Study on Low Dose Vemurafenib and Rituximab for Treating Hairy Cell Leukemia

Sponsor: Scripps Health

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05388123

Provider View

This clinical trial is testing a new treatment combination of vemurafenib and rituximab for patients with Hairy Cell Leukemia. The study aims to find out if this treatment is more effective and has fewer side effects than the current standard chemotherapy.

Patient Parameters

Program Overview

The study is exploring a new treatment for Hairy Cell Leukemia using a combination of two drugs: vemurafenib, taken orally, and rituximab, given through an IV. The goal is to see if this combination is better tolerated and more effective than traditional chemotherapy, which can cause infections and low blood counts. The study uses a lower dose of vemurafenib to reduce side effects.

Description

This trial is being conducted at a single center and involves patients with Hairy Cell Leukemia who have either not been treated before or have not responded well to previous treatments. Participants will take vemurafenib pills twice a day for 8 weeks. At the same time, they will receive rituximab through an IV every two weeks. After finishing vemurafenib, they will continue with rituximab every two weeks for a total of 8 weeks. The entire treatment lasts 16 weeks. Six months after starting the treatment, doctors will perform a bone marrow test to see how well the treatment worked and check for any remaining cancer cells.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of Hairy Cell Leukemia with a specific BRAF V600E mutation.
  • Meet certain blood count criteria indicating the need for treatment.
  • Either have not received any prior treatment, did not respond to initial treatment, or have relapsed after previous treatment.
  • Be in good general health with an ECOG performance status of 0 to 2.
  • Have acceptable organ function based on specific blood tests.
  • Women of childbearing potential must agree to use contraception.
  • Men with female partners of childbearing potential must agree to use barrier contraception.
  • Women must have a negative pregnancy test before starting treatment.
  • Be able to understand and sign a consent form.
  • Be willing to follow the study schedule and procedures.

Exclusion Criteria

  • Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have received chemotherapy, rituximab, or other investigational drugs within six weeks before the study.
  • Have had BRAF inhibitor therapy within six months before the study.
  • Have had major surgery within four weeks before the study.
  • Have had another invasive cancer within the past two years, except for certain treated skin cancers or other cancers that have been in remission for at least two years.
  • Have active HIV, hepatitis B, or hepatitis C infections, or significant liver disease.
  • Have a known allergy to any of the study drugs.
  • Have Hairy Cell Leukemia without the BRAF V600E mutation.

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