Clinical trial · Interventional
Pacritinib Before Transplant for Myeloproliferative Neoplasms (MPN)
Pacritinib Prior to Transplant for Patients With Myeloproliferative Neoplasms (MPN)
NCT02410551CI-TRIAL-00035517terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if giving pacritinib before standard of care drugs followed by an allogeneic stem cell transplant can help to control myeloproliferative neoplasms. The safety of this therapy will also be studied.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloproliferative Diseases | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Busulfan | Drug | Busulfan | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Pacritinib | Drug | Pacritinib | ALIAS |
| Phone Calls | Behavioral | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pacritinib + Allogeneic Stem Cell Transplantation
- description
- Participants start Pacritinib 200 mg by mouth twice a day. Participants proceed to transplant after 60 days of Pacritinib but not more than 180 days. Pacritinib stopped 21 days prior to starting preparative regimen for standard of care stem cell transplantation (SOC Allo TP). SOC transplant conditioning with Fludarabine and Busulfan AUC of 4000 microMol-min per day providing that pharmacokinetic can be done, otherwise Busulfan dose given as a fixed dose of 100 mg/m2 daily for four days. Questionnaires about symptoms and quality of life completed at baseline, 1, 3, 6, and 12 months after transplant. Phone calls made by study staff to participant on second and third week of each month.
- interventionNames
- Drug: Pacritinib
- Drug: Busulfan
- Behavioral: Questionnaires
- Behavioral: Phone Calls
- Procedure: Allogeneic Stem Cell Transplantation
- Drug: Fludarabine
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- participants who received Pacritinib for >/= 60 days but less than 180 days who undergo transplant with a matched related or at least 7/8 matched unrelated donor. The protocol was to evaluate progression free survival at one year.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with Idiopathic Myelofibrosis or Myelofibrosis secondary to Polycythemia Vera or Essential Thrombocythemia. 2. Patients 18 years to less than or equal to 70 years. 3. Patients wanting to pursue transplant. 4. Patients must have a Zubrod PS equal or less than 2. 5. Calculated creatinine clearance greater than 50ml/min. using the Cockcroft-Gault equation. 6. Ejection fraction equal or above 40%. 7. Serum direct bilirubin less than 1 mg/dl (unless due to Gilbert's syndrome or hemolysis). 8. SGPT equal or less than 4 x normal values. 9. Corrected DLCO equal or above 50% of expected. 10. Negative Beta HCG test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) and if fertile, males and females must agree to use contraceptives. Exclusion Criteria: 1. Patients with low risk myelofibrosis. 2. Uncontrolled life-threatening infections. 3. HIV positive. 4. Patients with active viral hepatitis. 5. Prior treatment with Pacritinib. 6. Prior stem cell transplant. 7. QTc greater than 450 ms. 8. CYP3A4 strong or moderate inhibitors/inducers in the past 7 days.
References
Publications (0)
Data not yet available
No reference posted for this study.