Trial · NCT06965114
Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia
NCT06965114, Phase 1, Phase 2, Recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia. Trials, record NCT06965114. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06965114
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia
- NCT number
- NCT06965114
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 84 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Hairy Cell Leukemia, Recurrent Hairy Cell Leukemia, Refractory Hairy Cell Leukemia
- Interventions
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Cladribine, Computed Tomography, Rituximab, Tovorafenib
- First posted
- 2025-05-11
- Last updated
- 2026-07-31
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events (Phase 1) | During cycles 1-3 (cycle length = 28 days) | 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 frequency tables will be reviewed to determine toxicity patterns. |
| Primary | Minimal residual disease negative complete remission (MRD [-] CR) rate (Phase 2) | At completion of tovorafenib plus rituximab treatment versus cladribine plus rituximab | Will be calculated as the proportion of patients who achieve MRD (-) CR to therapy divided by the total number of patients for each treatment arm. All randomized patients or evaluable patients will be included in calculating the rate of MRD (-) CR for the study along with corresponding 95% binomial confidence intervals (CIs) (assuming that the number of patients who respond is binomially distributed). The MRD (-) CR rate will be compared between the untreated classical hairy cell leukemia (cHCL) patients with tovorafenib plus rituximab treatment and the patients with cladribine plus rituximab using the chi-square test or Fisher's exact test. |
| Secondary | MRD (-) CR rate (Phase 1) | At completion of tovorafenib plus rituximab | Will be calculated along with corresponding 95% binomial CIs (assuming that the number of patients who respond is binomially distributed). |
| Secondary | Overall response rate (ORR) (Phase 1) | At completion of tovorafenib plus rituximab | Will be calculated along with corresponding 95% binomial CIs (assuming that the number of patients who respond is binomially distributed). For the phase 2 portion, the ORR will be compared between the untreated cHCL patients with tovorafenib plus rituximab treatment and the patients with cladribine plus rituximab using the chi-square test or Fisher's exact test. |
| Secondary | Progression-free survival (Phase 1) | From initiation of therapy to documented progression or death without progression, assessed up to 10 years | Will initially be modeled using Kaplan-Meier methods, resulting in median survival times with 95% CI, assuming sufficient events have occurred. |
| Secondary | Overall survival (Phase 1) | From initiation of therapy to death from any cause, assessed up to 10 years | Will initially be modeled using Kaplan-Meier methods, resulting in median survival times with 95% CI, assuming sufficient events have occurred. |
| Secondary | Incidence of AEs (Phase 2) | From first dose of study treatment up to 30 days after the last dose of study medication, or until the start of subsequent antineoplastic therapy, whichever occurs first | Will be documented and summarized by type, grade, severity, and attribution using the CTCAE v 5.0 criteria for non-hematologic toxicities and the table on Criteria for Hematologic Toxicities. Will review all AE data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The incidence of severe (grade 3+) AEs or toxicities will be described. The number of treatment cycles received and reasons for going off treatment will be summarized to assess treatment tolerability. Will assess tolerability of the regimens through assessing the number of patients who required dose modifications and/or dose delays. Tolerability measures will be assessed within each treatment arm, and will explore differences in these measures between the arms. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. |
| Secondary | Rate of durable complete remission (CR) (Phase 2) | Up to 12 months after completing treatment | Will be defined as achieving a CR and not experiencing relapse at 12 months after completing treatment. |
| Secondary | Mutations or changes in transcription profile (Phase 1) | At baseline and at time of relapse, assessed up to 10 years | Will be assessed using whole exome and ribonucleic acid sequencing. |
| Other | Mitogen-activated protein kinase activation status (Phase 1) | During cycle 1 (cycle length = 28 days) | Graphical analyses will be largely used to assess potential patterns and relationships. All continuous measurements will be summarized using mean with standard deviations or median with range at each time point. Changes in these measurements from baseline to after treatment or baseline to progression will be assessed using paired t-tests or corresponding bob-parametric tests. The changes will also be compared between the treatment groups using two sample t-tests or Wilcoxon tests. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA186712 | The Ohio State University as a Lead Academic Organization (LAO) for the Experimental Therapeutics Clinical Trials Network | CARSON, WILLIAM E.; ARNOLD, SUSANNE M; EPPERLA, NARENDRANATH | OHIO STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06965114
GET https://conductscience.org/api/trials/v1/NCT06965114/registered