Pacritinib Before Transplant for Myeloproliferative Neoplasms (MPN)

Conditions

• Myeloproliferative Diseases

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Pacritinib — DRUG
  200 mg by mouth twice a day for 60 days.
• Busulfan — DRUG
  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 — BEHAVIORAL
  Questionnaires completed at baseline, 1, 3, 6, and 12 months after transplant.
• Phone Calls — BEHAVIORAL
  Phone calls made by study staff to participant on second and third week of each month.
• Allogeneic Stem Cell Transplantation — PROCEDURE
  Allogeneic stem cell transplantation (Allo TP) 60 days after starting Pacritinib but not more than 180 days.
• Fludarabine — DRUG
  Fludarabine taken along with Busulfan as per standard of care as preparative regimen for allogeneic stem cell transplantation (Allo TP).

Study Details

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.

Key Dates

Start date

Jun 15, 2015

Status verified

Oct 2018

Primary completion

Jan 20, 2017

Completion

Jan 20, 2017

Study Design

Enrollment

4 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

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. ]

Locations (1)

Find similar trials in Houston, TX

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