RecruitingPhase 2NCT06186648

Evaluation of Treatment by Glofitamab in Combination With Rituximab or Obinutuzumab Plus CHOP in Patients With RIchter Syndrome

A Phase 2 Study Evaluating the Bispecific CD3xCD20 Antibody GLOfitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (CHOP) in Patients With RIchter Syndrome as Frontline therapY. A FILO Study


Sponsor

French Innovative Leukemia Organisation

Enrollment

40 participants

Start Date

Mar 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a national clinical trial, multicentric (28 centers), non-randomized phase 2 study. Population: Patients with previously untreated Richter's syndrome (RS), defined as the occurrence of an aggressive lymphoma (of diffuse large B-cell lymphoma histology) in a patient with chronic lymphocytic leukemia (CLL). Study treatment: The duration of each cycle is 21 days. Cycle 1: Participants will receive standard of care doses of R-CHOP in cycle 1 as follows: * Rituximab 375 mg/m² IV Day 1 * Cyclophosphamide 750 mg/m² IV Day 1 * Doxorubicin 50 mg/m² IV Day 1 * Vincristine 1.4 mg/m² \[capped at 2.0 mg\] IV Day 1 * Prednisone 60 mg/m2 per day PO Day 1-5 Cycle 2: In order to minimize cytokine release syndrome (CRS), participants will then receive G-CHOP as cycle 2 (with obinutuzumab) and glofitamab: * Obinutuzumab 1000 mg single dose IV Day 1 * Cyclophosphamide 750 mg/m² IV Day 1 * Doxorubicin 50 mg/m² IV Day 1 * Vincristine 1.4 mg/m² \[capped at 2.0 mg\] IV Day 1 * Prednisone 60 mg/m2 per day PO Day 1-5 * Glofitamab : administered intravenously (IV) as a step-up dose on Days 8 (2.5 mg) and 15 (10 mg) Cycle 3-6: Participants will receive standard of care doses of R-CHOP and Glofitamab as follows: * Rituximab 375 mg/m² IV Day 1 * Cyclophosphamide 750 mg/m² IV Day 1 * Doxorubicin 50 mg/m² IV Day 1 * Vincristine 1.4 mg/m² \[capped at 2.0 mg\] IV Day 1 * Prednisone 60 mg/m2 per day PO Day 1-5 * Glofitamab : 30 mg IV Day 8 Cycle 7 and 8 (only for patient in Complete Response or Partial response after Cycle 6): Cycle 7 and 8 consist of 2 infusions of glofitamab only at D8C7 and D8C8: ● Glofitamab : 30 mg IV Day 8 Primary endpoint Percentage of participants with a complete response as assessed by the investigator using the Cheson IWG 2014 Lugano Classification (i.e. Deauville scale 1-3) after 6 cycles of R/G-CHOP + glofitamab or at permanent treatment discontinuation. End of treatment is defined as after 6 cycles of R/G-CHOP + glofitamab. Permanent treatment discontinuation is defined as the discontinuation of all treatments (R/G-CHOP, glofitamab).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Glofitamab + Obinutuzumab for people with richter syndrome. The study is currently recruiting participants at 23 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGlofitamab + Obinutuzumab

Duration of each cycle is 21 days. Cycle 1: R-CHOP Cycle 2: G-CHOP + glofitamab (at this cycle onnly, Obinutuzumab will be injected instead of Rituximab in order to decreased the risk of cytokine released syndrome) Cycle 3-6: R-CHOP + glofitamab Cycle 7-8: glofitamab alone


Locations(23)

Amiens-Picardie Chu

Amiens, France

Angers Chu

Angers, France

BAYONNE - CH de la Côte Basque - Hématologie

Bayonne, France

Clermont-Ferrand - Chu Estaing

Clermont-Ferrand, France

Grenoble - CHUGA - Hématologie Clinique

Grenoble, France

LILLE GHICL - Hôpital Saint Vincent de Paul

Lille, France

LILLE CHU - Hôpital Claude Huriez

Lille, France

LIMOGES - CHU Dupuytren 1

Limoges, France

LYON-Centre Léon Bérard

Lyon, France

MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique

Montpellier, France

APHP - Hôpital Saint-Louis - Hématologie adultes

Paris, France

APHP - Hôpital Saint-Antoine - Hématologie et thérapie cellulaire

Paris, France

APHP - Hôpital Pitié Salpêtrière - Hématologie

Paris, France

Bordeaux Pessac

Pessac, France

LYON HCL - CH Lyon Sud

Pierre-Bénite, France

Reims Chu

Reims, France

RENNES - CHU Pontchaillou - Hématologie Clinique

Rennes, France

ROUEN - Centre Henri Becquerel - Service Hématologie Clinique

Rouen, France

Strasbourg - Icans

Strasbourg, France

Toulouse - IUCT Oncopole - Service d'Hématologie

Toulouse, France

TOURS - Hôpital Bretonneau

Tours, France

NANCY - CHU Brabois

Vandœuvre-lès-Nancy, France

VERSAILLES - Hôpital André Mignot

Versailles, France

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NCT06186648


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