Trial · NCT07394153
Pacritinib For Bone Marrow Fibrosis In Patients With Myelofibrosis Who Have Thrombocytopenia
NCT07394153, Phase 2, Recruiting, Grupo Español de Enfermedades Mieloproliferativas Crónicas PH Negativas
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pacritinib For Bone Marrow Fibrosis In Patients With Myelofibrosis Who Have Thrombocytopenia. Trials, record NCT07394153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07394153
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pacritinib For Bone Marrow Fibrosis In Patients With Myelofibrosis Who Have Thrombocytopenia
- NCT number
- NCT07394153
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Grupo Español de Enfermedades Mieloproliferativas Crónicas PH Negativas
- Conditions
- Myelofibrosis，MF
- Interventions
- Pacritinib
- First posted
- 2026-02-06
- Last updated
- 2026-10-02
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Decrease in reticulin fibrosis in bone marrow (BM) | from baseline to week 52 after first dose of study treatment | Measured in BM biopsy. Percentage of patients who experience a decrease of ≥1 grade in reticulin fibrosis from baseline to week 52. Definition of BM fibrosis grade will follow the European consensus that ranges from 0 (scattered, less fibrotic) to 3 (difuse and dense reticulin, more fibrotic). Patients will be classified as improvement (fibrosis decrease ≥1 grade), no change, or worsening (fibrosis increase \> 1 grade). |
| Secondary | Improvement in BM fat fraction (FF) | from baseline to week 52 after first dose of study treatment | measured by quantitative quantitative Dixon Quant MRI or equivalent. Changes in the bone marrow associated with MF, such as replacement of the bone marrow fat by fibrosis or elevated numbers of hematopoietic cells, reduce the abundance of fat. Here we will report the percentage of patient who had an improvement in the FF (increase from baseline at week 52). |
| Secondary | red blood cell (RBC) transfusion independence | from baseline to week 24 and week 52 after first dose of study treatment | Percentage of patients who achieved no need of RBC transfusions during at least 12 week. RBC transfusion independence will be reported in subgroup of patients with the changes in the Bone Marrow (by MRI and/or BM biopsy) over the first 24 and 52 weeks of treatment. |
| Secondary | Improvement in hemoglobin level | from baseline to week 24 and week 52 after first dose of study treatment | Percentage of patients who improve their hemoglobin levels without transfusion. Improvement was defined as a ≥ 1.5 g/dL increase in hemoglobin from baseline. Changes in hemoglobin level without transfusion will be reported in subgroup of patients with the changes in the Bone Marrow (by MRI and/or BM biopsy) over the first 24 and 52 weeks of treatment. |
| Secondary | Improvement in platelet counts | from baseline to week 24 and week 52 after first dose of study treatment | increase of platelet count (without transfusions) in comparison to baseline of above 75 x 109/L (if platelet count was between 50 - 75 109/L at baseline) or above 100 x 109/L (if platelet count was between 75 - 100 x 109/L at baseline). Alternatively, the proportion of patients who increase platelet counts ≥25% above baseline will be measured. |
| Secondary | Myeloproliferative neoplasms (MPN) driver-gen Variant Allele Frequency (VAF) | Baseline and at Week 24 and Week 52 after the first dose of study treatment | JAK2, CALR, and MPL genes are drivers of myelofibrosis. Their VAF could be quantified in peripheral blood or bone marrow and its circulating levels are usually correlated with the course of the disease. We aim to find the percentage of patients who reduced their VAF at week 24 and 52. |
| Secondary | Cummulative dose | Throughout the study period, up to approximately 2 years | the sum of all doses of pacritinib taken from the start of study treatment, taken into consideration interruptions and reductions. |
| Secondary | Actual dose of pacritinib | Throughout the study period, up to approximately 2 years | defined as the real average daily dose administered. For its calculation, the cumulative dose will be divided by the duration of the treatment, considering also the interruption periods. |
| Secondary | Relative dose intensity of pacritinib | Throughout the study period, up to approximately 2 years | Defined as the percentage of the planned dose that has been actually administered. Calculated dividing actual dose by planned dose per day. |
| Secondary | Frequency of treatment-related adverse events | Throughout the study period, up to approximately 2 years | number of patients who experience a treatment-related adverse event. Events will be classified and graded according to National Cancer Institute (NCI) Common Terminology Criteria (CTCAE) version 5.0 |
Source ClinicalTrials.gov
Outcomes0
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.
Grants0
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.
None in this release.
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/NCT07394153
GET https://conductscience.org/api/trials/v1/NCT07394153/registered