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NCT06311227 · ClinicalTrials.gov registry record · Phase 2

Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia

A Phase 2 study of Recurrent Hairy Cell Leukemia and Recurrent Hairy Cell Leukemia Variant, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 2
Development phase
20
Enrollment target
20
Study locations

NCT06311227: Recruiting Phase 2 study of Recurrent Hairy Cell Leukemia and Recurrent Hairy Cell Leukemia Variant, sponsored by National Cancer Institute (NCI).

NCT06311227 is a Phase 2 study of Recurrent Hairy Cell Leukemia and Recurrent Hairy Cell Leukemia Variant that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 20 participants, below the 79-participant average among 4 other Recurrent Hairy Cell Leukemia trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06311227, a Phase 2 study of Recurrent Hairy Cell Leukemia and Recurrent Hairy Cell Leukemia Variant, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 2
Development phase
20 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Will be determined with 95% confidence intervals for each group.

Conditions Studied

Recurrent Hairy Cell Leukemia Recurrent Hairy Cell Leukemia Variant

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Bone Marrow Aspiration
  • PROCEDURE Bone Marrow Biopsy
  • PROCEDURE Computed Tomography
  • PROCEDURE Lumbar Puncture

Study Locations (20)

Florida

  • UM Sylvester Comprehensive Cancer Center at Aventura - Aventura
  • UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
  • UM Sylvester Comprehensive Cancer Center at Coral Springs - Coral Springs
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
  • UM Sylvester Comprehensive Cancer Center at Doral - Doral
  • UM Sylvester Comprehensive Cancer Center at Hollywood - Hollywood
  • University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
  • UM Sylvester Comprehensive Cancer Center at Kendall - Miami

Kansas

  • University of Kansas Cancer Center - Kansas City
  • University of Kansas Cancer Center-Overland Park - Overland Park
  • University of Kansas Hospital-Westwood Cancer Center - Westwood

Missouri

  • University of Kansas Cancer Center - Briarcliff - Kansas City
  • University of Kansas Cancer Center - North - Kansas City
  • University of Kansas Cancer Center - Lee's Summit - Lee's Summit

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • City of Hope at Irvine Lennar - Irvine

Maryland

  • University of Maryland/Greenebaum Cancer Center - Baltimore
  • NCI - Center for Cancer Research - Bethesda

Ohio

  • University of Cincinnati Cancer Center-UC Medical Center - Cincinnati
  • Ohio State University Comprehensive Cancer Center - Columbus

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2024-12-16
Est. Completion 2027-05-20
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What NCT06311227 shows while recruiting

NCT06311227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 79-participant average among 4 other Recurrent Hairy Cell Leukemia trials with a reported enrollment target (75% lower).

The record links to 2 conditions, with Recurrent Hairy Cell Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06311227 names 20 study sites across 6 states, led by Florida, Kansas, Missouri.

Frequently Asked Questions

What is clinical trial NCT06311227 about?

NCT06311227 is a clinical study titled "Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia". 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...

What is the current status of trial NCT06311227?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2024-12-16. Estimated completion is 2027-05-20.

What conditions does trial NCT06311227 study?

This clinical trial studies the following conditions: Recurrent Hairy Cell Leukemia, Recurrent Hairy Cell Leukemia Variant.

What interventions are being tested in trial NCT06311227?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Lumbar Puncture (PROCEDURE).

Who is sponsoring clinical trial NCT06311227?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06311227 being conducted?

This trial has 20 study locations across California, Florida, Kansas, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT06311227

Source: ClinicalTrials.gov NCT06311227, the US trial registry maintained by the National Library of Medicine. NCT06311227 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.