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)

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sonrotoclax — DRUG
  Administered orally
• Obinutuzumab — DRUG
  Administered intravenously
• Rituximab — DRUG
  Administered intravenously
• Venetoclax — DRUG
  Administered Orally

Study Details

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.

Key Dates

Start date

Jun 11, 2025

Status verified

Mar 2026

Primary completion

Sep 30, 2029

Completion

Dec 31, 2031

Study Design

Enrollment

630 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Sonrotoclax plus Obinutuzumab
  Sonrotoclax and obinutuzumab will be administered in combination.
• Experimental: Arm B: Sonrotoclax plus Rituximab
  Sonrotoclax and rituximab will be administered in combination.
• Experimental: Arm C: Sonrotoclax plus Obinutuzumab (MRD)
  Sonrotoclax and obinutuzumab will be administered in combination with treatment guided by evaluation of minimal residual disease (MRD).
• Active Comparator: Arm D: Venetoclax plus Rituximab
  Venetoclax and rituximab will be administered in combination.

Primary Outcome Measure

Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) for Arm A versus Arm D [ Time Frame: Up to approximately 51 months ]

Central Contacts

• Study Director
  1-877-828-5568
  [email protected]

Locations (34)

Find similar trials in Laguna Hills, CA

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