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NCT05388123 · ClinicalTrials.gov registry record · Phase 2
Low Dose Vemurafenib and Rituximab in Hairy Cell Leukemia
A Phase 2 study of Hairy Cell Leukemia, sponsored by Scripps Health.
- Active
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05388123: Active Phase 2 study of Hairy Cell Leukemia, sponsored by Scripps Health.
NCT05388123 is a Phase 2 study of Hairy Cell Leukemia that is active but no longer recruiting, run by Scripps Health. The registered enrollment target is 20 participants, below the 71-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05388123, a Phase 2 study of Hairy Cell Leukemia, is active but no longer recruiting, sponsored by Scripps Health.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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 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.
Primary Outcome
Resolution of cytopenias and splenomegaly
Conditions Studied
Interventions
- DRUG Low dose vemurafenib plus rituximab
Study Locations (1)
California
- Scripps Cancer Center - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-03-02 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 2 |
What the registry record for NCT05388123 still lists
NCT05388123 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 71-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Hairy Cell Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Low dose vemurafenib plus rituximab is the first listed.
NCT05388123 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05388123 about?
NCT05388123 is a clinical study titled "Low Dose Vemurafenib and Rituximab in Hairy Cell Leukemia". 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 treatm...
What is the current status of trial NCT05388123?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2022-03-02. Estimated completion is 2026-12-01.
What conditions does trial NCT05388123 study?
This clinical trial studies the following conditions: Hairy Cell Leukemia.
What interventions are being tested in trial NCT05388123?
The interventions under investigation include: Low dose vemurafenib plus rituximab (DRUG).
Who is sponsoring clinical trial NCT05388123?
This trial is sponsored by Scripps Health, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05388123 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hairy Cell Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05388123's enrollment target sits among peer trials
20 15th of 15 higher than 1 of 15 other Hairy Cell Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hairy Cell Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL)
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-
Binimetinib for People With Relapsed/Refractory BRAF Wild Type Hairy Cell Leukemia and Variant
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-
Encorafenib Plus Binimetinib for People With BRAF V600 Mutated Relapsed/Refractory HCL
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Cladribine With Simultaneous or Delayed Rituximab to Treat Hairy Cell Leukemia
ACTIVE NOT RECRUITING · Phase 2
-
A Phase II Study of the BRAF Inhibitor, Vemurafenib, Plus Obinutuzumab in Patients With Previously Untreated Classical Hairy Cell Leukemia
ACTIVE NOT RECRUITING · Phase 2
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