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Phase II Study to Evaluate the Efficacy of Upfront Obinutuzumab in Mantle Cell Lymphoma Patients Treated by DHAP Followed by Autologous Transplantation Plus Obinutuzumab Maintenance Then MRD Driven Maintenance
This study is a multicentric, single arm phase II trial to evaluate the efficacy of upfront obinutuzumab in mantle cell lymphoma patients treated by Cisplatinum-Cytarabine-Dexamethasone (DHAP) followed by autologous transplantation plus obinutuzumab maintenance then Molecular Residual Disease (MRD) driven maintenance
Patients will be recruited over 2 years. They must have a histologically proven diagnosis of mantle cell lymphoma, be aged from 18 to 65 years at the time of registration. Patients must be eligible for autologous transplant and not previously treated for their lymphoma at inclusion. Patients will receive 4 cycles of Obinutuzumab (GA101) and Cisplatinum-Cytarabine-Dexamethasone (GA-DHAP) every 21 days followed by Autologous Stem Cell Transplant (ASCT) using a GA101-Carmustine- Etoposide- Cytarabine- Melphalan (GA-BEAM) conditioning regimen plus a Obinutuzumab maintenance for 3 years then a Obinutuzumab maintenance on demand according to MRD status. Stem cells will be collected after cycle 3 and/or 4 of GA-DHAP.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
CHU d'Amiens
Amiens, France
CHU d'Angers
Angers, France
CH d'Avignon
Avignon, France
CHU de Caen
Caen, France
CHU de Clermont Ferrand
Clermont-Ferrand, France
Hopital Henri Mondor
Créteil, France
CHU de Dijon - Hôpital le Bocage
Dijon, France
CHU de Grenoble
Grenoble, France
CHD Vendée
La Roche-sur-Yon, France
Clinique Victor Hugo
Le Mans, France
Start Date
November 29, 2016
Primary Completion Date
March 1, 2019
Completion Date
December 2, 2024
Last Updated
January 14, 2026
86
ACTUAL participants
Obinutuzumab
DRUG
Dexamethasone
DRUG
Aracytine
DRUG
Cisplatinum
DRUG
Etoposide
DRUG
Melphalan
DRUG
Carmustine
DRUG
Lead Sponsor
The Lymphoma Academic Research Organisation
NCT05529069
NCT06263491
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05006716