Trial · NCT04517851
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response (OR) | Up to completion of cycle 36 (1 cycle is 28 days) | OR is defined as CR (complete response) +PR (partial response) + CI (clinical improvement), where CI includes clinical improvements in anemia, splenomegaly and/or symptoms. Will estimate the OR rate, along with the exact 95% confidence interval. |
| Secondary | Incidence of adverse events | Up to 30 days post-treatment | The method of Thall, Simon and Estey will be used to monitor for safety. The severity of the toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 whenever possible. Will follow standard reporting guidelines for adverse events. Safety data will be summarized by category, severity and frequency. |
| Secondary | Duration of response | Up to 5 years | The Kaplan-Meier method will be used to estimate the duration of response where median and 95% confidence interval will be reported. |
| Secondary | Time to next treatment | Up to 5 years | The Kaplan-Meier method will be used to estimate the time to next treatment where median and 95% confidence interval will be reported. |
| Secondary | Rates of complete response | Up to 5 years | |
| Secondary | Rates of partial response | Up to 5 years | |
| Secondary | Rates of clinical improvement | Up to 5 years | |
| Secondary | Platelet response rate | Up to 5 years | |
| Secondary | Changes in bone marrow fibrosis grade | Baseline up to 5 years | Will be assessed according to European classification. |
| Other | Biomarker analysis | Up to 5 years | Fisher's exact test will be used to assess the associations between biomarker expression (high versus low) and outcomes. Wilcoxon singed rank test will be applied to assess the change of biomarkers from baseline. |
| Other | Percentage of circulating SLAMF7high/CD16neg monocytes | Baseline and over time up to 5 years | |
| Other | Serum IL-1Ralpha levels | Baseline and over time up to 5 years | |
| Other | JAK2V617F allele burden in the bone marrow or blood | Baseline and over time up to 5 years | |
| Other | Myeloid mutation panel (81-gene next generation sequencing panel) on serial bone marrow aspirates | Up to 5 years |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04517851/registered