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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00863460
Recruitment Status : Active, not recruiting
First Posted : March 18, 2009
Last Update Posted : February 5, 2019
Sponsor:
Collaborators:
Ministry of Health, France
Hoffmann-La Roche
Amgen
Pierre Fabre Laboratories
Information provided by (Responsible Party):
Institut Curie

Tracking Information
First Submitted Date  ICMJE March 16, 2009
First Posted Date  ICMJE March 18, 2009
Last Update Posted Date February 5, 2019
Actual Study Start Date  ICMJE October 3, 2008
Actual Primary Completion Date May 17, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2009)
2-years progression-free survival in each arm [ Time Frame: 2 years after inclusion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2009)
  • Overall response rate at the end of the procedure [ Time Frame: at the end of procedure at 1 and 2 years ]
  • Overall survival [ Time Frame: 2 years after inclusion ]
  • Event-free survival [ Time Frame: 2 years after inclusion ]
  • Neurotoxicity [ Time Frame: each years during ten years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue for Primary Central Nervous System Lymphoma in Young Patients
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Central Nervous System Lymphoma
Intervention  ICMJE
  • Radiation: cranial radiotherapy
    40 Gy
  • 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
Study Arms  ICMJE
  • Active Comparator: A
    MTX-based chemotherapy followed by WBRT
    Interventions:
    • Radiation: cranial radiotherapy
    • Drug: MTX based chemotherapy
  • Experimental: B
    MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue
    Interventions:
    • Drug: intensive chemotherapy and hematopoietic stem cell rescue
    • Drug: MTX based chemotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 8, 2013)
140
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2009)
100
Estimated Study Completion Date  ICMJE May 2026
Actual Primary Completion Date May 17, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00863460
Other Study ID Numbers  ICMJE CRH 07/422/H
EudraCT N° 2007-005378-30
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Institut Curie
Original Responsible Party Carole Soussain MD, Centre René Huguenin
Current Study Sponsor  ICMJE Institut Curie
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Ministry of Health, France
  • Hoffmann-La Roche
  • Amgen
  • Pierre Fabre Laboratories
Investigators  ICMJE
Principal Investigator: Carole Soussain, MD Institut Curie - Hôpital René Huguenin
PRS Account Institut Curie
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP