Clincosm LogoSign in Get a demo

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

Sponsor
Institut Curie (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00863460
Collaborator
Ministry of Health, France (Other), Hoffmann-La Roche (Industry), Amgen (Industry), Pierre Fabre Laboratories (Industry)
140
Enrollment
23
Locations
2
Arms
210.9
Anticipated Duration (Months)
6.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Purpose of the study :

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: cranial radiotherapy
  • Drug: intensive chemotherapy and hematopoietic stem cell rescue
  • Drug: MTX based chemotherapy
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Oct 3, 2008
Actual Primary Completion Date :
May 17, 2016
Anticipated Study Completion Date :
May 1, 2026

Arms and Interventions

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: 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

    • 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 2-years progression-free survival in each arm [2 years after inclusion]

    Secondary Outcome Measures

    1. Overall response rate at the end of the procedure [at the end of procedure at 1 and 2 years]

    2. Overall survival [2 years after inclusion]

    3. Event-free survival [2 years after inclusion]

    4. Neurotoxicity [each years during ten years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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
    5 Institut Bergonié Bordeaux France 33076
    6 CHU Hôtel Dieu Clermont-Ferrand France
    7 CHU Michalon Grenoble France 38043
    8 Centre Hospitalier Lens Lens France
    9 CHU de Limoges Limoges France 87042
    10 CHU de la Timone Marseille France 13009
    11 Hôtel Dieu Nantes Nantes France
    12 Centre Antoine Lacassagne Nice France
    13 CHU de Nimes Nîmes France
    14 GH Pitié-Salpétrière Paris France 75013
    15 CHG Saint Jean Perpignan France 66046
    16 CHU Hôpital Bernard Poitiers France 86021
    17 Chu Reims Reims France
    18 Hôpital Pontchaillou Rennes France 35033
    19 Centre René Huguenin Saint Cloud France 92210
    20 Institut de Cancérologie Saint-Priest en Jarez France
    21 CH de Saint-Quentin Saint-Quentin France
    22 Hôpital Bretonneau Tours France
    23 CHU Nancy - Hôpital Neurologique Vandoeuvre les Nancy France 54500

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Carole Soussain, MD, Institut Curie - Hôpital René Huguenin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institut Curie
    ClinicalTrials.gov Identifier:
    NCT00863460
    Other Study ID Numbers:
    • CRH 07/422/H
    • EudraCT N° 2007-005378-30
    First Posted:
    Mar 18, 2009
    Last Update Posted:
    Feb 5, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Cytarabine
    Prednisone
    Cyclophosphamide
    Busulfan
    Thiotepa
    Carmustine
    Methotrexate
    Etoposide

    Study Results

    No Results Posted as of Feb 5, 2019