Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

Phase 2RecruitingNCT04895436

AbbVie75 enrolled

Overview

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess retreatment with venetoclax-obinutuzumab (VenG) in participants previously treated with fixed duration first-line (IL) therapy of venetoclax in combination with an anti-CD20 antibody +/- X (where X is any additional drug). Adverse events and change in disease activity will be assessed. Venetoclax is an approved drug for the treatment of CLL. Study doctors put the participants in 1 of 2 groups, called cohorts, based on when symptoms of CLL came back after previous treatment in first-line. Approximately 75 adult participants with CLL who have been treated with venetoclax in combination with an anti-CD20 antibody +/- X will be enrolled in the study in approximately 60 sites worldwide. Participants will receive intravenous (IV) obinutuzumab + oral venetoclax (VenG) in 28-day cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone, for a total treatment of 12 to 24 cycles, depending on the cohort. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Lymphocytic Leukemia (CLL)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Documented diagnosis of chronic lymphocytic leukemia (CLL) that requires treatment for CLL according to International Workshop for Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria. * Previously completed venetoclax + anti-CD20 antibody +/- X regimen as a fixed duration first-line (1L) therapy and achieved documented response, defined as complete remission, complete remission with incomplete marrow recovery, partial remission, or nodular partial remission. * More than 24 months (Cohort 1) or 12-24 months (Cohort 2) have elapsed between last dose of venetoclax and disease progression after completion of 1L treatment. Exclusion Criteria: \- Received intervening treatment for CLL after completing previous treatment with a venetoclax + anti-CD20 antibody +/- X regimen.

Locations (58)

Moores Cancer Center at UC San Diego /ID# 230157

La Jolla, California, United States

RECRUITING

Winship Cancer Institute of Emory University /ID# 230643

Atlanta, Georgia, United States

RECRUITING

Des Moines Oncology Research Association /ID# 232606

Des Moines, Iowa, United States

COMPLETED

Dana-Farber Cancer Institute /ID# 230061

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Overall response (OR) in Cohort 1 after end of combination treatment

OR is defined as the percentage of participants achieving a best response of partial remission (PR), nodular partial remission (nPR), complete remission with incomplete marrow recovery (CRi), or complete remission (CR). Disease assessments will be based on the 2018 International Workshop for Chronic Lymphocytic Leukemia (iwCLL) criteria for tumor response.

Time frame: 9 months

Secondary Outcomes

OR in Cohort 1 after end of combination treatment

OR rate is defined as the percentage of participants achieving a best response of CR or CRi

Time frame: 9 months

OR in Cohort 1 after end of treatment

OR is defined as the percentage of participants achieving a best response of PR, nPR, CRi, or CR. Disease assessments will be based on the 2018 iwCLL criteria for tumor response.

Time frame: 15 months

Time to Response (TTR) in Cohort 1

TTR is defined as the time from first dose until first response (PR or better).

Time frame: 15 months

Duration of Response (DOR) in Cohort 1

DOR is defined as the time from first response (PR or better) until progressive disease (PD) or death.

Time frame: 15 months

Time to Next Treatment (TTNT) for CLL in Cohort 1

TTNT is defined as the time from first dose until first dose of a non-protocol anti-CLL therapy.

Time frame: 15 months

Progression-free Survival (PFS) in Cohort 1

PFS is defined as the time from first dose until PD or death.

Time frame: 15 months

Overall Survival (OS) in Cohort 1

OS is defined as the time from first dose until death.

Time frame: 15 months

Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of combination treatment

Percentage of participants with uMRD rate, measured in peripheral blood.

Time frame: 9 months

Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of treatment

Percentage of participants with uMRD rate, measured in peripheral blood.

Time frame: 15 months

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

Overview

Conditions

Interventions

Eligibility

Locations (58)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts