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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: Recruiting Phase 1 study of Hairy Cell Leukemia and Recurrent Hairy Cell Leukemia, sponsored by National Cancer Institute (NCI).

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Adverse events (AEs) will be documented and summarized by type, grade, severity, and attribution using the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 criteria for non-hematologic toxicities and table of criteria for hematologic toxicities. In addition, the number of treatment cycles received and reasons for going off treatment will be summarized to assess treatment tolerability. The maximum grade for each type of toxicity will be recorded for each patient, and frequen

Conditions Studied

Hairy Cell Leukemia Recurrent Hairy Cell Leukemia Refractory Hairy Cell Leukemia

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

FieldValue
Enrollment Target 84 participants
Start Date 2026-06-27
Est. Completion 2030-03-01
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What NCT06965114 shows while recruiting

NCT06965114 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, above the 67-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target (25% higher).

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 a single indexed study location in 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.

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 NCT06965114's enrollment target sits among peer trials

84 5th of 15 higher than 11 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

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More recruiting context for NCT06965114

Source: ClinicalTrials.gov NCT06965114, the US trial registry maintained by the National Library of Medicine. NCT06965114 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.