Trial · NCT07468916
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response | Up to 24 months | Will be assessed per the 2015 international consortium proposal (ICP) myelodysplastic syndrome (MDS)/myeloproliferative neoplasm (MPN) criteria. Overall response rate is defined as the best objective 2015 ICP MDS/MPN response achieved at any time on study (complete remission, complete cytogenetic remission, partial remission, marrow response or clinical benefit). Will be summarized as proportions with corresponding 95% exact binomial confidence intervals. |
| Primary | Incidence of adverse events | Up to 24 months | The incidence of adverse events, both hematological and non-hematological will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will be summarized as proportions with corresponding 95% exact binomial confidence intervals. |
| Secondary | Cytogenetics | At baseline | Statistical analyses will primarily be descriptive. All other safety and efficacy endpoints will be summarized using appropriate descriptive statistics, including counts and proportions for categorical variables and means, medians, standard deviations, and ranges for continuous variables. |
| Secondary | Mutation profile | At baseline | Statistical analyses will primarily be descriptive. All other safety and efficacy endpoints will be summarized using appropriate descriptive statistics, including counts and proportions for categorical variables and means, medians, standard deviations, and ranges for continuous variables. |
| Secondary | Chronic myelomonocytic leukemia-specific prognostic scoring system - molecular risk | At baseline | Statistical analyses will primarily be descriptive. All other safety and efficacy endpoints will be summarized using appropriate descriptive statistics, including counts and proportions for categorical variables and means, medians, standard deviations, and ranges for continuous variables. |
| Secondary | Clinical benefit | Every 3 cycles (cycle length = 28 days) | Will be based on 2015 ICP MDS/MPN criteria. Statistical analyses will primarily be descriptive. All other safety and efficacy endpoints will be summarized using appropriate descriptive statistics, including counts and proportions for categorical variables and means, medians, standard deviations, and ranges for continuous variables. |
| Secondary | Progression-free survival | From initiation of treatment to disease progression or death, assessed up to 24 months | Progression will be evaluated per 2015 ICP MDS/MPN criteria. Will be analyzed using the Kaplan-Meier method, with median times and associated 95% confidence intervals estimated using the Brookmeyer-Crowley method. |
| Secondary | Overall survival | From initiation of treatment to death, assessed up to 24 months | Will be analyzed using the Kaplan-Meier method, with median times and associated 95% confidence intervals estimated using the Brookmeyer-Crowley method. |
| Secondary | Change in mutant allele frequencies | From baseline to every 3rd cycle (cycle length = 28 days) | Will evaluate the change from baseline mutant allele frequencies, with special interests in ASXL1, SRSF2, NRAS, KRAS, SETBP1, RUNX1, CBL, EZH2, SF3B1 mutations; as also in non-driver mutations. Statistical analyses will primarily be descriptive. All other safety and efficacy endpoints will be summarized using appropriate descriptive statistics, including counts and proportions for categorical variables and means, medians, standard deviations, and ranges for continuous variables. |
| Secondary | Percent change in splenomegaly | Every cycle (for clinical exam) and on day 1 of cycles 4 and 7 and at end of treatment (for computed tomography) (cycle length = 28 days) | Will be evaluated by clinical exam and on computed tomography. Statistical analyses will primarily be descriptive. All other safety and efficacy endpoints will be summarized using appropriate descriptive statistics, including counts and proportions for categorical variables and means, medians, standard deviations, and ranges for continuous variables. |
| Secondary | Changes in myeloproliferative neoplasm symptom burden | From baseline to day 1 of cycles 1, 2, and 4, and then every 3 cycles (cycle length = 28 days) | Changes in symptom burden will be evaluated using the Myelofibrosis Symptom Assessment Form total symptom score. Statistical analyses will primarily be descriptive. All other safety and efficacy endpoints will be summarized using appropriate descriptive statistics, including counts and proportions for categorical variables and means, medians, standard deviations, and ranges for continuous variables. |
| Secondary | Time to response | Up to 24 months | Will be analyzed using the Kaplan-Meier method, with median times and associated 95% confidence intervals estimated using the Brookmeyer-Crowley method. |
| Secondary | Duration of response | From date of response to date of first evidence of disease recurrence or treatment failure, assessed up to 24 months | Will be analyzed using the Kaplan-Meier method, with median times and associated 95% confidence intervals estimated using the Brookmeyer-Crowley method. |
| Secondary | Changes in packed red blood cell transfusion burden | Up to 24 months | Statistical analyses will primarily be descriptive. All other safety and efficacy endpoints will be summarized using appropriate descriptive statistics, including counts and proportions for categorical variables and means, medians, standard deviations, and ranges for continuous variables. |
| Secondary | Changes in bone marrow morphology and fibrosis | From baseline to day 1 of cycles 4 and 7 and at end of treatment (cycle length = 28 days) | Changes in bone marrow morphology will include cellularity and blast burden and fibrosis will be assessed by reticulin staining. Statistical analyses will primarily be descriptive. All other safety and efficacy endpoints will be summarized using appropriate descriptive statistics, including counts and proportions for categorical variables and means, medians, standard deviations, and ranges for continuous variables. |
| Secondary | Change in cytokine profile | From baseline to weeks 25 and 49 | Statistical analyses will primarily be descriptive. All other safety and efficacy endpoints will be summarized using appropriate descriptive statistics, including counts and proportions for categorical variables and means, medians, standard deviations, and ranges for continuous variables. |
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.
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