Overview

This trial is active, not recruiting.

Condition primary central nervous system lymphoma
Treatments cranial radiotherapy, intensive chemotherapy and hematopoietic stem cell rescue, mtx based chemotherapy
Phase phase 2
Sponsor Institut Curie
Collaborator Ministry of Health, France
Start date October 2008
End date February 2017
Trial size 140 participants
Trial identifier NCT00863460, CRH 07/422/H, EudraCT N° 2007-005378-30

Summary

Purpose of the study :

To evaluate the antitumoral effect of two therapeutic procedures and to evaluate their respective toxicity on the CNS.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
MTX-based chemotherapy followed by WBRT
cranial radiotherapy
40 Gy
mtx based chemotherapy R-RMVP :
R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58&59 and days79&80
(Experimental)
MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue
intensive chemotherapy and hematopoietic stem cell rescue Thiotepa IV (250 mg/m²/day) day-9 day-8 day-7
intensive chemotherapy and hematopoietic stem cell rescue
mtx based chemotherapy R-RMVP :
R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58&59 and days79&80

Primary Outcomes

Measure
2-years progression-free survival in each arm
time frame: 2 years after inclusion

Secondary Outcomes

Measure
Overall response rate at the end of the procedure
time frame: at the end of procedure at 1 and 2 years
Overall survival
time frame: 2 years after inclusion
Event-free survival
time frame: 2 years after inclusion
Neurotoxicity
time frame: each years during ten years

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - Histopathologically or cytologically proven diagnostic of Primary CNS lymphoma - All histological types of non-Hodgkin's lymphoma, except MALT - Age > 18 and < 60 ans. - Negative for HIV, HCV and HBV - Written informed consent - Exclusion Criteria: - Age < 18 or > 60 ans - Isolated intra-ocular lymphoma - Previous history of indolent lymphoma - Previous chemotherapy or radiotherapy for PCNSL - Isolated CNS relapse of systemic NHL - Previous history of cancer in the last 5 years, except basocellular carcinoma and non invasive cervix cancer - Renal insufficiency or creatinin clearance < 60 ml/min - Liver enzymes > 3N. - Platelets < 100 000/mm3 or neutrophils < 1500/mm3) - Previous history of organ transplantation or other cause of severe immunodeficiency - Pregnancy or active sexual women with no contraception - Unable to follow the protocol for any reason

Additional Information

Official title Prospective , Multicentric, Randomized Phase II Study, Evaluating the Role of Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue After Conventional Chemotherapy for Primary Central Nervous System in Young Patients (< 60 y)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Institut Curie.