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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)

NCT04895436

Description:

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess how well venetoclax + obinutuzumab (VenG) works and how safe they are in adult participants with CLL who were previously treated with VenG. 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 treatment arms, based on when symptoms of CLL came back after previous treatment with VenG. Approximately 75 adult participants with CLL who have been treated with VenG 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.

Related Conditions:
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04895436

Trial Eligibility

Document

Title

  • Brief Title: 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)
  • Official Title: A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients With Recurring Chronic Lymphocytic Leukemia

Clinical Trial IDs

  • ORG STUDY ID: M20-356
  • SECONDARY ID: 2021-001037-39
  • NCT ID: NCT04895436

Conditions

  • Chronic Lymphocytic Leukemia (CLL)

Interventions

DrugSynonymsArms
VenetoclaxVenclexta, ABT-199, GDC-0199Cohort 1 - venetoclax + obinutuzumab
ObinutuzumabGA101Cohort 1 - venetoclax + obinutuzumab

Purpose

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess how well venetoclax + obinutuzumab (VenG) works and how safe they are in adult participants with CLL who were previously treated with VenG. 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 treatment arms, based on when symptoms of CLL came back after previous treatment with VenG. Approximately 75 adult participants with CLL who have been treated with VenG 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.

Trial Arms

NameTypeDescriptionInterventions
Cohort 1 - venetoclax + obinutuzumabExperimentalParticipants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles.
  • Venetoclax
  • Obinutuzumab
Cohort 2 - venetoclax + obinutuzumabExperimentalParticipants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles.
  • Venetoclax
  • Obinutuzumab

Eligibility Criteria

        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 + obinutuzumab (VenG) 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 VenG treatment.

        Exclusion Criteria:

        - Received intervening treatment for CLL after previous treatment with VenG.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate (ORR) in Cohort 1 after end of combination treatment
Time Frame:9 months
Safety Issue:
Description:Overall response rate 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.

Secondary Outcome Measures

Measure:CR rate in Cohort 1 after end of combination treatment
Time Frame:9 months
Safety Issue:
Description:CR rate is defined as the percentage of participants achieving a best response of CR or CRi
Measure:CR Rate in Cohort 1 after end of treatment
Time Frame:15 months
Safety Issue:
Description:CR rate is defined as the percentage of participants achieving a best response of CR or CRi.
Measure:ORR in Cohort 1 after end of treatment
Time Frame:15 months
Safety Issue:
Description:ORR 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.
Measure:Time to Response (TTR) in Cohort 1
Time Frame:15 months
Safety Issue:
Description:TTR is defined as the time from first dose until first response (PR or better).
Measure:Duration of Response (DOR) in Cohort 1
Time Frame:15 months
Safety Issue:
Description:DOR is defined as the time from first response (PR or better) until progressive disease (PD) or death.
Measure:Time to Next Treatment (TTNT) for CLL in Cohort 1
Time Frame:15 months
Safety Issue:
Description:TTNT is defined as the time from first dose until first dose of a non-protocol anti-CLL therapy.
Measure:Progression-free Survival (PFS) in Cohort 1
Time Frame:15 months
Safety Issue:
Description:PFS is defined as the time from first dose until PD or death.
Measure:Overall Survival (OS) in Cohort 1
Time Frame:15 months
Safety Issue:
Description:OS is defined as the time from first dose until death.
Measure:Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (10^-4) in Cohort 1 after end of combination treatment
Time Frame:9 months
Safety Issue:
Description:Percentage of participants with uMRD rate, measured in peripheral blood.
Measure:Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (10^-4) in Cohort 1 after end of treatment
Time Frame:15 months
Safety Issue:
Description:Percentage of participants with uMRD rate, measured in peripheral blood.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Chronic Lymphocytic Leukemia (CLL)
  • Venetoclax
  • ABT-199
  • Venclexta
  • GDC-0199
  • Obinutuzumab
  • GA101
  • Cancer

Last Updated

May 20, 2021