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

Institut Curie

Status and phase: Active, not recruiting; Phase 2

Conditions: Primary Central Nervous System Lymphoma

Treatments: Radiation: cranial radiotherapy; Drug: intensive chemotherapy and hematopoietic stem cell rescue; Drug: MTX based chemotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00863460

EudraCT N° 2007-005378-30

CRH 07/422/H

Details and patient eligibility

About

Purpose of the study :

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

Enrollment: 140 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

A

Active Comparator group

Description:

MTX-based chemotherapy followed by WBRT

Treatment:

Radiation: cranial radiotherapy

Drug: MTX based chemotherapy

B

Experimental group

Description:

MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue

Treatment:

Drug: MTX based chemotherapy

Drug: intensive chemotherapy and hematopoietic stem cell rescue