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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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : October 3, 2008
Actual Primary Completion Date : May 17, 2016
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 2-years progression-free survival in each arm [ Time Frame: 2 years after inclusion ]

Secondary Outcome Measures :
  1. Overall response rate at the end of the procedure [ Time Frame: at the end of procedure at 1 and 2 years ]
  2. Overall survival [ Time Frame: 2 years after inclusion ]
  3. Event-free survival [ Time Frame: 2 years after inclusion ]
  4. Neurotoxicity [ Time Frame: each years during ten years ]

Eligibility Criteria
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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
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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
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Sponsors and Collaborators
Institut Curie
Ministry of Health, France
Hoffmann-La Roche
Amgen
Pierre Fabre Laboratories
Investigators
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Principal Investigator: Carole Soussain, MD Institut Curie - Hôpital René Huguenin
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Houillier C, Taillandier L, Dureau S, Lamy T, Laadhari M, Chinot O, Molucon-Chabrot C, Soubeyran P, Gressin R, Choquet S, Damaj G, Thyss A, Abraham J, Delwail V, Gyan E, Sanhes L, Cornillon J, Garidi R, Delmer A, Tanguy ML, Al Jijakli A, Morel P, Bourquard P, Moles MP, Chauchet A, Gastinne T, Constans JM, Langer A, Martin A, Moisson P, Lacomblez L, Martin-Duverneuil N, Delgadillo D, Turbiez I, Feuvret L, Cassoux N, Touitou V, Ricard D, Hoang-Xuan K, Soussain C; Intergroupe GOELAMS-ANOCEF and the LOC Network for CNS Lymphoma. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients 60 Years of Age and Younger: Results of the Intergroup ANOCEF-GOELAMS Randomized Phase II PRECIS Study. J Clin Oncol. 2019 Apr 1;37(10):823-833. doi: 10.1200/JCO.18.00306. Epub 2019 Feb 20. Erratum In: J Clin Oncol. 2023 Aug 10;41(23):3961.

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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT00863460    
Other Study ID Numbers: CRH 07/422/H
EudraCT N° 2007-005378-30
First Posted: March 18, 2009    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Prednisone
Cyclophosphamide
Busulfan
Thiotepa
Carmustine
Methotrexate
Etoposide
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Abortifacient Agents, Nonsteroidal