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)
Phase 2
18 Years
60 Years
18 Years
60 Years
Open (Enrolling)
Both
Primary Central Nervous System Lymphoma
Both
Primary Central Nervous System Lymphoma
Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
2-years progression-free survival in each arm
Outcome Time Frame:
2 years after inclusion
Safety Issue:
Yes
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
CRH 07/422/H
NCT ID:
NCT00863460
Start Date:
October 2008
Completion Date:
March 2015
Related Keywords:
- Primary Central Nervous System Lymphoma
- Lymphoma
Name | Location |
|---|
