S1925: Phase III Study of Newly Diagnosed Asymptomatic High-Risk Patents with CLL/SLL - Clinical Trial

¿Cuál es el Propósito de este estudio?

We are doing this study to compare the early treatment (before you have cancer symptoms) of Venetoclax and Obitnutuzumab (V-O) to the usual treatment of V-O after you have cancer symptoms. This study will help doctors figure out if early treatment is better, the same, or worse than the usual approach of waiting until the patient has cancer symptoms before starting treatment.

¿Cuál es la Condición que se está estudiando?

Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)

¿Quién puede participar en el Estudio?

Adults ages 18+ who:

  • Are asymptomatic, high-risk patients with newly diagnosed CLL or SLL
  • Have not received any current or previous treatment for CLL or SLL, including investigational drugs
  • Do not have a bleeding disorder

Para obtener más información sobre quién puede participar en este estudio, comuníquese con el equipo del estudio al 919-684-8964.

Grupo etario
Adultos

¿Qué Implica?

If you choose to join this study, you will get an assignment to 1 of 2 treatment groups:

  • Group1 (Delayed Treatment/Usual Approach) will get the usual drugs to treat this type of cancer. You will start the treatment at the usual time when you have the cancer symptoms. The drugs are given in cycles that last 28 days.
  • Group 2 (Early Treatment) will get the same drugs as patients in Group 1. You will start the treatment right away, which will be before you have any cancer symptoms.

Los participantes de ambos grupos:

  • Fill out questionnaires
  • Realizar extracciones de sangre
  • Tomar muestras de médula ósea
  • Have imaging scans (CT)

Detalles del Estudio

Título Completo
SWOG S1925: Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab Versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study
Investigador Principal
Danielle M. Brander, MD
Especialista en oncología hematológica
Número de Protocolo
IRB: PRO00110390
NCT: NCT04269902
Fase
Phase III
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
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