Pacritinib Before Transplant for Myeloproliferative Neoplasms (MPN)

• Status: Terminated
• Trial end date: 2017-01-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: CTI BioPharma
• Treatments: Busulfan; Fludarabine; Fludarabine phosphate; Vidarabine

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.