Pacritinib Before Transplant for Myeloproliferative Neoplasms (MPN)
NCT02410551 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2018-10-30
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.
Conditions
- Myeloproliferative Diseases
Interventions
- DRUG
-
Pacritinib
200 mg by mouth twice a day for 60 days.
- DRUG
-
Busulfan
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.
- BEHAVIORAL
-
Questionnaires
Questionnaires completed at baseline, 1, 3, 6, and 12 months after transplant.
- 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.
- DRUG
-
Fludarabine taken along with Busulfan as per standard of care as preparative regimen for allogeneic stem cell transplantation (Allo TP).
Sponsors & Collaborators
-
CTI BioPharma
collaborator INDUSTRY -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Uday Popat, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-06-15
- Primary Completion
- 2017-01-20
- Completion
- 2017-01-20
Countries
- United States
Study Locations
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