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Mantel Cell Lymphoma Efficacy of Rituximab Maintenance

Primary Purpose

Mantle Cell Lymphoma

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Rituximab
Watch and wait
Sponsored by
French Innovative Leukemia Organisation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma focused on measuring Mantle cell lymphoma, R DHAP, ASCT, Rituximab Maintenance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • mantle cell lymphoma
  • Initial immunophenotyping with CD20 and CD5.
  • CD20+.
  • t (11;14) by karyote, FISH, molecular biology or immunohistochemistry (Bcl-1)
  • Patient no previous treated.
  • At least one tumor site accessible for assessment
  • Aged > 18 years < 65
  • ECOG < or = 2.
  • No other neoplasms apart from resected basal cell carcinoma or in situ carcinoma.
  • signed informed consent
  • FEVG 50%

Exclusion Criteria:

  • other type of lymphoma
  • ECOG > or = 3
  • relapse
  • serology VIH + Hepatite +
  • diabetis

Sites / Locations

  • Regional University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

observation : 3 years maintenance period with assesments and surveillance every 2 months

maintenance period infusions of Rituximab 375 mg/m2/2 months and assessement and surveillance

Outcomes

Primary Outcome Measures

event-free survival (EFS) post Rituximab maintenance therapy

Secondary Outcome Measures

duration of PFS of the entire group of patients.
duration of OS of the entire group of patients
complete, partial and overall response rate after induction with R-DHAP and after ASCT.

Full Information

First Posted
May 27, 2009
Last Updated
April 26, 2018
Sponsor
French Innovative Leukemia Organisation
Collaborators
Lymphoma Study Association
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1. Study Identification

Unique Protocol Identification Number
NCT00921414
Brief Title
Mantel Cell Lymphoma Efficacy of Rituximab Maintenance
Official Title
Manteau 2007 SJ "LYMA" "Randomized, Open-label, Phase III Study Efficacy of Rituximab Maintenance Therapy in Patients 18 to 65 Years , First-line Treatment for MCL
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Innovative Leukemia Organisation
Collaborators
Lymphoma Study Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Randomized, open-label, phase III study to evaluate the efficacy of rituximab maintenance therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment for mantle cell lymphoma and exhibiting a response after autologous transplantation.
Detailed Description
Demonstration of the superiority in terms of 4-year event-free survival (EFS) of Rituximab maintenance therapy compared to post-autograft surveillance in patients aged 18-65 years inclusive, treated with R-DHAP then autologous transplantation for MCL as first-line therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma
Keywords
Mantle cell lymphoma, R DHAP, ASCT, Rituximab Maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
299 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
observation : 3 years maintenance period with assesments and surveillance every 2 months
Arm Title
2
Arm Type
Experimental
Arm Description
maintenance period infusions of Rituximab 375 mg/m2/2 months and assessement and surveillance
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Mabthera®
Intervention Description
2 months after ASCT maintenance treatment with Rituximab 500mg/m² IV every 2 months during 3 years
Intervention Type
Other
Intervention Name(s)
Watch and wait
Other Intervention Name(s)
observation
Intervention Description
No treatment patient follow-up every 2 months during 3 years
Primary Outcome Measure Information:
Title
event-free survival (EFS) post Rituximab maintenance therapy
Time Frame
EFS post 4 years after maintenance
Secondary Outcome Measure Information:
Title
duration of PFS of the entire group of patients.
Time Frame
Safety/efficacy of maintenance treatment
Title
duration of OS of the entire group of patients
Time Frame
safety/efficacy of treatment
Title
complete, partial and overall response rate after induction with R-DHAP and after ASCT.
Time Frame
safety/efficacy of all the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: mantle cell lymphoma Initial immunophenotyping with CD20 and CD5. CD20+. t (11;14) by karyote, FISH, molecular biology or immunohistochemistry (Bcl-1) Patient no previous treated. At least one tumor site accessible for assessment Aged > 18 years < 65 ECOG < or = 2. No other neoplasms apart from resected basal cell carcinoma or in situ carcinoma. signed informed consent FEVG 50% Exclusion Criteria: other type of lymphoma ECOG > or = 3 relapse serology VIH + Hepatite + diabetis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven LE GOUILL, MD
Organizational Affiliation
French Innovative Leukemia Organisation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28953447
Citation
Le Gouill S, Thieblemont C, Oberic L, Moreau A, Bouabdallah K, Dartigeas C, Damaj G, Gastinne T, Ribrag V, Feugier P, Casasnovas O, Zerazhi H, Haioun C, Maisonneuve H, Houot R, Jardin F, Van Den Neste E, Tournilhac O, Le Du K, Morschhauser F, Cartron G, Fornecker LM, Canioni D, Callanan M, Bene MC, Salles G, Tilly H, Lamy T, Gressin R, Hermine O; LYSA Group. Rituximab after Autologous Stem-Cell Transplantation in Mantle-Cell Lymphoma. N Engl J Med. 2017 Sep 28;377(13):1250-1260. doi: 10.1056/NEJMoa1701769.
Results Reference
derived
Links:
URL
http://www.filo-leucemie.org
Description
FILO Website

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Mantel Cell Lymphoma Efficacy of Rituximab Maintenance

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