RightFit
RecruitingPhase 3

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)

A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares sonrotoclax plus obinutuzumab or rituximab with venetoclax plus rituximab to see how long they keep cancer from getting worse. It is for adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) that has come back or has not responded to treatment. The study also checks the safety of these treatments.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have CLL/SLL confirmed using the study’s required diagnosis rules.
  • Have had at least one past treatment for CLL/SLL, with at least 2 treatment cycles for each course of treatment.
  • If you took a BCL2 inhibitor, a type of cancer drug, your cancer must have stayed improved for at least 3 years, and your last dose must have been at least 2 years ago.
  • Have an ECOG activity score of 0, 1, or 2: you can care for yourself and are out of bed for more than half of your waking hours.
  • Have organs that work well enough for the study.

Who can't join

  • Have active prolymphocytic leukemia, another blood cancer, or signs that CLL/SLL may have changed into a faster-growing cancer called Richter’s transformation.
  • Had a stem cell transplant using your own cells or CAR T-cell therapy, which uses changed immune cells to fight cancer, within 3 months before the first study dose.
  • Had a donor stem cell transplant and have active graft-versus-host disease (GVHD), where donor cells attack your body; need immune-suppressing drugs for GVHD; or took drugs called calcineurin inhibitors within 4 weeks before giving consent.
  • Have CLL/SLL in the brain or spinal cord.
  • Have severe lung disease or lung disease that greatly limits daily life.
  • Have significant heart or blood vessel disease.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (39)

CA

CO

CT

FL

IA

IL

KY

LA

MA

MD

MI

MN

NC

NE

NJ

NM

NY

OH

OR

PA

TN

TX

WA