A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)

BeiGene

Status and phase: Not yet enrolling; Phase 3

Conditions: Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Drug: Rituximab; Drug: Sonrotoclax; Drug: Obinutuzumab; Drug: Venetoclax

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06943872

BGB-11417-303

CLL-RR1 (Other Identifier)

2024-517131-52-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.

Enrollment: 630 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of CLL/SLL that meets the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
• Received one or more prior therapies for CLL/SLL. For each line of therapy, participants must have received at least 2 cycles of the therapy
• Participants with prior BCL2i exposure are eligible if remission duration was ≥3 years with ≥2 years from last BCL2i intake
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
• Adequate organ function

Exclusion criteria

• Known active prolymphocytic leukemia or currently suspected Richter's transformation
• Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
• Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent
• Known central nervous system involvement by CLL/SLL
• Severe or debilitating pulmonary disease
• Clinically significant cardiovascular disease

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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630 participants in 4 patient groups

Arm A: Sonrotoclax plus Obinutuzumab

Experimental group

Description:

Sonrotoclax and obinutuzumab will be administered in combination.

Treatment:

Drug: Obinutuzumab

Drug: Sonrotoclax

Arm B: Sonrotoclax plus Rituximab

Experimental group

Description:

Sonrotoclax and rituximab will be administered in combination.

Treatment:

Drug: Sonrotoclax

Drug: Rituximab

Arm C: Sonrotoclax plus Obinutuzumab (MRD)

Experimental group

Description:

Sonrotoclax and obinutuzumab will be administered in combination with treatment guided by evaluation of minimal residual disease (MRD).

Treatment:

Drug: Obinutuzumab

Drug: Sonrotoclax

Arm D: Venetoclax plus Rituximab

Active Comparator group

Description:

Venetoclax and rituximab will be administered in combination.

Treatment:

Drug: Venetoclax

Drug: Rituximab