Last reviewed · How we verify
NCT05388123
Low Dose Vemurafenib and Rituximab in Hairy Cell Leukemia
Phase 2 trial testing Low dose vemurafenib plus rituximab in Hairy Cell Leukemia in 20 participants. Participants enrolled and being followed up; not accepting new ones.
1 December 2026
Quick facts
| Lead sponsor | Scripps Health |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 2 March 2022 |
| Primary completion | 1 December 2026 |
| Estimated completion | 1 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Low dose vemurafenib plus rituximab — full drug profile →
Conditions studied
- Hairy Cell Leukemia — all drugs for Hairy Cell Leukemia →
Sponsor
Scripps Health — full company profile →
Who can join
Adults 18 to 90, any sex, with Hairy Cell Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 yet previously validated 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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The protective role of the microenvironment in hairy cell leukemia treatment: Facts and perspectives.
Gargiulo E, Giordano M, Niemann CU, Moussay E, et al · · 2023 · cited 2× · PMID 36968995 · DOI 10.3389/fonc.2023.1122699
Verify or expand the search:
- PubMed search for NCT05388123
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hairy Cell Leukemia
Currently open trials in the same condition.
- NCT06965114 — Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia · Phase 1, PHASE2 · recruiting
- NCT06561360 — A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL) · Phase 2 · recruiting
- NCT04815356 — Phase I Study of Anti-CD22 Chimeric Receptor T Cells in Patients With Relapsed/Refractory Hairy Cell Leukemia and Varian · Phase 1 · recruiting
- NCT04775745 — Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies. · Phase 1 · recruiting
- NCT04322383 — Binimetinib for People With Relapsed/Refractory BRAF Wild Type Hairy Cell Leukemia and Variant · Phase 2 · recruiting
Other Scripps Health trials
Trials by the same sponsor.
- NCT06590285 — Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation · NA · recruiting
- NCT07420400 — Non-Invasive Detection of Right-to-Left Cardiac Shunts · recruiting
- NCT06610097 — TNBC Gut Microbiota During Neoadjuvant Treatment · NA · recruiting
- NCT06631300 — A Randomized, Placebo-controlled Trial of Prednisone in Refractory Restless Legs Syndrome: a Pilot Study · Phase 1, PHASE2 · not yet recruiting
- NCT05611749 — Duloxetine Impact on Postoperative Pain Control and Outcomes · Phase 2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05388123 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Scripps Health
- Last refreshed: 29 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05388123.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing