Trial · NCT07447817
Selinexor and Pacritinib in JAK Inhibitor-naïve MF Patients With Cytopenias
NCT07447817, Phase 2, Recruiting, John Mascarenhas
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Selinexor and Pacritinib in JAK Inhibitor-naïve MF Patients With Cytopenias. Trials, record NCT07447817. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07447817
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selinexor and Pacritinib in JAK Inhibitor-naïve MF Patients With Cytopenias
- NCT number
- NCT07447817
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 26 participants, estimated
- Lead sponsor
- John Mascarenhas
- Conditions
- Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
- Interventions
- Pacritinib, Selinexor
- First posted
- 2026-03-04
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in spleen volume | Baseline and 24 weeks | Evaluate clinical efficacy of pacritinib and selinexor in myelofibrosis patients who are JAK inhibitor-naïve and have anemia and thrombocytopenia by assessing spleen volume reduction (SVR) of 35% or greater compared to baseline as measured by imaging (MRI/CT) |
| Secondary | Spleen response rate | At 24 weeks and 48 weeks | Spleen response rate (by palpation) after 6 and 12 cycles; spleen response is defined as baseline splenomegaly palpable at 5-10cm that becomes not palpable, or baseline splenomegaly of \>10cm that decreases by ≥ 50%, as measured by palpation |
| Secondary | Change in the Myelofibrosis-Symptom Assessment Form Total Symptom Score (MF-SAF TSS) | At 24 weeks and 48 weeks | Evaluate change in patient reported outcomes of treatment Change in MF-SAF TSS from baseline after 6 and 12 cycles; symptom response will be determined in participants with baseline MF-SAF TSS ≥ 10. The MF-SAF TSS comprises 7 items measuring MF-related symptoms. Each item is scored on a scale ranging from 0 (absent) to 10 (worst imaginable) and the items are summed for a total score. The Mf-SAF TSS is the summation of all the individual scores (0-70 scale). Symptoms response requires ≥50% reduction in the MPN-SAF TSS and will be evaluable only in patients with a baseline TSS \>= 10. |
| Secondary | Change in Patient Global Impression of Change (PGIC) | At 24 weeks and 48 weeks | Patient Global Impression of Change (PGIC) response after 6 and 12 cycles; PGIC response is defined as "minimally improved" or better The Patient Global Impression of Change (PGIC) will be used to assess self-reported belief about the efficacy of treatment. PGIC is a 7-point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse. Total scale from 1-7, with higher score indicating poorer health outcomes. |
| Secondary | Anemia response | At 24 weeks and 48 weeks | Anemia response after 6 and 12 cycles; anemia response is determined according to revised 2024 International Working Group-European LeukemiaNet (IWG-ELN) criteria and includes major response rate and minor response rate for transfusion-dependent anemia. Major response: No transfusions for 12 weeks alongside a 12-week average hemoglobin increase of 150g/L Minor response: A 50% or more reduction in transfusions and failure to meet major response thresholds. |
| Secondary | Change in hemoglobin level | Continuously across all cycles of treatment, up to 48 weeks | Hemoglobin is the protein molecule in red blood cells that carries oxygen from the lungs to the body's tissues and returns carbon dioxide from the tissues back to the lungs. |
| Secondary | Change in platelet count | Continuously across all cycles of treatment, up to 48 weeks | Platelets are part of the blood cells. Platelets are a part of the blood clotting system and help in preventing bleeding. |
| Secondary | Progression-free survival | At time of disease progression or at 48 weeks, whichever occurs first | Progression-free survival (PFS) is defined as time from first treatment to disease progression by IWG-ELN criteria |
| Secondary | Overall survival | At time of death or censored at last follow-up, at 48 weeks | Overall survival (OS) is defined as time from first treatment to death due to any cause or censored at last follow-up |
| Secondary | Number of participants achieving RBC transfusion independence) | at 24 weeks and at 48 weeks | The number of participants achieving transfusion independence will be divided by the number of participants who were transfusion-dependent at baseline |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P01CA108671 | Myeloproliferative Neoplasms-Research Consortium | HOFFMAN, RONALD | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | NATIONAL CANCER INSTITUTE | 2006 to 2025 |
Source NIH RePORTER
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/NCT07447817
GET https://conductscience.org/api/trials/v1/NCT07447817/registered