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)

Part of paid clinical trials in La Jolla, California.

Sponsor
AbbVie
Study ID
NCT04895436
Phase
PHASE2
Status
Recruiting
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Conditions

  • Chronic Lymphocytic Leukemia (CLL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Oral tablet
  • Obinutuzumab — DRUG
    Intravenous (IV) infusion

Study Details

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.

Key Dates

Start date
Mar 28, 2022
Status verified
Feb 2026
Primary completion
Nov 30, 2026
Completion
Jan 31, 2029

Study Design

Enrollment
75 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 - venetoclax + obinutuzumab
    Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles.
  • Experimental: Cohort 2 - venetoclax + obinutuzumab
    Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles.

Primary Outcome Measure

Overall response (OR) in Cohort 1 after end of combination treatment [ Time Frame: 9 months ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Moores Cancer Center at UC San Diego /ID# 230157La JollaCalifornia92093-
Winship Cancer Institute of Emory University /ID# 230643AtlantaGeorgia30322-
Des Moines Oncology Research Association /ID# 232606Des MoinesIowa50309-1423-
Dana-Farber Cancer Institute /ID# 230061BostonMassachusetts02215-
Henry Ford Hospital /ID# 230268DetroitMichigan48202-
St. Lukes Hospital of Duluth /ID# 250021DuluthMinnesota55805-
Hattiesburg Clinic /ID# 233443HattiesburgMississippi39401-
Summit Medical Group-Florham Park /ID# 244782Florham ParkNew Jersey07932-1049-
Regional Cancer Care Associates /ID# 244620HackensackNew Jersey07601-7015-
University of North Carolina /ID# 233313Chapel HillNorth Carolina27514-
Novant Health Presbyterian Medical Center /ID# 230201CharlotteNorth Carolina28204-
Novant Health Forsyth Medical Center /ID# 249533Winston-SalemNorth Carolina27103-
The Ohio State University /ID# 230439ColumbusOhio43210-
Pennsylvania Oncology Hematolo /ID# 249637PhiladelphiaPennsylvania19106-
University of Wisconsin-Madiso /ID# 232612MadisonWisconsin53705-

Find similar trials in La Jolla, CA

By research site
Moores Cancer Center at UC San Diego· La Jolla, CAWinship Cancer Institute of Emory University· Atlanta, GADes Moines Oncology Research Association· Des Moines, IADana-Farber Cancer Institute· Boston, MAHenry Ford Hospital· Detroit, MISt. Lukes Hospital of Duluth· Duluth, MN

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