Early Clonal Dynamics During Venetoclax Treatment for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Summary

Participation Requirements

Description

This study aims to study the clonal dynamics and kinetics of response during the ramp-up phase of venetoclax in chronic lymphocytic leukemia (CLL). Key Eligibility Criteria: Diagnosis of CLL/SLL (treatment naive or relapsed/refractory) Must have designated hematologist/oncologist who has agreed to a...

This study aims to study the clonal dynamics and kinetics of response during the ramp-up phase of venetoclax in chronic lymphocytic leukemia (CLL). Key Eligibility Criteria: Diagnosis of CLL/SLL (treatment naive or relapsed/refractory) Must have designated hematologist/oncologist who has agreed to assume care and continue venetoclax after the ramp-up phase is complete Age greater than or equal to 18 years ECOG 0-2 Design: Patients with CLL/SLL will enroll on the study. Subjects will be treated at the NIH Clinical Center for the duration of the ramp-up phase of venetoclax. After the ramp-up phase is complete, subjects will be transitioned to the care of their local hematologist/oncologist and receive venetoclax monotherapy or in combination with other agent(s) at the discretion of the treating oncologist. Subjects will have the option to follow-up at the NIH every 6 months (from initiation of venetoclax) and at (suspected) progression. Study Objectives: Primary Objective: -Determine the proportion of subjects with clonal shift during the ramp-up phase of venetoclax Secondary Objective: -Determine response kinetics of venetoclax therapy in the peripheral blood, lymph nodes and bone marrow Exploratory Objectives: Assess relationship between clonal shifts and minimal residual disease (MRD) status, progression free survival (PFS) and overall survival (OS) Assess immunologic changes in the peripheral blood and bone marrow during venetoclax treatment Assess circulating-tumor DNA in response to treatment during venetoclax treatment

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