PACIFICA Trial - Eligibility Criteria

Study Design

^aUp to 270 days of low-dose ruxolitinib or up to 90 days of any JAK inhibitor.

^bA 2-week washout will be required for MF directed therapy and at least 28 days for experimental MF therapies.

^cPhysician’s Choice therapy includes low-dose ruxolitinib (no more than 10 mg/day), danazol, corticosteroids, or hydroxyurea.

BID=twice daily; DIPSS=Dynamic International Prognostic Scoring System; JAK=Janus kinase; MF=myelo brosis; PET-MF=post-essential thrombocythemia MF; PGIC=patient global impression of change; PMF=primary MF; PPV-MF=post-polycythemia vera MF; SVR=spleen volume reduction; TSS=total symptom score.

Trial Eligibility Criteria

Key Inclusion Criteria
- Adults with primary or secondary MF
- Platelet count <50,000/μL
- DIPSS Int-1/-2 or High Risk
- Palpable spleen ≥5cm
- TSS ≥10 on the MPN-SAF v2.0
- ECOG performance status 0-2
- LVEF ≥50%
- Peripheral blasts <10%
- Adequate hepatic and renal function, coagulation parameters and neutrophil count
Key Exclusion Criteria
- Prior splenectomy or allogeneic HSCT
- Any MF therapy within 14 days
- Prior treatment with more than one JAK2 inhibitor*
- Grade ≥2 bleeding within prior 3 months unless caused by an event
- Medications that increase bleeding risk within 14 days
- Grade ≥2 cardiac conditions within 6 months
- QTc >450ms or medicines that prolong QT within 14 days
- NYHA Class II-IV heart failure
- Active bowel disorders
- Non-MF malignancy within 3 years
*Current or prior JAK2 inhibitor patients may be eligible if this treatment meets at least one of the following criteria:

Prior treatment with any JAK2 inhibitor, irrespective of dose, with a duration of 90 days or less.

Prior treatment with ruxolitinib, at no more than 10 mg total daily dose on any day, with a duration of 270 days or less.

PACIFICA Trial Study Design & Eligibility Criteria

Study Design

Trial Eligibility Criteria

For full eligibility criteria visit:

PACIFICA Trial Study Design & Eligibility Criteria

Study Design

Trial Eligibility Criteria

For full eligibility criteria visit:

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