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

• ClinicalTrials.gov Identifier: NCT00863460
• Recruitment Status: Active, not recruiting
• First Posted: March 18, 2009
• Last Update Posted: February 5, 2019
• Sponsor: Institut Curie
• Collaborators: Ministry of Health, France; Hoffmann-La Roche; Amgen; Pierre Fabre Laboratories
• Information provided by (Responsible Party): Institut Curie

Tracking Information

• First Submitted Date: March 16, 2009
• First Posted Date: March 18, 2009
• Last Update Posted Date: February 5, 2019
• Actual Study Start Date: October 3, 2008
• Actual Primary Completion Date: May 17, 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 17, 2009): 2-years progression-free survival in each arm [ Time Frame: 2 years after inclusion ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue for Primary Central Nervous System Lymphoma in Young Patients
• 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)

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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Primary Central Nervous System Lymphoma

Intervention

• 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

• 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 *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 8, 2013): 140
• Original Estimated Enrollment (submitted: March 17, 2009): 100
• Estimated Study Completion Date: May 2026
• Actual Primary Completion Date: May 17, 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00863460
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Current Responsible Party: Institut Curie
• Original Responsible Party: Carole Soussain MD, Centre René Huguenin
• Current Study Sponsor: Institut Curie
• Original Study Sponsor: Same as current

Collaborators

• Ministry of Health, France
• Hoffmann-La Roche
• Amgen
• Pierre Fabre Laboratories

Investigators

• Principal Investigator: Carole Soussain, MD; Institut Curie - Hôpital René Huguenin

• PRS Account: Institut Curie
• Verification Date: February 2019