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Trial record 1 of 1 for:    02410551
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Pacritinib Before Transplant for Myeloproliferative Neoplasms (MPN)

This study has been terminated.
Sponsor:
Collaborator:
CTI BioPharma
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT02410551
First received: April 2, 2015
Last updated: January 23, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Myeloproliferative Diseases Drug: Pacritinib Drug: Busulfan Behavioral: Questionnaires Behavioral: Phone Calls Procedure: Allogeneic Stem Cell Transplantation Drug: Fludarabine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Pacritinib Prior to Transplant for Patients With Myeloproliferative Neoplasms (MPN)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: 1 year ]
    Progression-free survival defined as the time of stem-cell transplant to the time of death or disease progression.


Secondary Outcome Measures:
  • Neutrophil Engraftment [ Time Frame: 3 weeks after transplant ]
    Neutrophil engraftment defined as a sustained ANC > 0.5 x 109/L for 3 consecutive days and evidence of donor chimerism by D+28.

  • Platelet Engraftment [ Time Frame: 1 month ]
    Platelet engraftment defined as a sustained first of three consecutive laboratory values of platelet ³ 20x109/L with no platelet transfusions administered for 7 consecutive days.


Enrollment: 4
Actual Study Start Date: June 15, 2015
Study Completion Date: January 20, 2017
Primary Completion Date: January 20, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Other Names:
  • Busulfex
  • Myleran
Behavioral: Questionnaires
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
Drug: Fludarabine
Fludarabine taken along with Busulfan as per standard of care as preparative regimen for allogeneic stem cell transplantation (Allo TP).
Other Names:
  • Fludarabine phosphate
  • Fludara

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with Idiopathic Myelofibrosis or Myelofibrosis secondary to Polycythemia Vera or Essential Thrombocythemia.
  2. Patients 18 years to less than or equal to 70 years.
  3. Patients wanting to pursue transplant.
  4. Patients must have a Zubrod PS equal or less than 2.
  5. Calculated creatinine clearance greater than 50ml/min. using the Cockcroft-Gault equation.
  6. Ejection fraction equal or above 40%.
  7. Serum direct bilirubin less than 1 mg/dl (unless due to Gilbert's syndrome or hemolysis).
  8. SGPT equal or less than 4 x normal values.
  9. Corrected DLCO equal or above 50% of expected.
  10. 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.

Exclusion Criteria:

  1. Patients with low risk myelofibrosis.
  2. Uncontrolled life-threatening infections.
  3. HIV positive.
  4. Patients with active viral hepatitis.
  5. Prior treatment with Pacritinib.
  6. Prior stem cell transplant.
  7. QTc greater than 450 ms.
  8. CYP3A4 strong or moderate inhibitors/inducers in the past 7 days.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02410551

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
CTI BioPharma
Investigators
Principal Investigator: Uday Popat, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02410551     History of Changes
Other Study ID Numbers: 2014-0786
NCI-2015-01123 ( Registry Identifier: NCI CTRP )
Study First Received: April 2, 2015
Last Updated: January 23, 2017

Keywords provided by M.D. Anderson Cancer Center:
Myeloproliferative Diseases
Myeloproliferative Neoplasms
MPN
Myelofibrosis
Polycythemia vera
PV
Essential thrombocythemia
Allogeneic stem cell transplantation
Allo TP
Pacritinib
Busulfan
Busulfex
Myleran
Questionnaires
Surveys
Phone calls

Additional relevant MeSH terms:
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Fludarabine
Fludarabine phosphate
Busulfan
Vidarabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Alkylating Agents
Antineoplastic Agents, Alkylating
Myeloablative Agonists

ClinicalTrials.gov processed this record on July 26, 2017