Last updated 19 days ago

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)

630 patients around the world

Available in Brazil, Argentina, United States

BeiGene

17Research sites

630Patients around the world

This study is for people with

Leukemia

Chronic lymphocytic leukemia

From 18 Years

All Gender

: 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.

: 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.

Hospital Alemán

Av. Pueyrredón 1640, CABA, Buenos Aires

Centro de Internación e Investigación Clínica FUNDALEU

J. E. Uriburu 1450, CABA, Buenos Aires

Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires

Av. Crámer 1180, CABA, Buenos Aires

CETUS Hospital Dia Oncologia - Belo Horizonte

Av. do Contorno, 3800 - Santa Efigênia, Belo Horizonte - MG, 38082-049, Brazil

Hospital de Clínicas - Universidade Estadual de Campinas - UNICAMP

R. Vital Brasil, 251 - Cidade Universitária, Campinas - SP, 13083-888

Hospital Erasto Gaertner

R. Dr. Ovande do Amaral, 201 - Jardim das Américas, Curitiba - PR, 81520-060, Brazil

Complexo Hospitalar de Niterói - CHN

Tv. Lasalle, 12 - Centro, Niterói - RJ, 24020-096

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Rua Professor Annes Dias - Centro Histórico, Porto Alegre - RS, 90020-090, Brazil

Hospital Sao Lucas

Rio de Janeiro, 22061-080

Instituto D'or de Pesquisa e Ensino - Rio de Janeiro

Rio de Janeiro, 22281-100

StudyCELESTIAL-RRCLL

SponsorBeiGene

Study typeInterventional

Conditions

Chronic lymphocytic leukemia

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06943872