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

Primary Purpose

Primary Central Nervous System Lymphoma

Status
Active
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
cranial radiotherapy
intensive chemotherapy and hematopoietic stem cell rescue
MTX based chemotherapy
Sponsored by
Institut Curie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Central Nervous System Lymphoma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancérologie Hôpital Sud
  • Chu D'Angers
  • CHR Argenteuil
  • CHU de Besancon
  • Institut Bergonié
  • CHU Hôtel Dieu
  • CHU Michalon
  • Centre Hospitalier Lens
  • CHU de Limoges
  • CHU de la Timone
  • Hôtel Dieu Nantes
  • Centre Antoine Lacassagne
  • CHU de Nimes
  • GH Pitié-Salpétrière
  • CHG Saint Jean
  • CHU Hôpital Bernard
  • Chu Reims
  • Hôpital Pontchaillou
  • Centre René Huguenin
  • Institut de Cancérologie
  • CH de Saint-Quentin
  • Hôpital Bretonneau
  • CHU Nancy - Hôpital Neurologique

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

MTX-based chemotherapy followed by WBRT

MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue

Outcomes

Primary Outcome Measures

2-years progression-free survival in each arm

Secondary Outcome Measures

Overall response rate at the end of the procedure
Overall survival
Event-free survival
Neurotoxicity

Full Information

First Posted
March 16, 2009
Last Updated
February 4, 2019
Sponsor
Institut Curie
Collaborators
Ministry of Health, France, Hoffmann-La Roche, Amgen, Pierre Fabre Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00863460
Brief Title
Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue for Primary Central Nervous System Lymphoma in Young Patients
Acronym
PRECIS
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 3, 2008 (Actual)
Primary Completion Date
May 17, 2016 (Actual)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie
Collaborators
Ministry of Health, France, Hoffmann-La Roche, Amgen, Pierre Fabre Laboratories

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Central Nervous System Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
MTX-based chemotherapy followed by WBRT
Arm Title
B
Arm Type
Experimental
Arm Description
MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue
Intervention Type
Radiation
Intervention Name(s)
cranial radiotherapy
Intervention Description
40 Gy
Intervention Type
Drug
Intervention Name(s)
intensive chemotherapy and hematopoietic stem cell rescue
Other Intervention Name(s)
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
Intervention Description
intensive chemotherapy and hematopoietic stem cell rescue
Intervention Type
Drug
Intervention Name(s)
MTX based chemotherapy
Other Intervention Name(s)
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
Intervention Description
R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58&59 and days79&80
Primary Outcome Measure Information:
Title
2-years progression-free survival in each arm
Time Frame
2 years after inclusion
Secondary Outcome Measure Information:
Title
Overall response rate at the end of the procedure
Time Frame
at the end of procedure at 1 and 2 years
Title
Overall survival
Time Frame
2 years after inclusion
Title
Event-free survival
Time Frame
2 years after inclusion
Title
Neurotoxicity
Time Frame
each years during ten years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carole Soussain, MD
Organizational Affiliation
Institut Curie - Hôpital René Huguenin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancérologie Hôpital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Chu D'Angers
City
Angers
Country
France
Facility Name
CHR Argenteuil
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Facility Name
CHU de Besancon
City
Besançon
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU Hôtel Dieu
City
Clermont-Ferrand
Country
France
Facility Name
CHU Michalon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Hospitalier Lens
City
Lens
Country
France
Facility Name
CHU de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Hôtel Dieu Nantes
City
Nantes
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
Country
France
Facility Name
CHU de Nimes
City
Nîmes
Country
France
Facility Name
GH Pitié-Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
CHG Saint Jean
City
Perpignan
ZIP/Postal Code
66046
Country
France
Facility Name
CHU Hôpital Bernard
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Chu Reims
City
Reims
Country
France
Facility Name
Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Centre René Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Institut de Cancérologie
City
Saint-Priest en Jarez
Country
France
Facility Name
CH de Saint-Quentin
City
Saint-Quentin
Country
France
Facility Name
Hôpital Bretonneau
City
Tours
Country
France
Facility Name
CHU Nancy - Hôpital Neurologique
City
Vandoeuvre les Nancy
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35834762
Citation
Houillier C, Dureau S, Taillandier L, Houot R, Chinot O, Molucon-Chabrot C, Schmitt A, Gressin R, Choquet S, Damaj G, Peyrade F, Abraham J, Delwail V, Gyan E, Sanhes L, Cornillon J, Garidi R, Delmer A, Al Jijakli A, Morel P, Waultier A, Paillassa J, Chauchet A, Gastinne T, Laadhari M, Plissonnier AS, Feuvret L, Cassoux N, Touitou V, Ricard D, Hoang-Xuan K, Soussain C; LOC Network for CNS Lymphoma. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients Age 60 Years and Younger: Long-Term Results of the Randomized Phase II PRECIS Study. J Clin Oncol. 2022 Nov 10;40(32):3692-3698. doi: 10.1200/JCO.22.00491. Epub 2022 Jul 14.
Results Reference
derived
PubMed Identifier
30785830
Citation
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.
Results Reference
derived

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

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