Pacritinib Before Transplant for Myeloproliferative Neoplasms (MPN)

NCT02410551 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-10-30

Study results available
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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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02410551 on ClinicalTrials.gov