Actively Recruiting
Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
20
Participants Needed
21
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial tests how well venetoclax works in treating patients with hairy cell leukemia that has come back after a period of improvement (relapsed). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival.
CONDITIONS
Official Title
Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have confirmed hairy cell leukemia or hairy cell leukemia variant after purine analog therapy and be relapsed or ineligible for BRAF therapy with no prior venetoclax treatment
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (Karnofsky score 60% or higher)
- Total bilirubin less than or equal to 3 times the institutional upper limit of normal unless consistent with Gilbert's syndrome
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels less than or equal to 3 times the institutional upper limit of normal
- Serum creatinine less than or equal to 2.0 mg/dL or creatinine clearance of 45 mL/min/1.73m2 or greater
- HIV-infected patients on effective therapy with undetectable viral load within 6 months are eligible
- Patients with chronic hepatitis B must have undetectable viral load on suppressive therapy if needed
- Patients with hepatitis C must be treated and cured or have undetectable viral load if on treatment
- Patients with prior or concurrent malignancies that do not interfere with study safety or efficacy may participate
- Patients with cardiac disease should have New York Heart Association Functional Classification class 2B or better
- No hairy cell leukemia treatment within 4 weeks prior to enrollment, and those treated more than 4 weeks prior must not be responding to last treatment
- Patients must require treatment due to specific blood counts, symptomatic splenomegaly, tumor size, or disease progression criteria
- Women of child-bearing potential and men must agree to use effective contraception during treatment and for 30 days after the last dose
- Ability to understand and sign informed consent
- Ability and willingness to swallow pills
You will not qualify if you...
- Prior treatment with venetoclax
- Receiving any other investigational agents
- History of allergic reactions to compounds similar to venetoclax
- Uncontrolled illness or other significant conditions making participation unsafe
- Pregnancy or breastfeeding
- Malabsorption syndrome or conditions interfering with drug absorption
- Receipt of live attenuated vaccines within 4 weeks before, during, or 30 days after study treatment and recovery
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Actively Recruiting
3
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States, 33180
Actively Recruiting
4
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Actively Recruiting
5
UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida, United States, 33065
Actively Recruiting
6
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
7
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, United States, 33166
Actively Recruiting
8
UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida, United States, 33021
Actively Recruiting
9
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
10
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States, 33176
Actively Recruiting
11
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
12
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
13
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
14
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
15
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892
Actively Recruiting
16
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, United States, 64116
Actively Recruiting
17
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
Actively Recruiting
18
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
19
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Suspended
20
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Suspended
21
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Suspended
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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