Trial · NCT06965114
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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. |
| Other | Changes in T and natural killer cell function (Phase 1) | Prior to and after tovorafenib and after tovorafenib plus rituximab, assessed up to 10 years | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT06965114/registered