Efficacy of Lenalidomide With Rituximab in Refractory or Relapse of Primary Central Nervous Syste… (NCT01956695) | Clinical Trial Compass
CompletedPhase 2
Efficacy of Lenalidomide With Rituximab in Refractory or Relapse of Primary Central Nervous System Lymphoma
France45 participantsStarted 2013-09-18
Plain-language summary
Because Primary Central Nervous System Lymphoma (PCNSL) are mainly diffuse large B-cell lymphoma of the activated B cells (ABC) type, the investigators hypothesize that the synergy of lenalidomide with rituximab shown in systemic non-Hodgkin's lymphoma (NHL) could be observed in PCNSL.
This study will assess the efficiency of the the combination of lenalidomide and rituximab in relapsed/refractory PCNSL, and the efficiency of a maintenance treatment with lenalidomide alone in maintaining the response.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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).
✓. Patients can have received radiotherapy or intensive chemotherapy with hematopoietic stem cell rescue as part of treatment of the PCNSL or IOL
✓. 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
✓. Life expectancy \> 2 months
✓. Able to swallow capsules (stomach tube not allowed)
✓. Adequate bone marrow function with absolute leukocytes \> 2000/mm3, neutrophil count (ANC) \> 1000/mm3, haemoglobin \> 8 g/dl and platelets \> 100 000/mm3
✓. Adequate liver function with Serum SGOT/AST or SGPT/ALT \< 3.0 X Upper Limit of Normal ULN ; bilirubin \< 1.5 X LNS (excepted in case of hemolytic anemia or Gilbert's syndrome)
✓. 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)
Exclusion criteria
✕. Contraindication to any drug contained in the chemotherapy regimen or to any of their excipients
✕. T-cell lymphoma
✕. Diagnosis of any second malignancy within the last 5 years
What they're measuring
1
Assess the efficacy of lenalidomide in combination with rituximab in relapsed/refractory PCNSL as measured by the objective response rate (CR + uCR + PR) at the end of the 8 cycles of induction therapy.
✕. Prior history of organ transplantation or other cause of severe immunodeficiency
✕. History of heart disease and/or impaired cardiac function (ECG QTc\>450msec, congenital long QT syndrome, history of ventricular tachyarrhythmia, ventricular fibrillation, congestive heart failure NYHA III/IV, uncontrolled hypertension).
✕. 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) not older than 4 weeks
✕. Inclusion in another experimental anti-cancer drug therapy\*
✕. Impossibility to follow the calendar of exams because of geographic, social or psychological reasons