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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)

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ClinicalTrials.gov Identifier: NCT04895436
Recruitment Status : Recruiting
First Posted : May 20, 2021
Last Update Posted : February 3, 2023
Sponsor:
Collaborator:
F. Hoffmann-La Roche Ltd; German CLL Study Group (GCLLSG); Dana-Farber Cancer Institute
Information provided by (Responsible Party):
AbbVie

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia (CLL) Drug: Venetoclax Drug: Obinutuzumab Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 28, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : June 11, 2026


Arm Intervention/treatment
Experimental: Cohort 1 - venetoclax + obinutuzumab
Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles.
Drug: Venetoclax
Oral tablet
Other Names:
  • Venclexta
  • ABT-199
  • GDC-0199

Drug: Obinutuzumab
Intravenous (IV) infusion
Other Name: GA101

Experimental: Cohort 2 - venetoclax + obinutuzumab
Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles.
Drug: Venetoclax
Oral tablet
Other Names:
  • Venclexta
  • ABT-199
  • GDC-0199

Drug: Obinutuzumab
Intravenous (IV) infusion
Other Name: GA101




Primary Outcome Measures :
  1. Overall response rate (ORR) in Cohort 1 after end of combination treatment [ Time Frame: 9 months ]
    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 :
  1. CR rate in Cohort 1 after end of combination treatment [ Time Frame: 9 months ]
    CR rate is defined as the percentage of participants achieving a best response of CR or CRi

  2. CR Rate in Cohort 1 after end of treatment [ Time Frame: 15 months ]
    CR rate is defined as the percentage of participants achieving a best response of CR or CRi.

  3. ORR in Cohort 1 after end of treatment [ Time Frame: 15 months ]
    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.

  4. Time to Response (TTR) in Cohort 1 [ Time Frame: 15 months ]
    TTR is defined as the time from first dose until first response (PR or better).

  5. Duration of Response (DOR) in Cohort 1 [ Time Frame: 15 months ]
    DOR is defined as the time from first response (PR or better) until progressive disease (PD) or death.

  6. Time to Next Treatment (TTNT) for CLL in Cohort 1 [ Time Frame: 15 months ]
    TTNT is defined as the time from first dose until first dose of a non-protocol anti-CLL therapy.

  7. Progression-free Survival (PFS) in Cohort 1 [ Time Frame: 15 months ]
    PFS is defined as the time from first dose until PD or death.

  8. Overall Survival (OS) in Cohort 1 [ Time Frame: 15 months ]
    OS is defined as the time from first dose until death.

  9. Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (10^-4) in Cohort 1 after end of combination treatment [ Time Frame: 9 months ]
    Percentage of participants with uMRD rate, measured in peripheral blood.

  10. Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (10^-4) in Cohort 1 after end of treatment [ Time Frame: 15 months ]
    Percentage of participants with uMRD rate, measured in peripheral blood.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04895436


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
Show Show 53 study locations
Sponsors and Collaborators
AbbVie
F. Hoffmann-La Roche Ltd; German CLL Study Group (GCLLSG); Dana-Farber Cancer Institute
Investigators
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Study Director: ABBVIE INC. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04895436    
Other Study ID Numbers: M20-356
2021-001037-39 ( EudraCT Number )
First Posted: May 20, 2021    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
URL: https://vivli.org/ourmember/abbvie/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AbbVie:
Chronic Lymphocytic Leukemia (CLL)
Venetoclax
ABT-199
Venclexta
GDC-0199
Obinutuzumab
GA101
Cancer
ReVenG
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Venetoclax
Obinutuzumab
Antineoplastic Agents
Antineoplastic Agents, Immunological