---
title: "Low-dose vemurafenib plus rituximab (Scripps regimen) for frontline and relapsed hairy cell leukem"
id: "pubmed-42308249"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42308249"
content_type: "clinical_feed_article"
specialty: "Oncology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42308249/"
doi: "10.1182/bloodadvances.2025019243"
published_at: "2026-08-25T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Low-dose vemurafenib plus rituximab (Scripps regimen) for frontline and relapsed hairy cell leukem
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42308249
- **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42308249/)
- **DOI:** [10.1182/bloodadvances.2025019243](https://doi.org/10.1182%2Fbloodadvances.2025019243)
- **Published At:** 2026-08-25T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- This prospective observational study evaluated a low-dose combination of the **BRAF inhibitor vemurafenib** (240 mg twice daily for 8 weeks) with **rituximab** (375 mg/m2 IV every 2 weeks for 14 weeks, 8 doses) in adults with treatment-naïve or relapsed/refractory hairy cell leukemia (HCL). - Fifteen patients were enrolled and all achieved complete hematologic recovery: platelet count >100 × 10^3/μL at a median of 15 days and neutrophil count >1.0 × 10^3/μL at a median of 29 days. - Overall response rate was 87%; 11 patients (73%; 95% CI, 48–89) achieved complete response (CR) and 2 achieved partial response. - Minimal residual disease (MRD) negativity at 6 months was observed in 8 patients (53%; 95% CI, 27–79). - Among frontline patients (n = 7), there were 6 CRs (86%) and 4 MRD-negative cases (57%); among relapsed/refractory patients (n = 8; median 1 prior therapy), there were 5 CRs (63%) and 4 MRD-negative cases (50%). - At a median follow-up of 18 months, median progression-free survival (PFS) was not reached; one patient progressed at 20 months. - The regimen demonstrated favorable tolerability with no grade 3–4 toxicities or deaths reported in the cohort. - The study authors conclude that low-dose vemurafenib plus rituximab induced rapid hematologic recovery and was well tolerated in both untreated and relapsed/refractory HCL. - Trial registration: ClinicalTrials.gov NCT05388123. These points are drawn directly from the study abstract and figures; further protocol or subgroup details beyond the abstract were not reported in the source.
## Clinical Analysis & Structured Key Points
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Affiliations Expand ### Affiliation * 1 Division of Hematology and Oncology, Scripps Clinic Medical Group, La Jolla, CA. * PMID: **42308249** * PMCID: [ PMC13495371 ](https://pmc.ncbi.nlm.nih.gov/articles/PMC13495371/) * DOI: [ 10.1182/bloodadvances.2025019243 ](https://doi.org/10.1182/bloodadvances.2025019243) Item in Clipboard Observational Study # Low-dose vemurafenib plus rituximab in frontline and relapsed or refractory hairy cell leukemia: the Scripps regimen David Jacob Hermel et al. Blood Adv. 2026. Show details Display options Display options Format Abstract PubMed PMID Blood Adv Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Blood+Adv%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Blood+Adv%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42308249/) . 2026 Aug 25;10(16):5635-5642. doi: 10.1182/bloodadvances.2025019243. ### Authors [David Jacob Hermel](https://pubmed.ncbi.nlm.nih.gov/?term=Hermel+DJ&cauthor_id=42308249)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42308249/#short-view-affiliation-1 "Division of Hematology and Oncology, Scripps Clinic Medical Group, La Jolla, CA."), [Alan Saven](https://pubmed.ncbi.nlm.nih.gov/?term=Saven+A&cauthor_id=42308249)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42308249/#short-view-affiliation-1 "Division of Hematology and Oncology, Scripps Clinic Medical Group, La Jolla, CA.") ### Affiliation * 1 Division of Hematology and Oncology, Scripps Clinic Medical Group, La Jolla, CA. * PMID: **42308249** * PMCID: [ PMC13495371 ](https://pmc.ncbi.nlm.nih.gov/articles/PMC13495371/) * DOI: [ 10.1182/bloodadvances.2025019243 ](https://doi.org/10.1182/bloodadvances.2025019243) Item in Clipboard Full text links Cite Display options Display options Format Abstract PubMed PMID ## Abstract Purine nucleoside analogs are highly effective in the treatment of hairy cell leukemia (HCL) but are associated with myelosuppression and immunosuppression. Targeted therapy with the BRAF inhibitor vemurafenib in combination with the anti-CD20 antibody rituximab has shown marked efficacy, but traditional dosing of vemurafenib (960 mg twice daily) requires frequent dose reductions. We conducted a prospective observational study of low-dose vemurafenib (240 mg twice daily orally for 8 weeks) plus rituximab (375 mg/m2 IV every 2 weeks for 14 weeks, 8 total doses) in adults with treatment-naïve or relapsed/refractory HCL. Fifteen patients were enrolled. All achieved complete hematologic recovery, with normalization of thrombocytopenia (platelet count >100 × 103/μL) and neutropenia (neutrophil count >1.0 × 103/μL) at a median of 15 and 29 days, respectively. The overall response rate was 87%, including 11 complete responses (CRs; 73%; 95% confidence interval [CI], 48-89) and 2 partial responses, with 8 patients (53%; 95% CI, 27-79) achieving minimal residual disease (MRD) negativity at 6 months. Frontline patients (n = 7) had 6 CRs (86%; 95% CI, 42-100) and 4 were MRD-negative (57%; 95% CI, 18-90), whereas relapsed/refractory patients (n = 8; median of 1 prior therapy) had 5 CRs (63%; 95% CI, 24-91) and 4 were MRD-negative (50%; 95% CI, 16-84). At a median follow-up of 18 months, 1 patient progressed at 20 months; median progression-free survival was not reached. No grade 3 to 4 toxicities or deaths occurred. Low-dose vemurafenib combined with rituximab induced rapid hematologic recovery and favorable tolerability in patients with both untreated and relapsed/refractory HCL. This trial was registered at www.clinicaltrials.gov as [NCT05388123](http://clinicaltrials.gov/show/NCT05388123 "See in ClinicalTrials.gov"). © 2026 American Society of Hematology. Published by Elsevier Inc. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement Conflict-of-interest disclosure: The authors declare no competing financial interests. ## Figures [ ![None](https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee59/13495371/fc69a619b1e0/BLOODA_ADV-2025-019243-ga1.gif) ](https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee59/13495371/8aa47550c553/BLOODA_ADV-2025-019243-ga1.webp) ** Graphical abstract ** ** Graphical abstract ** **Graphical abstract** [ ![Figure 1.](https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee59/13495371/ff8b0bd66b6d/BLOODA_ADV-2025-019243-gr1.gif) ](https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee59/13495371/ed024c9a8246/BLOODA_ADV-2025-019243-gr1.webp) ** Figure 1. ** **Treatment schema of low-dose vemurafenib…** ** Figure 1. ** **Treatment schema of low-dose vemurafenib plus rituximab.** Vemurafenib (240 mg twice daily) was… **Figure 1.** **Treatment schema of low-dose vemurafenib plus rituximab.** Vemurafenib (240 mg twice daily) was administered continuously for 8 weeks (red bar). Rituximab (375 mg/m2 IV) was given every 2 weeks for 8 total doses (blue circles), starting concurrently with vemurafenib and continuing for 3 additional doses after its completion (total duration, 14 weeks). BID, twice daily. [ ![Figure 2.](https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee59/13495371/95318208af64/BLOODA_ADV-2025-019243-gr2.gif) ](https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee59/13495371/d2481126d18e/BLOODA_ADV-2025-019243-gr2.webp) ** Figure 2. ** **Time course of key hematologic…** ** Figure 2. ** **Time course of key hematologic parameters following treatment.** (A) WBC count initially fluctuates… **Figure 2.** **Time course of key hematologic parameters following treatment.** (A) WBC count initially fluctuates but demonstrates a gradual overall increase. (B) ANC shows a steady increase over 84 days. (C) Platelet count sharply increases by day 28, then stabilizes with mild fluctuations. (D) Hgb remains stable early but rises after day 28. The error bars represent SEM across measurements. Hgb, hemoglobin; SEM, standard error of the mean; WBC, white blood cell. [ ![Figure 3.](https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee59/13495371/b31d550dfd3d/BLOODA_ADV-2025-019243-gr3.gif) ](https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee59/13495371/a905f706e448/BLOODA_ADV-2025-019243-gr3.webp) ** Figure 3. ** **Baseline vs posttreatment marrow cellularity…** ** Figure 3. ** **Baseline vs posttreatment marrow cellularity with MRD status.** Bar graphs depict HCL marrow… **Figure 3.** **Baseline vs posttreatment marrow cellularity with MRD status.** Bar graphs depict HCL marrow cellularity (percentage) for 15 patients at baseline (sky blue bars) and after treatment (green bars). Posttreatment MRD negativity is indicated by black “X” markers above the bars. The graph illustrates the reduction in marrow cellularity following treatment and highlights patients achieving MRD negativity. Notably, patients 4, 5, and 6 had no IHC evidence of HCL yet had small flow populations of HCL (marked by a red dot). HCL marrow cellularity was assessed by IHC. [See this image and copyright information in PMC](https://pubmed.ncbi.nlm.nih.gov/42308249/) ## Similar articles * [ Single agent vemurafenib or rituximab-vemurafenib combination for the treatment of relapsed/refractory hairy cell leukemia, a multicenter experience. ](https://pubmed.ncbi.nlm.nih.gov/38599153/) Yiğit Kaya S, Mutlu YG, Malkan ÜY, Mehtap Ö, Keklik Karadağ F, Korkmaz G, Elverdi T, Saydam G, Özet G, Ar MC, Melek E, Maral S, Kaynar L, Sevindik ÖG.Yiğit Kaya S, et al.Leuk Res. 2024 May;140:107495. doi: 10.1016/j.leukres.2024.107495. Epub 2024 Mar 29.Leuk Res. 2024.PMID: 38599153 * [ Rituximab: a review of its use in non-Hodgkin's lymphoma and chronic lymphocytic leukaemia. ](https://pubmed.ncbi.nlm.nih.gov/12662126/) Plosker GL, Figgitt DP.Plosker GL, et al.Drugs. 2003;63(8):803-43. doi: 10.2165/00003495-200363080-00005.Drugs. 2003.PMID: 12662126Review. * [ Venetoclax plus rituximab in relapsed or refractory chronic lymphocytic leukaemia: a phase 1b study. ](https://pubmed.ncbi.nlm.nih.gov/28089635/) Seymour JF, Ma S, Brander DM, Choi MY, Barrientos J, Davids MS, Anderson MA, Beaven AW, Rosen ST, Tam CS, Prine B, Agarwal SK, Munasinghe W, Zhu M, Lash LL, Desai M, Cerri E, Verdugo M, Kim SY, Humerickhouse RA, Gordon GB, Kipps TJ, Roberts AW.Seymour JF, et al.Lancet Oncol. 2017 Feb;18(2):230-240. doi: 10.1016/S1470-2045(17)30012-8. Epub 2017 Jan 13.Lancet Oncol. 2017.PMID: 28089635Free PMC article.Clinical Trial. * [ Phase 2 trial of rituximab with either pentostatin or bendamustine for multiply relapsed or refractory hairy cell leukemia. ](https://pubmed.ncbi.nlm.nih.gov/41060318/) Schroeder B, Yuan C, Wang HW, Mohindroo C, Zhou H, Raffeld M, Xi L, Arons E, Feurtado J, James-Echenique L, Calvo KR, Maric I, Kreitman RJ.Schroeder B, et al.Blood. 2026 Feb 12;147(7):725-738. doi: 10.1182/blood.2025031243.Blood. 2026.PMID: 41060318Clinical Trial. * [ Treatment of hairy cell leukemia. ](https://pubmed.ncbi.nlm.nih.gov/32893700/) Chihara D, Kreitman RJ.Chihara D, et al.Expert Rev Hematol. 2020 Oct;13(10):1107-1117. doi: 10.1080/17474086.2020.1819231. Epub 2020 Sep 24.Expert Rev Hematol. 2020.PMID: 32893700Review. [ See all similar articles ](https://pubmed.ncbi.nlm.nih.gov/?linkname=pubmed_pubmed&from_uid=42308249) ## References 1. 1. Saven A, Goodman GR. Hairy cell leukemia: 2020 update on diagnosis, risk-stratification, and treatment. Blood. 2020;135:341–352. 2. 1. Saven A, Burian C, Koziol JA, Piro LD. Long-term follow-up of patients with hairy cell leukemia after cladribine treatment. Blood. 1998;92(6):1918–1926. - [PubMed](https://pubmed.ncbi.nlm.nih.gov/9731048/) 3. 1. Piro LD, Carrera CJ, Carson DA, Beutler E. Lasting remissions in hairy-cell leukemia induced by a single infusion of 2-chlorodeoxyadenosine. N Engl J Med. 1990;322(16):1117–1121. - [PubMed](https://pubmed.ncbi.nlm.nih.gov/1969613/) 4. 1. Goodman GR, Burian C, Koziol JA, Saven A. Extended follow-up of patients with hairy cell leukemia after treatment with cladribine. J Clin Oncol. 2003;21(5):891–896. - [PubMed](https://pubmed.ncbi.nlm.nih.gov/12610190/) 5. 1. Tiacci E, Park JH, De Carolis L, et al. Targeting mutant BRAF in relapsed or refractory hairy-cell leukemia. N Engl J Med. 2015;373(18):1733–1747. - [PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC4811324/) - [PubMed](https://pubmed.ncbi.nlm.nih.gov/26352686/) Show all 19 references ## Publication types * Observational Study Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Observational+Study%22%5Bpt%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Observational+Study) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42308249/) ## MeSH terms * Adult Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Adult%22%5BMeSH%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Adult) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42308249/) * Aged Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Aged%22%5BMeSH%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Aged) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42308249/) * Antineoplastic Combined Chemotherapy Protocols* / adverse effects Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Antineoplastic+Combined+Chemotherapy+Protocols%2Fadverse+effects%22%5BMAJR%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Antineoplastic+Combined+Chemotherapy+Protocols) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42308249/) * Antineoplastic Combined Chemotherapy Protocols* / therapeutic use Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Antineoplastic+Combined+Chemotherapy+Protocols%2Ftherapeutic+use%22%5BMAJR%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Antineoplastic+Combined+Chemotherapy+Protocols) * [ Add
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