Back to resultsStudy 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) (ReVenG)
Primary Purpose
Chronic Lymphocytic Leukemia (CLL)
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Venetoclax
Obinutuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia (CLL) focused on measuring Chronic Lymphocytic Leukemia (CLL), Venetoclax, ABT-199, Venclexta, GDC-0199, Obinutuzumab, Gazyva, GA101, Cancer, ReVenG
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.
Sites / Locations
- Moores Cancer Center at UC San Diego /ID# 230157Recruiting
- Des Moines Oncology Research Association /ID# 232606Recruiting
- Dana-Farber Cancer Institute /ID# 230061Recruiting
- Henry Ford Health System /ID# 230268Recruiting
- St. Luke's Hospital of Duluth /ID# 250021Recruiting
- Summit Medical Group-Florham Park /ID# 244782Recruiting
- Novant Health Presbyterian Medical Center /ID# 230201Recruiting
- Novant Health Forsyth Medical Center /ID# 249533Recruiting
- University of Wisconsin-Madiso /ID# 232612Recruiting
- Royal Adelaide Hospital /ID# 229898Recruiting
- Northern Hospital Epping /ID# 229847Recruiting
- Peter MacCallum Cancer Ctr /ID# 254634Recruiting
- Universitaetsklinikum St. Poelten /ID# 243493Recruiting
- Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516Recruiting
- Medizinische Universitaet Wien /ID# 230013Recruiting
- Klinik Ottakring /ID# 230019Recruiting
- Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 230015Recruiting
- Hanusch Krankenhaus /ID# 230010Recruiting
- Hospital de Clinicas de Porto Alegre /ID# 243657Recruiting
- Hospital Nove de Julho /ID# 243658Recruiting
- Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659Recruiting
- MHAT Hristo Botev /ID# 229687Recruiting
- Stauferklinikum Schwaebisch Gmuend /ID# 230176Recruiting
- Universitaetsklinikum Ulm /ID# 230164Recruiting
- VK&K Studien GbR /ID# 230198Recruiting
- Universitaetsklinikum Koeln /ID# 230296Recruiting
- Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 230186Recruiting
- DIAKO Ev. Diakonie-Krankenhaus gemeinnuetzige GmbH /ID# 230238Recruiting
- Universitaetsklinikum Essen /ID# 230181Recruiting
- Universitaetsklinikum Halle (Saale) /ID# 245350Recruiting
- OncoResearch Lerchenfeld GmbH /ID# 230191Recruiting
- Muenchen Klinik Schwabing /ID# 230197Recruiting
- Bruederkrankenhaus St. Josef Paderborn /ID# 230177Recruiting
- Universitaetsmedizin Rostock /ID# 230190Recruiting
- The Chaim Sheba Medical Center /ID# 243219Recruiting
- Tel Aviv Sourasky Medical Center /ID# 243218Recruiting
- Hadassah /ID# 245059Recruiting
- Rabin Medical Center /ID# 243220Recruiting
- Azienda Ospedaliera Santa Maria Terni /ID# 229442Recruiting
- A.O.U. Citta della Salute e della Scienza di Torino /ID# 229504Recruiting
- Institutul Clinic Fundeni /ID# 241614Recruiting
- Hospital Universitario de la Princesa /ID# 229665Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1 - venetoclax + obinutuzumab
Cohort 2 - venetoclax + obinutuzumab
Arm Description
Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles.
Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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 to Response (TTR) in Cohort 1
TTR is defined as the time from first dose until first response (PR or better).
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 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.
Progression-free Survival (PFS) in Cohort 1
PFS is defined as the time from first dose until PD or death.
Overall Survival (OS) in Cohort 1
OS is defined as the time from first dose until death.
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.
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.
Full Information
NCT ID
NCT04895436
First Posted
May 19, 2021
Last Updated
October 23, 2023
Sponsor
AbbVie
Collaborators
F. Hoffmann-La Roche Ltd; German CLL Study Group (GCLLSG); Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT04895436
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)
Acronym
ReVenG
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
February 22, 2025 (Anticipated)
Study Completion Date
June 11, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
F. Hoffmann-La Roche Ltd; German CLL Study Group (GCLLSG); Dana-Farber Cancer Institute
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia (CLL)
Keywords
Chronic Lymphocytic Leukemia (CLL), Venetoclax, ABT-199, Venclexta, GDC-0199, Obinutuzumab, Gazyva, GA101, Cancer, ReVenG
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 - venetoclax + obinutuzumab
Arm Type
Experimental
Arm Description
Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles.
Arm Title
Cohort 2 - venetoclax + obinutuzumab
Arm Type
Experimental
Arm Description
Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles.
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
Venclexta, ABT-199, GDC-0199
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
Obinutuzumab
Other Intervention Name(s)
GA101, Gazyva
Intervention Description
Intravenous (IV) infusion
Primary Outcome Measure Information:
Title
Overall response (OR) in Cohort 1 after end of combination treatment
Description
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 Outcome Measure Information:
Title
OR in Cohort 1 after end of combination treatment
Description
OR rate is defined as the percentage of participants achieving a best response of CR or CRi
Time Frame
9 months
Title
OR in Cohort 1 after end of treatment
Description
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
Title
Time to Response (TTR) in Cohort 1
Description
TTR is defined as the time from first dose until first response (PR or better).
Time Frame
15 months
Title
Duration of Response (DOR) in Cohort 1
Description
DOR is defined as the time from first response (PR or better) until progressive disease (PD) or death.
Time Frame
15 months
Title
Time to Next Treatment (TTNT) for CLL in Cohort 1
Description
TTNT is defined as the time from first dose until first dose of a non-protocol anti-CLL therapy.
Time Frame
15 months
Title
Progression-free Survival (PFS) in Cohort 1
Description
PFS is defined as the time from first dose until PD or death.
Time Frame
15 months
Title
Overall Survival (OS) in Cohort 1
Description
OS is defined as the time from first dose until death.
Time Frame
15 months
Title
Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of combination treatment
Description
Percentage of participants with uMRD rate, measured in peripheral blood.
Time Frame
9 months
Title
Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of treatment
Description
Percentage of participants with uMRD rate, measured in peripheral blood.
Time Frame
15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 + 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Moores Cancer Center at UC San Diego /ID# 230157
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Name
Des Moines Oncology Research Association /ID# 232606
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1423
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana-Farber Cancer Institute /ID# 230061
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Health System /ID# 230268
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Luke's Hospital of Duluth /ID# 250021
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Individual Site Status
Recruiting
Facility Name
Summit Medical Group-Florham Park /ID# 244782
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932-1049
Country
United States
Individual Site Status
Recruiting
Facility Name
Novant Health Presbyterian Medical Center /ID# 230201
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
Novant Health Forsyth Medical Center /ID# 249533
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Wisconsin-Madiso /ID# 232612
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Name
Royal Adelaide Hospital /ID# 229898
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Northern Hospital Epping /ID# 229847
City
Epping
State/Province
Victoria
ZIP/Postal Code
3076
Country
Australia
Individual Site Status
Recruiting
Facility Name
Peter MacCallum Cancer Ctr /ID# 254634
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum St. Poelten /ID# 243493
City
Sankt Poelten
State/Province
Niederoesterreich
ZIP/Postal Code
3100
Country
Austria
Individual Site Status
Recruiting
Facility Name
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516
City
Linz
State/Province
Oberoesterreich
ZIP/Postal Code
4010
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medizinische Universitaet Wien /ID# 230013
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Klinik Ottakring /ID# 230019
City
Vienna
State/Province
Wien
ZIP/Postal Code
1160
Country
Austria
Individual Site Status
Recruiting
Facility Name
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 230015
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Hanusch Krankenhaus /ID# 230010
City
Wien
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Name
Hospital de Clinicas de Porto Alegre /ID# 243657
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Nove de Julho /ID# 243658
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01409-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659
City
Sao Paulo
ZIP/Postal Code
01236-030
Country
Brazil
Individual Site Status
Recruiting
Facility Name
MHAT Hristo Botev /ID# 229687
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Stauferklinikum Schwaebisch Gmuend /ID# 230176
City
Mutlangen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
73557
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Ulm /ID# 230164
City
Ulm
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
VK&K Studien GbR /ID# 230198
City
Landshut
State/Province
Bayern
ZIP/Postal Code
84036
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Koeln /ID# 230296
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 230186
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
DIAKO Ev. Diakonie-Krankenhaus gemeinnuetzige GmbH /ID# 230238
City
Bremen
ZIP/Postal Code
28239
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Essen /ID# 230181
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Halle (Saale) /ID# 245350
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
OncoResearch Lerchenfeld GmbH /ID# 230191
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Muenchen Klinik Schwabing /ID# 230197
City
Muenchen
ZIP/Postal Code
80804
Country
Germany
Individual Site Status
Recruiting
Facility Name
Bruederkrankenhaus St. Josef Paderborn /ID# 230177
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsmedizin Rostock /ID# 230190
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Individual Site Status
Recruiting
Facility Name
The Chaim Sheba Medical Center /ID# 243219
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel Aviv Sourasky Medical Center /ID# 243218
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah /ID# 245059
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center /ID# 243220
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Santa Maria Terni /ID# 229442
City
Terni
ZIP/Postal Code
05100
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O.U. Citta della Salute e della Scienza di Torino /ID# 229504
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Institutul Clinic Fundeni /ID# 241614
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de la Princesa /ID# 229665
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing 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/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.rxabbvie.com/
Description
Related info
Learn more about this trial
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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