Condition: Richter Syndrome · Sponsor: French Innovative Leukemia Organisation
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 Respon…
This description comes directly from the study's public registry record.
David Schwartz · +33247473798 · d.schwartz@filo-leucemie.org
Valérie Rouillé · +33247473798 · v.rouille@filo-leucemie.org
Always discuss trial participation with your own doctor first.
| Amiens-Picardie Chu | Amiens, France | Not Yet Recruiting |
| Angers Chu | Angers, France | Not Yet Recruiting |
| BAYONNE - CH de la Côte Basque - Hématologie | Bayonne, France | Not Yet Recruiting |
| Clermont-Ferrand - Chu Estaing | Clermont-Ferrand, France | Recruiting |
| Grenoble - CHUGA - Hématologie Clinique | Grenoble, France | Not Yet Recruiting |
| LILLE GHICL - Hôpital Saint Vincent de Paul | Lille, France | Not Yet Recruiting |
| LILLE CHU - Hôpital Claude Huriez | Lille, France | Not Yet Recruiting |
| LIMOGES - CHU Dupuytren 1 | Limoges, France | Not Yet Recruiting |
| LYON-Centre Léon Bérard | Lyon, France | Not Yet Recruiting |
| MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique | Montpellier, France | Not Yet Recruiting |
| APHP - Hôpital Saint-Louis - Hématologie adultes | Paris, France | Not Yet Recruiting |
| APHP - Hôpital Saint-Antoine - Hématologie et thérapie cellulaire | Paris, France | Not Yet Recruiting |
+ 11 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06186648