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NCT06965114 · ClinicalTrials.gov registry record · Phase 1
Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia
A Phase 1 study of Hairy Cell Leukemia and Recurrent Hairy Cell Leukemia, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
- 1
- Study location
NCT06965114 is a Phase 1 study of Hairy Cell Leukemia and Recurrent Hairy Cell Leukemia that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 84 participants, above the 67-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target (25% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06965114, a Phase 1 study of Hairy Cell Leukemia and Recurrent Hairy Cell Leukemia, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial tests the safety, side effects, and effectiveness of tovorafenib in combination with rituximab in patients with classical hairy cell leukemia (cHCL) that has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory) and compares the effect of tovorafenib and rituximab to current standard treatment of cladribine and rituximab in cHCL patients that have not yet received treatment. Tovorafenib blocks certain proteins made by the mutated BRAF gene, which may help keep cancer cells from growing. It is a type of kinase inhibitor. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cladribine damages the cell's deoxyribonucleic acid and may kill cancer cells. It is a type of antimetabolite. Giving tovorafenib in combination with rituximab may be safe and tolerable and more effective than cladribine with rituximab in treating patients with untreated, recurrent or refractory cHCL.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
- DRUG Cladribine
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2026-06-27 |
| Est. Completion | 2030-03-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06965114
The ClinicalTrials.gov registry entry for NCT06965114 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 67-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target (25% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Hairy Cell Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06965114 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT06965114 about?
NCT06965114 is a clinical study titled "Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia". This phase I/II trial tests the safety, side effects, and effectiveness of tovorafenib in combination with rituximab in patients with classical hairy cell leukemia (cHCL) that has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory) and com...
What is the current status of trial NCT06965114?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2026-06-27. Estimated completion is 2030-03-01.
What conditions does trial NCT06965114 study?
This clinical trial studies the following conditions: Hairy Cell Leukemia, Recurrent Hairy Cell Leukemia, Refractory Hairy Cell Leukemia.
What interventions are being tested in trial NCT06965114?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Cladribine (DRUG).
Who is sponsoring clinical trial NCT06965114?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06965114 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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