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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Centre Rene Huguenin
Sponsor:
Collaborators:
Ministry of Health, France
Hoffmann-La Roche
Amgen
Pierre Fabre Laboratories
Information provided by (Responsible Party):
Centre Rene Huguenin
ClinicalTrials.gov Identifier:
NCT00863460
First received: March 16, 2009
Last updated: July 8, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Centre Rene Huguenin:

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

Secondary Outcome Measures:
  • Overall response rate at the end of the procedure [ Time Frame: at the end of procedure at 1 and 2 years ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 2 years after inclusion ] [ Designated as safety issue: Yes ]
  • Event-free survival [ Time Frame: 2 years after inclusion ] [ Designated as safety issue: No ]
  • Neurotoxicity [ Time Frame: each years during ten years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: October 2008
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: October 2014 (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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863460

Contacts
Contact: Carole Soussain, MD 33 1 47 11 15 15 soussain@curie.net
Contact: Emmanuelle J Fourme, MD 33 1 47 11 16 59 e.fourme@curie.net

Locations
France
Cancérologie Hôpital Sud Recruiting
Amiens, France, 80054
Contact: Gandhi Damaj, MD       damaj.gandhi@chu-amiens.fr   
Principal Investigator: Damaj Gandhi, MD         
CHR Argenteuil Recruiting
Argenteuil, France, 95100
Contact: Al Jijakli Ahmad Kanj, MD       ahmad.aljijakli@ch-argenteuil.fr   
Principal Investigator: Al Jijakli Ahmad Kanj, MD         
Centre hospitalier de la Cote Basque Recruiting
Bayonne, France, 64109
Contact: Bauduer Frédéric, MD         
Contact       fbauduer001@chicb.com   
Principal Investigator: Bauduer Frédéric, MD         
Hôpital Saint André Recruiting
Bordeaux, France, 33075
Contact: Demeaux Hélène, MD       helene.demeaux@chu-bordeaux.fr   
Principal Investigator: Demeaux Hélène, MD         
Institut Bergonié Recruiting
Bordeaux, France, 33076
Contact: Soubeyran Pierre, PH       p_soubeyran@bergonie.org   
Principal Investigator: Soubeyran Pierre, PH         
CHG Recruiting
Béziers, France, 34500
Contact: Saad Alain, MD       alain.saad@ch-beziers.fr   
Principal Investigator: Saad Alain, MD         
CHU de Caen Recruiting
Caen, France, 14033
Contact: Reman Oumedaly, MD         
Principal Investigator: Reman Oumedaly, MD         
CHU Michalon Recruiting
Grenoble, France, 38043
Contact: Gressin Rémi, MD       rgressin@chu-grenoble.fr   
Principal Investigator: Gressin Rémi, MD         
CHU de Limoges Recruiting
Limoges, France, 87042
Contact: Jaccard Arnaud, MD         
CHU de la Timone Recruiting
Marseille, France, 13009
Contact: Bouabdallah Réda, MD       bouabdr@marseille.fnclcc.fr   
Principal Investigator: Bouabdallah Réda, MD         
CHR Orléans Hôpital de la Source Recruiting
Orléans, France, 45067
Contact: Paszek-Alexis Magda, MD       magda.alexis@chr-orléans.fr   
Principal Investigator: Paszek-Alexis Magda, MD         
GH Pitié-Salpétrière Recruiting
Paris, France, 75013
Contact: Hoang-Xuan Khê, PH       khe.hoang-xuan@psl.aphp.fr   
Principal Investigator: Hoang-Xuan Khê, PH         
Hôpital Cochin Recruiting
Paris, France, 75679
Contact: Dreyfus François, PH         
Principal Investigator: Dreyfus François, PH         
CHG Saint Jean Recruiting
Perpignan, France, 66046
Contact: Sanhes Laurence, MD       laurence.sanhes@ch-perpignan.fr   
Principal Investigator: Sanhes Laurence, MD         
CHU Hôpital Bernard Recruiting
Poitiers, France, 86021
Contact: Delwail Vincent, MD       V.delwail@chu-poitiers.fr   
Principal Investigator: Delvail Vincent, MD         
Hôpital Pontchaillou Recruiting
Rennes, France, 35033
Contact: Lamy Thierry, PH       thierry.lamy@univ-rennes1.fr   
Principal Investigator: Lamy Thierry, PH         
Centre René Huguenin Recruiting
Saint Cloud, France, 92210
Contact: Carole Soussain, MD    +33 1 47111515    soussain@curie.net   
Principal Investigator: Carole Soussain, MD         
CHU Nancy - Hôpital Neurologique Recruiting
Vandoeuvre les Nancy, France, 54500
Contact: Taillandier Luc, MD       l.taillandier@chu-nancy.fr   
Principal Investigator: Taillandier Luc, MD         
Centre Hospitalier Bretagne Atlantique Recruiting
Vannes, France, 56017
Contact: Jardel Henry, MD       henry.jardel@ch-bretagne-atlantique.fr   
Principal Investigator: Jardel Henry, MD         
Sponsors and Collaborators
Centre Rene Huguenin
Ministry of Health, France
Hoffmann-La Roche
Amgen
Pierre Fabre Laboratories
  More Information

No publications provided

Responsible Party: Centre Rene Huguenin
ClinicalTrials.gov Identifier: NCT00863460     History of Changes
Other Study ID Numbers: CRH 07/422/H, EudraCT N° 2007-005378-30
Study First Received: March 16, 2009
Last Updated: July 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 18, 2014