Pacritinib Before Transplant for Myeloproliferative Neoplasms (MPN)
Pacritinib Prior to Transplant for Patients With Myeloproliferative Neoplasms (MPN)
2 other identifiers
interventional
4
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2015
CompletedFirst Posted
Study publicly available on registry
April 7, 2015
CompletedStudy Start
First participant enrolled
June 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2017
CompletedResults Posted
Study results publicly available
October 5, 2018
CompletedOctober 30, 2018
October 1, 2018
1.6 years
April 2, 2015
February 28, 2018
October 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
The protocol was to enroll at least 21 evaluable participants, defined as patients who received Pacritinib for \>/=60 days but less than 180 days. We enrolled four participants, however all four were not evaluable since no one was able to complete 60 days of Pacritinib.
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.
Other Outcomes (1)
Evaluate Safety and Efficacy of Pacritinib.
Start of Pacritinib to one year post transplant
Study Arms (1)
Pacritinib + Allogeneic Stem Cell Transplantation
EXPERIMENTALParticipants 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.
Interventions
200 mg by mouth twice a day for 60 days.
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 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.
Allogeneic stem cell transplantation (Allo TP) 60 days after starting Pacritinib but not more than 180 days.
Fludarabine taken along with Busulfan as per standard of care as preparative regimen for allogeneic stem cell transplantation (Allo TP).
Eligibility Criteria
You may qualify if:
- Patients with Idiopathic Myelofibrosis or Myelofibrosis secondary to Polycythemia Vera or Essential Thrombocythemia.
- Patients 18 years to less than or equal to 70 years.
- Patients wanting to pursue transplant.
- Patients must have a Zubrod PS equal or less than 2.
- Calculated creatinine clearance greater than 50ml/min. using the Cockcroft-Gault equation.
- Ejection fraction equal or above 40%.
- Serum direct bilirubin less than 1 mg/dl (unless due to Gilbert's syndrome or hemolysis).
- SGPT equal or less than 4 x normal values.
- Corrected DLCO equal or above 50% of expected.
- 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.
You may not qualify if:
- Patients with low risk myelofibrosis.
- Uncontrolled life-threatening infections.
- HIV positive.
- Patients with active viral hepatitis.
- Prior treatment with Pacritinib.
- Prior stem cell transplant.
- QTc greater than 450 ms.
- CYP3A4 strong or moderate inhibitors/inducers in the past 7 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- CTI BioPharmacollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Popat,Uday,M.D. / Stem Cell Transplantation
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Uday Popat, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2015
First Posted
April 7, 2015
Study Start
June 15, 2015
Primary Completion
January 20, 2017
Study Completion
January 20, 2017
Last Updated
October 30, 2018
Results First Posted
October 5, 2018
Record last verified: 2018-10