Patients with previously untreated Richter’s syndrome (RS), defined as the transformation of chronic lymphocytic leukemia (CLL) into high-grade lymphoma of diffuse large B-cell lymphoma (DLBCL) histology.
Conditions
Brief summary
Percentage of participants with a complete metabolic response (CMR) as assessed by the investigator using the Cheson IWG 2014 Lugano Classification (i.e. Deauville scale 1-3)50 after 6 cyles of R/G-CHOP 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).
Detailed description
• Toxicity according to the CTCAE v.5 and ASTCT Consensus grading for ICANS and CRS, • Overall response rate (ORR) according to Cheson IWG 2014 Lugano Classification (i.e. Deauville scale 1-3) after 4 and 6 cycles, • CR rate after 4 and 6 cycles according to Cheson IWG 2014 Lugano Classification (i.e. Deauville scale 1-3), • Progression free survival (PFS), • Time to next treatment (TTNT), • Response duration • Response regarding CLL according to the iwCLL 2018 criteria • Overall survival • Causes of death
Interventions
DRUGGazyvaro 1
DRUG000 mg concentrate for solution for infusion.
DRUGONCOVIN 1 mg
DRUGsolution injectable
DRUGCORTANCYL 20 mg
DRUGcomprimé sécable
DRUGsolution pour perfusion
DRUGGlofitamab
DRUGENDOXAN 1000 mg
DRUGpoudre pour solution injectable
Sponsors
French Innovative Leukemia Organization
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with a complete metabolic response (CMR) as assessed by the investigator using the Cheson IWG 2014 Lugano Classification (i.e. Deauville scale 1-3)50 after 6 cyles of R/G-CHOP 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Toxicity according to the CTCAE v.5 and ASTCT Consensus grading for ICANS and CRS, • Overall response rate (ORR) according to Cheson IWG 2014 Lugano Classification (i.e. Deauville scale 1-3) after 4 and 6 cycles, • CR rate after 4 and 6 cycles according to Cheson IWG 2014 Lugano Classification (i.e. Deauville scale 1-3), • Progression free survival (PFS), • Time to next treatment (TTNT), • Response duration • Response regarding CLL according to the iwCLL 2018 criteria • Overall survival • Causes of death | — |
Countries
France
Outcome results
None listed