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Clinical Trials/EUCTR2012-003786-17-FR
EUCTR2012-003786-17-FR
Active, not recruiting
Phase 1

Phase II study evaluating the efficacy of Lenalidomide in association with Rituximab in refractory or relapse of primary central nervous system lymphoma (PCNSL) - Proof of concept” - REVRI

INSTITUT CURIE0 sites45 target enrollmentApril 18, 2013
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ConditionsPrimary 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]
DrugsREVLIMID 5mgREVLIMID 10 mg

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Primary central nervous system or Intra ocular lymphoma in relapse or refractory to previous treatment
Sponsor
INSTITUT CURIE
Enrollment
45
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 18, 2013
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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