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Monoclonal Antibodies

Vemurafenib + Rituximab for Hairy Cell Leukemia

Phase 2
Recruiting
Led By Alan Saven, MD
Research Sponsored by Scripps Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Acceptable pre-study organ function during screening not exacerbated by Hairy Cell Leukemia. General thresholds should be a total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN, and serum creatinine ≤ 1.5x ULN
Histologically confirmed HCL that are BRAF V600E positive by IHC or NGS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from enrollment
Awards & highlights

Study Summary

This trial is testing a new, oral drug combination for the treatment of hairy cell leukemia that is hoped to be more effective and have fewer side effects than the current standard-of-care chemotherapy.

Who is the study for?
This trial is for adults with Hairy Cell Leukemia that's BRAF V600E positive. They should have normal organ function, not be pregnant or breastfeeding, and agree to use contraception. It's open to those who haven't had treatment before, didn't respond to initial therapy, or relapsed after any treatment.Check my eligibility
What is being tested?
The study tests a combination of low dose vemurafenib (oral) and rituximab (IV) over 8 weeks. This approach aims to see if it's more effective and better tolerated than standard chemotherapy treatments for this type of leukemia.See study design
What are the potential side effects?
Potential side effects may include infection risks due to lowered blood counts from the medications used in the trial. Specific side effects related to vemurafenib can include joint pain, rash, fatigue, hair loss and others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver and kidney functions are within acceptable ranges.
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My HCL cancer is confirmed to be BRAF V600E positive.
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I can take care of myself and am up and about more than half of the day.
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I am 18 years old or older.
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My blood counts are low enough to start standard treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response
Secondary outcome measures
MRD Status
Relapse-Free Survival
Time to hematologic response

Trial Design

1Treatment groups
Experimental Treatment
Group I: Low dose Vemurafenib and RituximabExperimental Treatment1 Intervention
Eligible patients will receive vemurafenib at a dose of 240 mg orally twice daily (b.i.d.) continuously for 8 weeks. Rituximab 375 mg/m2 will be administered every 2 weeks for a total of 16 weeks. The entire duration of treatment will be 16 weeks.

Find a Location

Who is running the clinical trial?

Scripps HealthLead Sponsor
55 Previous Clinical Trials
43,441 Total Patients Enrolled
Alan Saven, MDPrincipal InvestigatorScripps Clinic

Media Library

Rituximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05388123 — Phase 2
Hairy Cell Leukemia Research Study Groups: Low dose Vemurafenib and Rituximab
Hairy Cell Leukemia Clinical Trial 2023: Rituximab Highlights & Side Effects. Trial Name: NCT05388123 — Phase 2
Rituximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05388123 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible for me to participate in this investigation?

"This scientific experiment is searching for twenty people with leukemia aged 18 to 90. To become eligible, individuals must pass a serum pregnancy test conducted within the week prior to receiving treatment (only applicable for women premenopausal). Additionally, participants have to sign an informed consent document and meet certain medical criteria such as having ECOG performance status of 0-2 ,acceptable organ function during screening not exacerbated by HCL and bilirubin ≤ 1.5 times upper limit of normal etc. Lastly, male patients with female partners are expected to use barrier contraception while all women of childbearing potential need acceptably effective contraceptive methods throughout the study's duration."

Answered by AI

Are any new participants being admitted for this trial currently?

"According to clinicaltrials.gov, this medical experiment is currently searching for eligible patients with the trial having been posted on January 1st 2022 and most recently updated on May 19th of that same year."

Answered by AI

Has the combination of low dose vemurafenib and rituximab been sanctioned by the U.S Food & Drug Administration?

"Our team at Power has rated the safety of Low dose vemurafenib plus rituximab as a 2. This is due to Phase 2 trial results, providing limited data regarding its efficacy and some information concerning its security."

Answered by AI

How many participants are currently partaking in this clinical research?

"Affirmative. It is evident from the information hosted on clinicaltrials.gov that this medical trial first appeared online in January of 2022 and was last updated in May, with an aim to recruit 20 patients at a single site."

Answered by AI

Is the age cutoff for participation in this clinical trial under 55 years old?

"To be eligible for this medical trial, patients must have attained the age of majority and not yet reached their ninetieth birthday. There are 427 trials available to those below 18 years old and 1,127 studies accessible to individuals over 65."

Answered by AI
~4 spots leftby Jan 2025