Status:
ACTIVE_NOT_RECRUITING
Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue for Primary Central Nervous System Lymphoma in Young Patients
Lead Sponsor:
Institut Curie
Collaborating Sponsors:
Ministry of Health, France
Hoffmann-La Roche
Conditions:
Primary Central Nervous System Lymphoma
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
Purpose of the study : To evaluate the antitumoral effect of two therapeutic procedures and to evaluate their respective toxicity on the CNS.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 3 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00863460
Start Date
October 3 2008
End Date
May 1 2026
Last Update
February 5 2019
Active Locations (23)
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1
Cancérologie Hôpital Sud
Amiens, France, 80054
2
Chu D'Angers
Angers, France
3
CHR Argenteuil
Argenteuil, France, 95100
4
CHU de Besancon
Besançon, France