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

Primary Central Nervous System Lymphoma Clinical Trial

— PRECIS  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00863460
• Other study ID #: CRH 07/422/H
• Secondary ID: EudraCT N° 2007-
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 3, 2008
• Est. completion date: May 2026

Study information

• Verified date: February 2019
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose of the study :

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: May 2026
• Est. primary completion date: May 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Primary Central Nervous System Lymphoma

Intervention

Radiation:
• cranial radiotherapy
40 Gy

Drug:
• intensive chemotherapy and hematopoietic stem cell rescue
intensive chemotherapy and hematopoietic stem cell rescue
• MTX based chemotherapy
R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58&59 and days79&80

Locations

Country	Name	City	State
France	Cancérologie Hôpital Sud	Amiens
France	Chu D'Angers	Angers
France	CHR Argenteuil	Argenteuil
France	CHU de Besancon	Besançon
France	Institut Bergonié	Bordeaux
France	CHU Hôtel Dieu	Clermont-Ferrand
France	CHU Michalon	Grenoble
France	Centre Hospitalier Lens	Lens
France	CHU de Limoges	Limoges
France	CHU de la Timone	Marseille
France	Hôtel Dieu Nantes	Nantes
France	Centre Antoine Lacassagne	Nice
France	CHU de Nimes	Nîmes
France	GH Pitié-Salpétrière	Paris
France	CHG Saint Jean	Perpignan
France	CHU Hôpital Bernard	Poitiers
France	Chu Reims	Reims
France	Hôpital Pontchaillou	Rennes
France	Centre René Huguenin	Saint Cloud
France	Institut de Cancérologie	Saint-Priest en Jarez
France	CH de Saint-Quentin	Saint-Quentin
France	Hôpital Bretonneau	Tours
France	CHU Nancy - Hôpital Neurologique	Vandoeuvre les Nancy

Sponsors (5)

Lead Sponsor	Collaborator
Institut Curie	Amgen, Hoffmann-La Roche, Ministry of Health, France, Pierre Fabre Laboratories

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-years progression-free survival in each arm		2 years after inclusion
Secondary	Overall response rate at the end of the procedure		at the end of procedure at 1 and 2 years
Secondary	Overall survival		2 years after inclusion
Secondary	Event-free survival		2 years after inclusion
Secondary	Neurotoxicity		each years during ten years