NCT00921414

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
299

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2009

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
7.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

April 27, 2018

Status Verified

April 1, 2018

Enrollment Period

Same day

First QC Date

May 27, 2009

Last Update Submit

April 26, 2018

Conditions

Mantle Cell Lymphoma

Keywords

Mantle cell lymphomaR DHAPASCTRituximab Maintenance

Outcome Measures

Primary Outcomes (1)

  • event-free survival (EFS) post Rituximab maintenance therapy

    EFS post 4 years after maintenance

Secondary Outcomes (3)

  • duration of PFS of the entire group of patients.

    Safety/efficacy of maintenance treatment

  • duration of OS of the entire group of patients

    safety/efficacy of treatment

  • complete, partial and overall response rate after induction with R-DHAP and after ASCT.

    safety/efficacy of all the treatment

Study Arms (2)

1

ACTIVE COMPARATOR

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

Other: Watch and wait

2

EXPERIMENTAL

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

Drug: Rituximab

Interventions

RituximabDRUG

2 months after ASCT maintenance treatment with Rituximab 500mg/m² IV every 2 months during 3 years

Also known as: Mabthera®
2
Watch and waitOTHER

No treatment patient follow-up every 2 months during 3 years

Also known as: observation
1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional University Hospital

Nantes, 44093, France

Location

Related Publications (2)

  • Sarkozy C, Callanan M, Thieblemont C, Oberic L, Burroni B, Bouabdallah K, Damaj G, Tessoulin B, Ribrag V, Houot R, Morschhauser F, Griolet S, Joubert C, Cacheux V, Delwail V, Safar V, Gressin R, Cheminant M, Delfau-Larue MH, Hermine O, Macintyre E, Le Gouill S. Obinutuzumab vs rituximab for transplant-eligible patients with mantle cell lymphoma. Blood. 2024 Jul 18;144(3):262-271. doi: 10.1182/blood.2024023944.

    PMID: 38669626DERIVED

  • 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.

    PMID: 28953447DERIVED

Related Links

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

RituximabObservation

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsMethodsInvestigative Techniques

Study Officials

  • Steven LE GOUILL, MD

    French Innovative Leukemia Organisation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2009

First Posted

June 16, 2009

Study Start

September 1, 2008

Primary Completion

September 1, 2008

Study Completion

February 1, 2017

Last Updated

April 27, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)