A Study of Parsaclisib in Combination With Ruxolitinib to Treat Subjects with Myelofibrosis

Overview

About this study

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of the combination of parsaclisib and ruxolitinib in subjects with myelofibrosis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.
  • Palpable spleen of > 10 cm below the left subcostal margin on physical examination at the screening visit.
  • Palpable splenomegaly of 5 to 10 cm below left subcostal margin on physical exam AND active symptoms of MF at the screening visit as demonstrated by presence of 1 symptom score ≥ 5 or 2 symptom scores ≥ 3 using the Screening Symptom Form.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

Exclusion Criteria:

  • Use of experimental drug therapy for myelofibrosis, or any other standard drug (e.g., danazol, hydroxyurea, etc) with the exception of ruxolitinib within 6 months of starting study (combination) therapy and/or lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade 1 or better.
  • Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
  • Unwillingness to be transfused with blood components.
  • Recent history of inadequate bone marrow reserve as demonstrated by the following:
    • Platelet count < 50 × 10^9/L in the 4 weeks before screening or platelet transfusion(s) within 8 weeks before screening;
    • Absolute neutrophil count levels < 0.5 × 10^9/L in the 4 weeks before screening;
    • Subjects with peripheral blood blast count of > 10% at the screening or baseline hematology assessments;
    • Subjects who are not willing to receive red blood cell (RBC) transfusions to treat low hemoglobin levels.
  • Inadequate liver function at screening as demonstrated by the following:
    • Direct bilirubin ≥ 2.0 × the upper limit of laboratory normal (ULN);
      • NOTE: direct bilirubin will only be determined if total bilirubin is ≥ 2.0 × ULN.  
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × ULN - Inadequate renal function at screening as demonstrated by creatinine clearance < 50 mL/min or glomerular filtration rate < 50 mL/min/1.73 m^2.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Jeanne Palmer, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Jeanne Palmer, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jeanne Palmer, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions