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BCL-2 Inhibitor

Venetoclax for Relapsed Hairy Cell Leukemia

Phase 2

Recruiting

Led By Robert J Kreitman

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)

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

Must not have

Patients who have received prior venetoclax

Malabsorption syndrome or other conditions that would interfere with intestinal absorption

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after the last dose

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drug called venetoclax to see how well it works in treating patients with hairy cell leukemia that has come back after showing improvement. Venetoclax is a type of

Who is the study for?

This trial is for adults over 18 with relapsed hairy cell leukemia after prior treatment, who can't have BRAF therapy and haven't tried Venetoclax. They need functioning kidneys, acceptable liver tests, and a decent performance status. People with treated hepatitis C or controlled HIV are eligible; those with chronic hepatitis B must be on suppressive therapy.

What is being tested?

The study is testing Venetoclax's effectiveness in patients whose hairy cell leukemia has returned. It involves taking the drug and undergoing various assessments like blood tests, bone marrow procedures, CT scans, and MRIs to see how well it works against cancer cells.

What are the potential side effects?

Venetoclax may cause side effects such as nausea, diarrhea, fatigue, low blood counts leading to increased infection risk or bleeding problems. Liver function might also be affected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but may not be able to do heavy physical work.

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

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I am 18 years old or older.

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My kidney function is within the required range.

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I need treatment because my blood counts are low or my cancer is growing.

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My hepatitis B virus load is undetectable with treatment.

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I haven't been treated for HCL/HCLv in the last 4 weeks or my last treatment didn't work.

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I have HCL/HCLv, relapsed or can't have BRAF therapy, and haven't had venetoclax.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with venetoclax.

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I do not have conditions that affect how my body absorbs nutrients.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after the last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after the last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after the last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate

Secondary study objectives

Complete remission (CR) rate

MRD negativity

Minimal residual disease (MRD)-negative CR rate

Other study objectives

TP53 mutations and other mutations

Whole exome sequencing of relapsed HCL/HCLv samples

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (venetoclax)Experimental Treatment6 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Bone Marrow Biopsy

2021

Completed Phase 3

~230