Trial · NCT06514807
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Durable (for at least 3 months) peripheral blood count remission | At month 12 | PLTs ≤400 x 109/L AND WBC \<10 x 109/L |
| Primary | Absence of haemorrhagic or thrombotic events and absence of disease progression* | At month 12 | \*Progression is defined as conversion from asymptomatic to symptomatic splenomegaly or clinically relevant progression of spleen size at the Investigator's discretion, respectively. |
| Primary | Absence or Non-progression* in disease-related signs | At month 12 | \*Progression is defined as conversion from asymptomatic to symptomatic splenomegaly or clinically relevant progression of spleen size at the Investigator's discretion, respectively. |
| Primary | Durable (for at least 3 months) large symptoms improvement or maintenance of non-progression based on the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)# | At month 12 | \# Large symptoms improvement for ET patients is defined as follows: * Baseline TSS ≥20: 10-points reduction in TSS * Baseline TSS 15-19, inclusive: 5-points reduction in TSS * Baseline TSS 10-14, inclusive: TSS decreases to ≤10 * Baseline TSS \<10: TSS stays \<10 |
| Secondary | Response at month 9, 18, 24, 30 and 36 | Month 9, 18, 24, 30 and 36 | |
| Secondary | Longitudinal changes in the ELN response rates over 12 months | up to 36 months | |
| Secondary | Time to first response (as defined by ELN criteria) | up to 36 months | |
| Secondary | Duration of first response (as defined by ELN criteria) | up to 36 months | |
| Secondary | Duration of first durable response (as defined by ELN criteria) | up to 36 months | |
| Secondary | Time to first peripheral blood count remission response | up to 36 months | |
| Secondary | Duration of first durable peripheral blood count remission response | up to 36 months | |
| Secondary | Occurrence of thromboembolic and bleeding events response | up to 36 months | |
| Secondary | Occurrence of disease progression response | up to 36 months | |
| Secondary | Symptomatic improvement assessed by EQ-5D-5L questionnaire response | up to 36 months | |
| Secondary | Symptomatic improvement assessed by the 10-item MPN-SAF TSS | up to 36 months | |
| Secondary | Change in inflammation markers over time | up to 36 months | |
| Secondary | Change in CALR, MPL, or JAK2 allelic burden over time | up to 36 months | |
| Other | Safety endpoints | up to 36 months | Adverse events (AEs), according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) |
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/NCT06514807/registered