Low dose vemurafenib plus rituximab for Leukemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Scripps MD Anderson Cancer Center, La Jolla, CA
Leukemia+2 More
Low dose vemurafenib plus rituximab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The current standard-of-care for Hairy Cell Leukemia involves chemotherapy, with agents such as cladribine or pentostatin. Chemotherapy is associated with infection, low blood counts and predisposition to future cancers. This study tests a new drug combination for the treatment of hairy cell leukemia. The treatment involves 8 weeks of treatment with an oral drug called vemurafenib and 8 doses of an intravenous medication called rituximab. The goal of this study is to see whether this treatment is better tolerated and more effective than the currently used treatment in this disease. In addition, this study uses a lower dose of vemurafenib than previous studies have used, with the goal of minimizing side effects from this medication.

Eligible Conditions

  • Leukemia
  • Hairy Cell Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 2 years from enrollment

Year 2
MRD Status
Year 2
Relapse-Free Survival
Year 2
Complete Response
Time to hematologic response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Low dose Vemurafenib and Rituximab
1 of 1
Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Low dose vemurafenib plus rituximab · No Placebo Group · Phase 2

Low dose Vemurafenib and Rituximab
Drug
Experimental Group · 1 Intervention: Low dose vemurafenib plus rituximab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years from enrollment
Closest Location: Scripps MD Anderson Cancer Center · La Jolla, CA
Photo of La Jolla 1Photo of La Jolla 2Photo of La Jolla 3
2022First Recorded Clinical Trial
1 TrialsResearching Leukemia
1 CompletedClinical Trials

Who is running the clinical trial?

Scripps HealthLead Sponsor
50 Previous Clinical Trials
12,617 Total Patients Enrolled
3 Trials studying Leukemia
100 Patients Enrolled for Leukemia

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
A negative pregnancy test within 7 days of commencement of treatment in premenopausal women.
You are able to understand and are willing to sign a written informed consent document.
You have histologically confirmed Hodgkin lymphoma that is BRAF V600E positive by IHC or NGS.
You are of childbearing potential.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.