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Trial Title:
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)
NCT ID:
NCT06428019
Condition:
Chronic Lymphocytic Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Venetoclax
Obinutuzumab
Acalabrutinib
Conditions: Keywords:
Chronic Lymphocytic Leukemia
CLL
Venetoclax
ABT-199
Obinutuzumab
Acalabrutinib
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Oral: Tablet
Arm group label:
Arm A: Venetoclax + Obinutuzumab
Arm group label:
Arm B: Venetoclax + Acalabrutinib
Arm group label:
Arm C: Venetoclax + Acalabrutinib
Arm group label:
Arm D: Venetoclax + Acalabrutinib
Other name:
ABT-199
Intervention type:
Drug
Intervention name:
Acalabrutinib
Description:
Oral: Tablet
Arm group label:
Arm B: Venetoclax + Acalabrutinib
Arm group label:
Arm C: Venetoclax + Acalabrutinib
Arm group label:
Arm D: Venetoclax + Acalabrutinib
Intervention type:
Drug
Intervention name:
Obinutuzumab
Description:
Intravenous Infusion
Arm group label:
Arm A: Venetoclax + Obinutuzumab
Summary:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Yale University School of Medicine /ID# 266224
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 266713
Address:
City:
Jacksonville
Zip:
32256
Country:
United States
Status:
Recruiting
Facility:
Name:
Comprehensive Hematology Oncology /ID# 267644
Address:
City:
Saint Petersburg
Zip:
33709
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwest Cancer Center - Dyer Clinic /ID# 268478
Address:
City:
Dyer
Zip:
46311
Country:
United States
Status:
Recruiting
Facility:
Name:
Mission Cancer and Blood /ID# 267206
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Status:
Recruiting
Facility:
Name:
American Oncology Partners of Maryland /ID# 266445
Address:
City:
Bethesda
Zip:
20817
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Texas - Southwestern Medical Center /ID# 266528
Address:
City:
Dallas
Zip:
75235
Country:
United States
Status:
Recruiting
Facility:
Name:
Vista Oncology - East Olympia /ID# 267337
Address:
City:
Olympia
Zip:
98506
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Coordinator
Phone:
360-413-8880 opt 4
Facility:
Name:
Northwest Medical Specialties Tacoma /ID# 266327
Address:
City:
Tacoma
Zip:
98405
Country:
United States
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital /ID# 267017
Address:
City:
Taipei City
Zip:
100
Country:
Taiwan
Status:
Recruiting
Start date:
August 5, 2024
Completion date:
October 21, 2026
Lead sponsor:
Agency:
AbbVie
Agency class:
Industry
Source:
AbbVie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06428019
https://www.abbvieclinicaltrials.com/study/?id=M24-287
