Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06311227
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Recurrent Hairy Cell Leukemia
  • Recurrent Hairy Cell Leukemia Variant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Lumbar Puncture — PROCEDURE
    Undergo lumbar puncture
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Venetoclax — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Dec 16, 2024
Status verified
Jan 2026
Primary completion
May 20, 2027
Completion
May 20, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (venetoclax)
    Patients receive venetoclax PO 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 CT or MRI and blood sample collection throughout the study. Patients may undergo bone marrow biopsy and/or aspiration on study. Additionally, patients with known or suspected CNS disease undergo lumbar puncture throughout the study.

Primary Outcome Measure

Objective response rate [ Time Frame: Up to 30 days after the last dose ]

Locations (21)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010
Site Public Contact
[email protected]
800-826-4673
Avyakta Kallam (PRINCIPAL_INVESTIGATOR)
City of Hope at Irvine LennarIrvineCalifornia92618
Site Public Contact
877-467-3411
Avyakta Kallam (PRINCIPAL_INVESTIGATOR)
UM Sylvester Comprehensive Cancer Center at AventuraAventuraFlorida33180
Site Public Contact
954-461-2180
Justin M. Watts (PRINCIPAL_INVESTIGATOR)
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral GablesFlorida33146
Site Public Contact
305-243-2647
Justin M. Watts (PRINCIPAL_INVESTIGATOR)
UM Sylvester Comprehensive Cancer Center at Coral SpringsCoral SpringsFlorida33065
Site Public Contact
305-243-2647
Justin M. Watts (PRINCIPAL_INVESTIGATOR)
UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield BeachFlorida33442
Site Public Contact
305-243-2647
Justin M. Watts (PRINCIPAL_INVESTIGATOR)
UM Sylvester Comprehensive Cancer Center at DoralDoralFlorida33166
Site Public Contact
[email protected]
Justin M. Watts (PRINCIPAL_INVESTIGATOR)
UM Sylvester Comprehensive Cancer Center at HollywoodHollywoodFlorida33021
Site Public Contact
305-243-2647
Justin M. Watts (PRINCIPAL_INVESTIGATOR)
UM Sylvester Comprehensive Cancer Center at KendallMiamiFlorida33176
Site Public Contact
305-243-2647
Justin M. Watts (PRINCIPAL_INVESTIGATOR)
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136
Site Public Contact
305-243-2647
Justin M. Watts (PRINCIPAL_INVESTIGATOR)
University of Kansas Cancer CenterKansas CityKansas66160
Site Public Contact
[email protected]
913-588-3671
Joseph Bennett (PRINCIPAL_INVESTIGATOR)
University of Kansas Cancer Center-Overland ParkOverland ParkKansas66210
Site Public Contact
[email protected]
913-588-3671
Joseph Bennett (PRINCIPAL_INVESTIGATOR)
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansas66205
Site Public Contact
[email protected]
913-588-3671
Joseph Bennett (PRINCIPAL_INVESTIGATOR)
University of Maryland/Greenebaum Cancer CenterBaltimoreMaryland21201
Site Public Contact
800-888-8823
Seung Tae Lee (PRINCIPAL_INVESTIGATOR)
NCI - Center for Cancer ResearchBethesdaMaryland20892
Site Public Contact
800-411-1222
Robert J. Kreitman (PRINCIPAL_INVESTIGATOR)
University of Kansas Cancer Center - BriarcliffKansas CityMissouri64116
Site Public Contact
913-588-3671
Joseph Bennett (PRINCIPAL_INVESTIGATOR)
University of Kansas Cancer Center - NorthKansas CityMissouri64154
Site Public Contact
[email protected]
913-588-3671
Joseph Bennett (PRINCIPAL_INVESTIGATOR)
University of Kansas Cancer Center - Lee's SummitLee's SummitMissouri64064
Site Public Contact
[email protected]
913-588-3671
Joseph Bennett (PRINCIPAL_INVESTIGATOR)
University of Cincinnati Cancer Center-UC Medical CenterCincinnatiOhio45219-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Cincinnati Cancer Center-West ChesterWest ChesterOhio45069-

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