chemotherapy regimen or to any of their excipients
2.T-cell lymphoma
3.Diagnosis of any second malignancy within the last 5 years
4.Prior history of organ transplantation or other cause of severe immunodeficiency
5.Known HIV or HTLV-1 infection, positive serology to HB surface antigen [HBsAg] or total HB core antibody [anti-HB-c]) and Hepatitis C (Hepatitis C virus [HCV] antibody)
6.Inclusion in another experimental anti-cancer drug therapy
7.Impossibility to follow the calendar of exams because of geographic, social or psychological reasons
8.Patient under guardianship
9.No social security
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this phase II study is to assess the efficacy of lenalidomide in combination with rituximab in relapsed/refractory PCNSL as measured by the objective response rate (CR + Cru + PR) at the end of the 8 cycles of induction therapy. Therapeutic responses will be evaluated according to the IPCG recommendations;Secondary Objective: -Tolerance and toxicity<br>-Duration of response<br>-PFS at one year<br>-Overall survival<br>-Quality of life<br>;Primary end point(s): Objective response rate (CR + CRu + PR) at the end of the induction treatment according to the international study group for PCNSL (IPCG) criteria.<br>;Timepoint(s) of evaluation of this end point: At the end of the induction treatment (nine months)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -The safety of the association during induction and maintenance therapy in a population of PCNSL (NCI V4)<br>-The duration of response<br>-PFS at one year from the date of inclusion to the date of progression of the disease or death<br>-OS from the date of inclusion to the date of death<br>-Quality of life using QLQ-C30 EORTC;Timepoint(s) of evaluation of this end point: -Tolerance and toxicity during induction and maintenance therapy<br>-Duration of response<br>-PFS at one year<br>-Overall survival (date of death)<br>-Quality of life at the end of induction and maintenance therapy<br>