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

NCT06186648 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-10

No results posted yet for this study

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).

Conditions

  • Richter Syndrome

Interventions

DRUG

Glofitamab + 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

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • French Innovative Leukemia Organisation

    lead OTHER

Principal Investigators

  • Romain guièze, MD · Service d'hématologie clinique adulte et de thérapie cellulaire Etablissement : CHU Estaing

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-21
Primary Completion
2026-03-01
Completion
2027-03-01

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06186648 on ClinicalTrials.gov