A Phase 3 Randomized, Open-Label, Multicenter Study of So... | EligiMed

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

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06943872RENIS: IS005029Tipo: INTERVENTIONALInicio: 11 de jun de 2025Fin estimado: 1 de dic de 2031

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Resumen

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.

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Sonrotoclax

Administered orally

drug

Obinutuzumab

Administered intravenously

drug

Rituximab

Administered intravenously

drug

Venetoclax

Administered Orally

Ubicaciones

FUNDALEU

Caba, Argentina

RECRUITING

Patrocinadores

PrincipalBeOne Medicines

ColaboradorGerman CLL Study Group

Contactos

Study Director

CONTACT

clinicaltrials@beonemed.com 1-877-828-5568

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.