Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue for Primary Central Nervous System Lymphoma in Young Patients

Phase 2

Active, not recruiting

• Conditions: Primary Central Nervous System Lymphoma
• Interventions: Radiation: cranial radiotherapy; Drug: intensive chemotherapy and hematopoietic stem cell rescue; Drug: MTX based chemotherapy

• Registration Number: NCT00863460
• Lead Sponsor: Institut Curie

Brief Summary

Purpose of the study :

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-03
• Study First Submitted: 2009-03-16
• Study First Submitted QC: 2009-03-17
• Study First Posted: 2009-03-18
• Primary Completion: 2016-05-17
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-04
• Last Update Posted: 2019-02-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	cranial radiotherapy	MTX-based chemotherapy followed by WBRT
A	MTX based chemotherapy	MTX-based chemotherapy followed by WBRT
B	intensive chemotherapy and hematopoietic stem cell rescue	MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue
B	MTX based chemotherapy	MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue

Primary Outcome Measures

Name	Time	Method
2-years progression-free survival in each arm	2 years after inclusion

Secondary Outcome Measures

Name	Time	Method
Overall response rate at the end of the procedure	at the end of procedure at 1 and 2 years
Overall survival	2 years after inclusion
Event-free survival	2 years after inclusion
Neurotoxicity	each years during ten years

Trial Locations

Locations (23)

GH Pitié-Salpétrière; 🇫🇷 Paris, France

Hôpital Bretonneau; 🇫🇷 Tours, France

CHR Argenteuil; 🇫🇷 Argenteuil, France

CHU de Besancon; 🇫🇷 Besançon, France

Hôtel Dieu Nantes; 🇫🇷 Nantes, France

CHU Hôpital Bernard; 🇫🇷 Poitiers, France

Hôpital Pontchaillou; 🇫🇷 Rennes, France

CHU de la Timone; 🇫🇷 Marseille, France

Cancérologie Hôpital Sud; 🇫🇷 Amiens, France

Chu Reims; 🇫🇷 Reims, France

Institut de Cancérologie; 🇫🇷 Saint-Priest en Jarez, France

CHU de Limoges; 🇫🇷 Limoges, France

Chu D'Angers; 🇫🇷 Angers, France

Institut Bergonié; 🇫🇷 Bordeaux, France

CHU Hôtel Dieu; 🇫🇷 Clermont-Ferrand, France

Centre Hospitalier Lens; 🇫🇷 Lens, France

CHU Michalon; 🇫🇷 Grenoble, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

CHG Saint Jean; 🇫🇷 Perpignan, France

CHU de Nimes; 🇫🇷 Nîmes, France

Centre René Huguenin; 🇫🇷 Saint Cloud, France

CH de Saint-Quentin; 🇫🇷 Saint-Quentin, France

CHU Nancy - Hôpital Neurologique; 🇫🇷 Vandoeuvre les Nancy, France