About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma according to the revised iwCLL criteria with biopsy proven transformation to CD20 positive diffuse large B-cell lymphoma, consistent with RS according to the 2016 WHO classification
A fresh or archival tissue biopsy is mandatory
Previous therapy for CLL is allowed (but no prior therapy for RS)
Age greater than or equal to 18 years and less or equal to 80 years
Disqualifiers
Patients with the Hodgkin variant of RS
Patients with previously treated for RS
Current or past history or presence of clinically relevant disorder affecting the central nervous system (CNS)
Ineligible to CHOP full dose for any reason
Trial design
Single group
Treatments tested in this trial
Glofitamab + Obinutuzumab
DrugDuration 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
Treatment groups
Trial outcomes
Primary outcomes
Objective response regarding Richter Syndrome to R/G-CHOP + glofitamab combination.
Percentage of patients with a complete response (CR) assessed using the Cheson IWG 2014 Lugano Classification (i.e. Deauville scale 1-3)
Secondary outcomes
Safety and toxicity of the R/G-CHOP + glofitamab combination
Advers events evaluation according to the Common Terminology Criteria for Adverse Events (CTCAE) v.5 and American Society for Transplantation and Cellular Therapy (ASTCT) Consensus grading for International Conference on Harmonization (ICANS) and Cytokine Release Syndrom (CRS)
Sponsors and contacts
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French Innovative Leukemia Organisation
Lead sponsor
Hoffmann-La Roche
Collaborator