RecruitingPhase 2NCT06311227

Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia

A Phase 2 Study of Venetoclax in Relapsed Classic or Variant Hairy Cell Leukemia

Sponsor

National Cancer Institute (NCI)

Enrollment

20 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

Recurrent Hairy Cell Leukemia Recurrent Hairy Cell Leukemia Variant

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests venetoclax — a targeted drug that causes cancer cells to self-destruct — in patients with relapsed hairy cell leukemia (HCL), a rare, slow-growing blood cancer. It is aimed at patients whose cancer has come back after treatment with standard drugs (purine analogs) and who are not eligible for or have not responded to BRAF-targeted therapy. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with hairy cell leukemia or a related variant that has returned after purine analog chemotherapy - You are not eligible for or have not responded to BRAF inhibitor therapy - You have not previously received venetoclax - Your liver, kidney, and blood counts are within acceptable ranges - If you have HIV, it must be well controlled on antiretroviral therapy **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have active, uncontrolled infections - You have other active cancers - Your organ function does not meet the required minimums Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREComputed Tomography

Undergo CT scan

PROCEDURELumbar Puncture

Undergo lumbar puncture

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGVenetoclax

Given PO

Locations(21)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Springs

Coral Springs, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

UM Sylvester Comprehensive Cancer Center at Doral

Doral, Florida, United States

UM Sylvester Comprehensive Cancer Center at Hollywood

Hollywood, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

NCI - Center for Cancer Research

Bethesda, Maryland, United States

University of Kansas Cancer Center - Briarcliff

Kansas City, Missouri, United States

University of Kansas Cancer Center - North

Kansas City, Missouri, United States

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06311227

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