A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Purpose
Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed. Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 170 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide. Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months. 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
- Chronic Lymphocytic Leukemia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Diagnosis of documented, previously untreated, chronic lymphocytic leukemia (CLL) requiring treatment according to the 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria and have a life expectancy of > 6 months. - Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLL criteria for treatment will also be equally considered as CLL for eligibility, screening, treatment and evaluation. - Eastern Cooperative Oncology Group (ECOG) performance status <= 2. - Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening, unless cytopenia is due to marrow involvement of CLL as listed in the protocol. - Creatinine clearance (CrCl) >= 30 mL/min using the Cockcroft-Gault formula are eligible for inclusion.
Exclusion Criteria
- Active/uncontrolled infection, no Richter's transformation, no active immune thrombocytopenia.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A: Venetoclax + Obinutuzumab |
Participants will receive venetoclax in combination with obinutuzumab, with a 5 week venetoclax ramp up. |
|
|
Experimental Arm B: Venetoclax + Acalabrutinib |
Participants will receive venetoclax in combination with acalabrutinib, with a 5 week venetoclax ramp up. |
|
|
Experimental Arm C: Venetoclax + Acalabrutinib |
Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up A. |
|
|
Experimental Arm D: Venetoclax + Acalabrutinib |
Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up B. |
|
Recruiting Locations
Tucson 5318313, Arizona 5551752 85704
Tucson 5318313, Arizona 5551752 85723
Clovis 5338122, California 5332921 93611
Los Angeles 5368361, California 5332921 90067
Aurora 5412347, Colorado 5417618 80012
New Haven 4839366, Connecticut 4831725 06510
Gainesville 4156404, Florida 4155751 32608
Jacksonville 4160021, Florida 4155751 32256
Orange City 4167055, Florida 4155751 32763
St. Petersburg 4171563, Florida 4155751 33709
Springfield 4250542, Illinois 4896861 62702
Dyer 4919820, Indiana 4921868 46311
Des Moines 4853828, Iowa 4862182 50314-3017
Shreveport 4341513, Louisiana 4331987 71103
Bethesda 4348599, Maryland 4361885 20817
Silver Spring 4369596, Maryland 4361885 20904
Worcester 4956184, Massachusetts 6254926 01605
Detroit 4990729, Michigan 5001836 48202
Kansas City 4393217, Missouri 4398678 64111
New York 5128581, New York 5128638 10029
Charlotte 4460243, North Carolina 4482348 28204-2963
Winston-Salem 4499612, North Carolina 4482348 27157
Cleveland 5150529, Ohio 5165418 44195
Tulsa 4553433, Oklahoma 4544379 74146
Eugene 5725846, Oregon 5744337 97401
Providence 5224151, Rhode Island 5224323 02903
Austin 4671654, Texas 4736286 78705
Dallas 4684888, Texas 4736286 75235
Gainesville 4760363, Virginia 6254928 20155-3257
Olympia 5805687, Washington 5815135 98506
Site Coordinator
360-413-8880 opt 4
Tacoma 5812944, Washington 5815135 98405
Morgantown 4815352, West Virginia 4826850 26506
Rio Piedras 4829037, Puerto Rico 00935
More Details
- NCT ID
- NCT06428019
- Status
- Recruiting
- Sponsor
- AbbVie