Pacritinib Before Transplant for Myeloproliferative Neoplasms (MPN)
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|ClinicalTrials.gov Identifier: NCT02410551|
Recruitment Status : Terminated
First Posted : April 7, 2015
Results First Posted : October 5, 2018
Last Update Posted : October 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Myeloproliferative Diseases||Drug: Pacritinib Drug: Busulfan Behavioral: Questionnaires Behavioral: Phone Calls Procedure: Allogeneic Stem Cell Transplantation Drug: Fludarabine||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pacritinib Prior to Transplant for Patients With Myeloproliferative Neoplasms (MPN)|
|Actual Study Start Date :||June 15, 2015|
|Actual Primary Completion Date :||January 20, 2017|
|Actual Study Completion Date :||January 20, 2017|
Experimental: Pacritinib + Allogeneic Stem Cell Transplantation
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.
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.
Other Name: Surveys
Behavioral: Phone Calls
Phone calls made by study staff to participant on second and third week of each month.
Procedure: Allogeneic Stem Cell Transplantation
Allogeneic stem cell transplantation (Allo TP) 60 days after starting Pacritinib but not more than 180 days.
Other Name: Stem cell transplant
Fludarabine taken along with Busulfan as per standard of care as preparative regimen for allogeneic stem cell transplantation (Allo TP).
- Progression-free Survival (PFS) [ Time Frame: 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. ]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.
- Evaluate Safety and Efficacy of Pacritinib. [ Time Frame: Start of Pacritinib to one year post transplant ]Evaluate safety and efficacy of this therapy determined by Neutrophil and platelet engraftment, Non-relapse mortality at one year post transplant, Overall survival at one year post transplant, Liver and spleen response to Pacritinib, Immune recovery, quality of life and symptom score, Primary and secondary graft failure,Complete remission, Relapse.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410551
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Uday Popat, MD||M.D. Anderson Cancer Center|