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)

BeOne Medicines

Status and phase

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.

Full description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

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)

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

Trial contacts and locations

156

Central trial contact

Study Director

Data sourced from clinicaltrials.gov

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