New combo aims to tame hairy cell leukemia with fewer side effects
NCT ID NCT05388123
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a combination of two drugs—vemurafenib (taken by mouth) and rituximab (given by IV)—in 15 people with hairy cell leukemia, a rare blood cancer. The goal was to see if this treatment works as well as or better than standard chemotherapy, but with fewer side effects. Participants received a lower dose of vemurafenib than in past studies to try to reduce skin reactions and other problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vemurafenib and rituximab
- What this could lead to
- If successful, this could offer a less toxic, effective treatment option for hairy cell leukemia, reducing side effects compared to standard chemotherapy.
- What could go wrong
- This is a small, early-phase pilot study with only 15 participants, so results may not apply broadly. The low-dose vemurafenib might be less effective, and side effects are still possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
15 people
The number who actually took part.
- Started
-
Mar 2022
- Finished
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Apr 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 90 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * ≥ 18 years of age * Histologically confirmed HCL that are BRAF V600E positive by IHC or NGS * Patient's must meet the standard treatment initiation criteria, as defined by ANC ≤1.0, Hgb ≤ 10.0 or PLT ≤100K * Patients can either have (1) not received any prior therapy for the disease or have had (2) failure to achieve any response to the initial purine analog-based therapy or (3) subsequent relapse after any prior therapy. * ECOG performance status of 0-2 * 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 * For women of childbearing potential, agreement to use acceptable methods of contraception * For men with female partners of childbearing potential, agreement to use barrier contraception * Negative serum pregnancy test within 7 days of commencement of treatment in premenopausal women. * Ability to understand and willingness to sign a written informed consent document. * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: * Pregnant or breast-feeding or intending to become pregnant during the study * Have had chemotherapy (including purine analogs), rituximab, and other investigational agents within six weeks prior to entering the study. The patients cannot have received BRAF inhibitor therapy within 6 months of entering the study. * Major surgery within 4 weeks prior to entering the study * Invasive malignancy within the past 2 years prior to first study drug administration, except for adequately treated (with curative intent) basal or squamous cell carcinoma, melanoma, in situ carcinoma of the cervix, in situ ductal adenocarcinoma of the breast, in situ prostate cancer, or limited stage bladder cancer or other cancers from which the patient has been disease-free for at least 2 years * Active HIV, hepatitis B and hepatitis C or any clinically significant history of liver disease. Hepatitis B prior infection is not a contraindication though will require therapy. * Known hypersensitivity to any of the study drugs * Patients with HCL that are BRAF V600E mutation negative
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Scripps Cancer Center
La Jolla, California, 92037, United States
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