0610-02 (MANIFEST) (FL & R/R)

A phase 2 study of CPI0610, a small molecule inhibitor of BET proteins with/without ruxolitinib in patients with Myelofibrosis

Study treatments

(Arm 1B and 2B closed)

• Arm 1: Prior JAKi: CPI-0610 monotherapy 125mg QD d1-14 (1A = transfusion dependent (TD), 1B = not TD)
• Arm 2: Currently JAKi: combination CPI-0610 125mg QD d1-14 and Ruxolitinib (2A = TD, 2B = not TD)
•  Arm 3 : JAKi naïve: combination CPI-0610 125mg QD d1-14 and Ruxolitinib

Inclusion criteria

• Adult (aged ≥ 18 years)
• Phase 2 part: Patients with confirmed diagnosis of MF who meet all of the following criteria:
  • Dynamic International Prognostic Scoring System (DIPSS; see Appendix 3) risk category of intermediate-1 or higher.
  • ANC ≥ 1 x 10^9/L without the assistance of granulocyte growth factors
  • Peripheral blood blast count <10%
• ECOG performance status ≤ 2.

Exclusion criteria

• Patients with Child-Pugh Class B or C
• Impairment of gastrointestinal (GI) function or GI disease that could significantly alter the absorption of CPI-0610 and/or ruxolitinib, including any unresolved nausea, vomiting, or diarrhea that is CTCAE grade >1
• Prior treatment with a BET inhibitor.

Participating sites

• ZNA
• University Hospital Leuven Gasthuisberg