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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00863460
First Posted: March 18, 2009
Last Update Posted: January 24, 2017
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.
Collaborators:
Ministry of Health, France
Hoffmann-La Roche
Amgen
Pierre Fabre Laboratories
Information provided by (Responsible Party):
Institut Curie
  Purpose

Purpose of the study :

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


Condition Intervention Phase
Primary Central Nervous System Lymphoma Radiation: cranial radiotherapy Drug: intensive chemotherapy and hematopoietic stem cell rescue Drug: MTX based chemotherapy Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Institut Curie:

Primary Outcome Measures:
  • 2-years progression-free survival in each arm [ Time Frame: 2 years after inclusion ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 140
Study Start Date: October 2008
Estimated Study Completion Date: February 2025
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863460


Locations
France
Cancérologie Hôpital Sud
Amiens, France, 80054
Chu D'Angers
Angers, France
CHR Argenteuil
Argenteuil, France, 95100
CHU de Besancon
Besançon, France
Institut Bergonié
Bordeaux, France, 33076
CHU Hôtel Dieu
Clermont-Ferrand, France
CHU Michalon
Grenoble, France, 38043
Centre Hospitalier Lens
Lens, France
CHU de Limoges
Limoges, France, 87042
CHU de la Timone
Marseille, France, 13009
Hôtel Dieu Nantes
Nantes, France
Centre Antoine Lacassagne
Nice, France
CHU de Nimes
Nîmes, France
GH Pitié-Salpétrière
Paris, France, 75013
CHG Saint Jean
Perpignan, France, 66046
CHU Hôpital Bernard
Poitiers, France, 86021
Chu Reims
Reims, France
Hôpital Pontchaillou
Rennes, France, 35033
Centre René Huguenin
Saint Cloud, France, 92210
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, France, 54500
Sponsors and Collaborators
Institut Curie
Ministry of Health, France
Hoffmann-La Roche
Amgen
Pierre Fabre Laboratories
  More Information

Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT00863460     History of Changes
Other Study ID Numbers: CRH 07/422/H
EudraCT N° 2007-005378-30
First Submitted: March 16, 2009
First Posted: March 18, 2009
Last Update Posted: January 24, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Cytarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents


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