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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

Requirements for the patient

From 18 Years
All Gender

Medical requirements

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.

Sites

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
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