Last updated on November 2019

A Phase 2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Myelofibrosis


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Myelodysplastic/Myeloproliferative Neoplasm | Acute myeloid leukemia | Myelodysplastic-Myeloproliferative Diseases | Unclassifiable | MYELODYSPLASTIC SYNDROME | Myelosclerosis with myeloid metaplasia | Myelofibrosis | Preleukemia
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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) 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.
  • Adequate hematological, renal, hepatic, and coagulation laboratory assessments
  • Patients must give written informed consent to participate in this study before the performance of any study-related procedure.

For Arm 1 and 2 the following criteria should be considered:

  • Palpable spleen 5 cm that is below the costal margin on physical examination OR RBC transfusion dependent (defined as an average of 2 units of RBC transfusions per month over the 12 weeks prior to enrollment)
  • At least 2 symptoms measurable (score 1) using the Myelofibrosis Symptom Assessment Form Version 4.0 (MFSAF v4.0)
  • Platelet count 75 x 10^9/L without the assistance of thrombopoietic factors or transfusions for at least 14 days
  • Monotherapy Arm (Arm 1): Previously treated with a JAK inhibitor and be intolerant, resistant, refractory or lost response to the JAK inhibitor
  • Combination Arm (Arm 2): Must have received single agent ruxolitinib and be on a stable dose for a minimum 8 weeks

For Arm 3 (JAK inhibitors nave) the following criteria should be considered:

  • Platelet count 100 x 10^9/L without the assistance of thrombopoietic factors or transfusions
  • Palpable spleen 5 cm that is below the costal margin on physical examination
  • At least 2 symptoms measurable (score 3) or a total score of 10 using the MFSAF v4.0
  • No prior treatment with JAKi allowed

Exclusion Criteria

  • Current known active or chronic infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C.
  • Impaired cardiac function or clinically significant cardiac diseases
  • 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.
  • Pregnant or lactating women
  • Any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study
  • Patients unwilling or unable to comply with this study protocol.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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