Spots Global Cancer Trial Database for Efficacy of Upfront and Maintenance Obinutuzumab in Mantle Cell Lymphoma Treated by DHAP and MRD Driven Maintenance
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Trial Identification
Brief Title: Efficacy of Upfront and Maintenance Obinutuzumab in Mantle Cell Lymphoma Treated by DHAP and MRD Driven Maintenance
Official Title: 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
Study ID: NCT02896582
Conditions
Study Description
Brief Summary: 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
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
CHRU Lille - Hôpital Claude Huriez, Lille, , France
CHU Limoges, Limoges, , France
CHU Montpellier, Montpellier, , France
CHU Nantes, Nantes, , France
Hôpital Saint Louis, Paris, , France
APHP - Hopital Necker, Paris, , France
CH Perpignan, Perpignan, , France
CHU de Haut Leveque, Pessac, , France
CHU Lyon Sud, Pierre Bénite, , France
CHU de Poitiers, Poitiers, , France
Centre Hospitalier Annecy-Genevois, Pringy, , France
CHU Robert Debré, Reims, , France
CHU Pontchaillou, Rennes, , France
Centre Henri Becquerel, Rouen, , France
Institut de Cancérologie de Loire, Saint priest en Jarez, , France
CHU de Strasbourg, Strasbourg, , France
I.U.C.T Oncopole, Toulouse, , France
CHRU Bretonneau, Tours, , France
CHU de Brabois, Vandoeuvre les Nancy, , France
Gustave Roussy Cancer Campus, Villejuif, , France
Contact Details
Name: Steven Le Gouill, Pr
Affiliation: Nantes University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Olivier Hermine, Pr
Affiliation: Hopital Necker - Paris
Role: PRINCIPAL_INVESTIGATOR
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