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

Sponsor
French Innovative Leukemia Organisation
Study ID
NCT06186648
Phase
PHASE2
Status
Recruiting
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Conditions

  • Richter Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Glofitamab + Obinutuzumab — DRUG
    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

Study Details

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).

Key Dates

Start date
Mar 21, 2024
Status verified
Dec 2025
Primary completion
Mar 1, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Glofitamab + Obinutuzumab
    cf Intervention

Primary Outcome Measure

Objective response regarding Richter Syndrome to R/G-CHOP + glofitamab combination. [ Time Frame: 6 cycles (each cycle is 21 days) ]

Central Contacts

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