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

February 4, 2019 updated by: Institut Curie

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)

Purpose of the study :

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • Cancérologie Hôpital Sud
      • Angers, France
        • CHU d'Angers
      • Argenteuil, France, 95100
        • CHR Argenteuil
      • Besançon, France
        • CHU de Besançon
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Clermont-Ferrand, France
        • Chu Hotel Dieu
      • Grenoble, France, 38043
        • CHU Michalon
      • Lens, France
        • Centre Hospitalier Lens
      • Limoges, France, 87042
        • CHU de Limoges
      • Marseille, France, 13009
        • CHU de la Timone
      • Nantes, France
        • Hotel Dieu Nantes
      • Nice, France
        • Centre Antoine Lacassagne
      • Nîmes, France
        • CHU de Nîmes
      • Paris, France, 75013
        • GH Pitié-Salpêtrière
      • Perpignan, France, 66046
        • CHG Saint Jean
      • Poitiers, France, 86021
        • CHU Hôpital Bernard
      • Reims, France
        • Chu Reims
      • Rennes, France, 35033
        • Hopital Pontchaillou
      • Saint Cloud, France, 92210
        • Centre René Huguenin
      • Saint-Priest en Jarez, France
        • Institut de cancerologie
      • Saint-Quentin, France
        • CH de Saint-Quentin
      • Tours, France
        • Hôpital Bretonneau
      • Vandoeuvre les Nancy, France, 54500
        • CHU Nancy - Hôpital Neurologique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
MTX-based chemotherapy followed by WBRT
Radiation: cranial radiotherapy
40 Gy
Drug: MTX based chemotherapy
R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58&59 and days79&80
Other Names:
  • R-RMVP :
  • Rituximab IV if LNH type B (375 mg/m²) day1
  • Methotrexate IV (3g/m² during 30 minutes) day1 and day15
  • Etoposide IV (100 mg/m²) day2
  • Carmustine IV (100 mg/m²) day3
  • Prednisone PO (60 mg/m²/day)day1 to day5
  • R-Aracytine :
  • Aracytine IV (3g/m²) day1 & day2
Experimental: B
MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue
Drug: MTX based chemotherapy
R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58&59 and days79&80
Other Names:
  • R-RMVP :
  • Rituximab IV if LNH type B (375 mg/m²) day1
  • Methotrexate IV (3g/m² during 30 minutes) day1 and day15
  • Etoposide IV (100 mg/m²) day2
  • Carmustine IV (100 mg/m²) day3
  • Prednisone PO (60 mg/m²/day)day1 to day5
  • R-Aracytine :
  • Aracytine IV (3g/m²) day1 & day2
Drug: intensive chemotherapy and hematopoietic stem cell rescue
intensive chemotherapy and hematopoietic stem cell rescue
Other Names:
  • Thiotepa IV (250 mg/m²/day) day-9 day-8 day-7
  • Busulfan IV (0.8 mg/kg X 10) day-6 to day-4
  • Cyclophosphamide IV (60 mg/kg/day) day-3 & day-2
  • Reinjection of hematopoietic stem cells day0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
2-years progression-free survival in each arm
Time Frame: 2 years after inclusion
2 years after inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2 years after inclusion
2 years after inclusion
Overall response rate at the end of the procedure
Time Frame: at the end of procedure at 1 and 2 years
at the end of procedure at 1 and 2 years
Event-free survival
Time Frame: 2 years after inclusion
2 years after inclusion
Neurotoxicity
Time Frame: each years during ten years
each years during ten years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Collaborators

Hoffmann-La Roche
Ministry of Health, France
Amgen
Pierre Fabre Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2008

Primary Completion (Actual)

May 17, 2016

Study Completion (Anticipated)

May 1, 2026

Study Registration Dates

First Submitted

March 16, 2009

First Submitted That Met QC Criteria

March 17, 2009

First Posted (Estimate)

March 18, 2009

Study Record Updates

Last Update Posted (Actual)

February 5, 2019

Last Update Submitted That Met QC Criteria

February 4, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRH 07/422/H
  • EudraCT N° 2007-005378-30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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