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 120 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 Genders
- 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, Arizona 85704
Clovis, California 93611
Los Angeles, California 90067
Aurora, Colorado 80012
New Haven, Connecticut 06510
Gainesville, Florida 32608
Jacksonville, Florida 32256
Orange City, Florida 32763
Saint Petersburg, Florida 33709
Springfield, Illinois 62702-3749
Dyer, Indiana 46311
Des Moines, Iowa 50314-3017
Shreveport, Louisiana 71103
Bethesda, Maryland 20817
Silver Spring, Maryland 20904
Kansas City, Missouri 64111
Cleveland, Ohio 44195
Tulsa, Oklahoma 74146
Eugene, Oregon 97401
Providence, Rhode Island 02903
Austin, Texas 78705
Dallas, Texas 75235
Gainesville, Virginia 20155-3257
Olympia, Washington 98506
Site Coordinator
360-413-8880 opt 4
Tacoma, Washington 98405
Morgantown, West Virginia 26506
Rio Piedras, Puerto Rico 00935
More Details
- NCT ID
- NCT06428019
- Status
- Recruiting
- Sponsor
- AbbVie