Study on Combining Tovorafenib and Rituximab for Treating Hairy Cell Leukemia

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT06965114

Provider View

This clinical trial is testing a new combination of drugs, tovorafenib and rituximab, to see if they are safe and effective in treating patients with classical hairy cell leukemia (cHCL) that has returned or not responded to previous treatments. The study also compares this new combination to the current standard treatment for patients who have not yet received any treatment.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new drug combination, tovorafenib and rituximab, in treating classical hairy cell leukemia (cHCL) that has either come back after treatment or has not responded to previous treatments. Tovorafenib works by blocking certain proteins that help cancer cells grow, while rituximab helps the immune system target and kill cancer cells. The study will also compare this new combination to the standard treatment of cladribine and rituximab in patients who have not yet been treated for cHCL.

Description

The study is divided into two phases:

Phase 1:

  • Patients will take tovorafenib by mouth once a week for up to 16 weeks.
  • Rituximab will be given through an IV on specific weeks.
  • Patients will have regular blood tests, CT scans, and bone marrow tests.

Phase 2:

  • Patients will be randomly assigned to one of two groups:
    • Group A: Will receive cladribine and rituximab through an IV over several cycles.
    • Group B: Will receive tovorafenib by mouth and rituximab through an IV over several cycles.
  • Both groups will have regular blood tests, CT scans, and bone marrow tests.

After completing the treatment, patients will have follow-up visits every six months to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of classical hairy cell leukemia (cHCL) with a specific BRAF mutation.
  • Phase 1: Must have had at least one previous treatment unless not possible. Previous treatment with vemurafenib is allowed.
  • Phase 2: Must not have had any previous treatment for cHCL.
  • Must be 18 years or older.
  • Must meet certain health criteria, such as specific blood counts and organ function.
  • Must not have any active infections like HIV or hepatitis unless under control.
  • Must agree to use effective birth control during the study and for 12 months after.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot have central nervous system involvement with cHCL.
  • Cannot have a different type of hairy cell leukemia or lack the specific BRAF mutation.
  • Cannot have very low platelet counts.
  • Cannot be on certain blood thinners or other medications that interfere with the study.
  • Cannot have unresolved side effects from previous cancer treatments.
  • Cannot be pregnant or breastfeeding.
  • Cannot have allergies to the study drugs.
  • Cannot have difficulty swallowing pills or have certain digestive issues.
  • Cannot have received live vaccines recently.
  • Cannot have other serious health conditions that would make participation unsafe.

Locations

FACILITYZIPCITYSTATE
Ohio State University Comprehensive Cancer Center LAO43210ColumbusOhio

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