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Trial Title: Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia

NCT ID: NCT06311227

Condition: Recurrent Hairy Cell Leukemia
Recurrent Hairy Cell Leukemia Variant

Conditions: Official terms:
Leukemia
Leukemia, Hairy Cell
Recurrence
Venetoclax

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Biospecimen Collection
Description: Undergo blood sample collection
Arm group label: Treatment (venetoclax)

Other name: Biological Sample Collection

Other name: Biospecimen Collected

Other name: Specimen Collection

Intervention type: Procedure
Intervention name: Bone Marrow Aspiration
Description: Undergo bone marrow aspiration
Arm group label: Treatment (venetoclax)

Intervention type: Procedure
Intervention name: Bone Marrow Biopsy
Description: Undergo bone marrow biopsy
Arm group label: Treatment (venetoclax)

Other name: Biopsy of Bone Marrow

Other name: Biopsy, Bone Marrow

Intervention type: Procedure
Intervention name: Computed Tomography
Description: Undergo CT scan
Arm group label: Treatment (venetoclax)

Other name: CAT

Other name: CAT Scan

Other name: Computed Axial Tomography

Other name: Computerized Axial Tomography

Other name: Computerized axial tomography (procedure)

Other name: Computerized Tomography

Other name: Computerized Tomography (CT) scan

Other name: CT

Other name: CT Scan

Other name: tomography

Intervention type: Procedure
Intervention name: Magnetic Resonance Imaging
Description: Undergo MRI
Arm group label: Treatment (venetoclax)

Other name: Magnetic Resonance

Other name: Magnetic Resonance Imaging (MRI)

Other name: Magnetic resonance imaging (procedure)

Other name: Magnetic Resonance Imaging Scan

Other name: Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

Other name: MR

Other name: MR Imaging

Other name: MRI

Other name: MRI Scan

Other name: MRIs

Other name: NMR Imaging

Other name: NMRI

Other name: Nuclear Magnetic Resonance Imaging

Other name: sMRI

Other name: Structural MRI

Intervention type: Drug
Intervention name: Venetoclax
Description: Given PO
Arm group label: Treatment (venetoclax)

Other name: ABT 199

Other name: ABT-0199

Other name: ABT-199

Other name: ABT199

Other name: GDC 0199

Other name: GDC-0199

Other name: GDC0199

Other name: RG7601

Other name: Venclexta

Other name: Venclyxto

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.

Detailed description: PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR) of venetoclax. SECONDARY OBJECTIVES: I. To determine the complete remission (CR) and minimal residual disease (MRD)-negative CR rates of venetoclax in relapsed hairy cell leukemia/hairy cell leukemia variant (HCL/HCLv). II. To determine the rates of MRD-negative by blood flow cytometry with venetoclax. III. To determine the safety of venetoclax in relapsed HCL/HCLv. IV. To determine the response and CR duration and MRD-negative survival in relapsed HCL/HCLv receiving venetoclax. EXPLORATORY OBJECTIVES: I. To correlate response to TP53 mutations and other mutations, particularly for BRAF wild-type (WT) relapsed HCL/HCLv. II. To perform whole exome sequencing (WES) of relapsed HCL/HCLv samples to look for mutations, to correlate with response. OUTLINE: Patients receive venetoclax orally (PO) once daily (QD) on days 1-28 of each cycle. Treatment repeats every 28 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) and blood sample collection throughout the study. Patients may undergo bone marrow biopsy and/or aspiration on study. After completion of study treatment, patients are followed up at 30 days.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Patients must have histologically or cytologically confirmed HCL/HCLv after purine analog therapy who are relapsed from or are ineligible for BRAF therapy and have not received prior venetoclax - Age ≥ 18 years - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%) - Total bilirubin ≤ 3 x institutional upper limit of normal (ULN) unless consistent with Gilbert's (ration between total and direct bilirubin > 5) - Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 × institutional ULN - Serum creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 45 mL/min/1.73m^2 - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated - Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial - Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better - Patients must have had no HCL/HCLv treatment for ≥ 4 weeks prior to enrollment, and those with treatment > 4 weeks prior to enrollment must not be responding to their last treatment with decreasing tumor burden or improving drug-related cytopenias - Patients must have a need for treatment due to absolute neutrophil count (ANC) < 1/nL, hemoglobin (Hgb) < 10g/dL, platelets (Plt) < 100/nL, symptomatic splenomegaly, enlarging HCL mass > 2cm in short axis, enlarging HCL mass > 0.5 cm in the central nervous system (CNS) in short axis, or leukemic count > 5/nL - The effects of venetoclax on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during treatment and for 30 days after the last dose of venetoclax. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception during treatment and for 30 days after the last dose of venetoclax - Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants - Ability and willingness to swallow pills Exclusion Criteria: - Patients who have received prior venetoclax - Patients who are receiving any other investigational agents - History of allergic reactions attributed to compounds of similar chemical or biologic composition to venetoclax - Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous - Pregnant women are excluded from this study because venetoclax is a B-cell lymphoma-2 (BCL-2) inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax - Malabsorption syndrome or other conditions that would interfere with intestinal absorption - Live attenuated vaccines should not be administered within 4 weeks prior to, during, or 30 days after study treatment and recovery has occurred

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: National Cancer Institute LAO

Address:
City: Bethesda
Zip: 20892
Country: United States

Status: Recruiting

Contact:
Last name: Robert J. Kreitman
Email: kreitmar@mail.nih.gov

Investigator:
Last name: Robert J. Kreitman
Email: Principal Investigator

Facility:
Name: University of Cincinnati Cancer Center-UC Medical Center

Address:
City: Cincinnati
Zip: 45219
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 513-584-7698
Email: cancer@uchealth.com

Investigator:
Last name: Zulfa Omer
Email: Principal Investigator

Facility:
Name: Ohio State University Comprehensive Cancer Center

Address:
City: Columbus
Zip: 43210
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-293-5066
Email: Jamesline@osumc.edu

Investigator:
Last name: Kerry A. Rogers
Email: Principal Investigator

Facility:
Name: University of Cincinnati Cancer Center-West Chester

Address:
City: West Chester
Zip: 45069
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 513-584-7698
Email: cancer@uchealth.com

Investigator:
Last name: Zulfa Omer
Email: Principal Investigator

Start date: February 14, 2025

Completion date: May 20, 2027

Lead sponsor:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: National Cancer Institute (NCI)

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06311227

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