Venetoclax for Treating Patients with Relapsed Hairy Cell Leukemia

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06311227

Provider View

This phase II clinical trial is studying how well the drug venetoclax works in patients whose hairy cell leukemia has returned after a period of improvement. Venetoclax may help stop cancer cells from growing by blocking a protein they need to survive.

Patient Parameters

Program Overview

The main goal of this study is to see how effective venetoclax is in treating patients with hairy cell leukemia that has come back. Venetoclax is a type of medication that may help stop cancer cells from growing by blocking a protein called Bcl-2, which is important for their survival. Patients will take venetoclax by mouth once a day for 28 days in each cycle, and this can continue for up to 19 cycles unless the disease progresses or side effects become too severe. Throughout the study, patients will have scans and blood tests, and may also have bone marrow tests. After finishing the treatment, patients will have a follow-up visit 30 days later.

Description

The primary aim of this study is to determine how well venetoclax works in patients with relapsed hairy cell leukemia. Researchers will look at how many patients respond to the treatment and how many achieve complete remission, meaning no signs of cancer. They will also check if the cancer is undetectable in the blood after treatment and how long these responses last. Safety is another important aspect, as researchers will monitor any side effects of venetoclax. Additionally, the study will explore if certain genetic mutations affect how well patients respond to the treatment.

Patients will take venetoclax by mouth once a day for 28 days in each cycle, and this can continue for up to 19 cycles unless the disease progresses or side effects become too severe. Throughout the study, patients will have scans and blood tests, and may also have bone marrow tests. After finishing the treatment, patients will have a follow-up visit 30 days later.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of hairy cell leukemia that has returned after previous treatment and cannot be treated with BRAF therapy.
  • Must be 18 years or older.
  • Must be in relatively good health, with a performance status that allows for daily activities.
  • Must have acceptable liver and kidney function based on blood tests.
  • HIV-positive patients can participate if their viral load is undetectable.
  • Patients with hepatitis B or C must have controlled or treated infections.
  • Must not have received any treatment for hairy cell leukemia in the last 4 weeks.
  • Must need treatment due to low blood counts, symptoms, or growing cancer masses.
  • Women and men must agree to use effective birth control during treatment and for 30 days after the last dose.
  • Must be able to understand and sign a consent form.
  • Must be able to swallow pills.

Exclusion Criteria

  • Cannot have taken venetoclax before.
  • Cannot be taking other experimental drugs.
  • Cannot have allergies to similar drugs.
  • Cannot have uncontrolled illnesses that make participation unsafe.
  • Pregnant or breastfeeding women cannot participate due to potential risks to the baby.
  • Cannot have conditions that affect the absorption of the drug.
  • Cannot receive live vaccines within 4 weeks before, during, or 30 days after treatment.

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