Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
40

Summary

Conditions
  • Anemia
  • Myelodysplastic/Myeloproliferative Neoplasm
  • Myelofibrosis
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: I. Determine safety and efficacy of sotatercept as therapy for persons with myeloproliferative neoplasm (MPN)-associated myelofibrosis and anemia. OUTLINE: This is a dose-escalation study. Patients receive sotatercept subcutaneously (SC) once every 3 weeks. Cycles repeat every 3 ...

PRIMARY OBJECTIVES: I. Determine safety and efficacy of sotatercept as therapy for persons with myeloproliferative neoplasm (MPN)-associated myelofibrosis and anemia. OUTLINE: This is a dose-escalation study. Patients receive sotatercept subcutaneously (SC) once every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients unable to achieve anemia-response after 8 cycles will be taken off study. After completion of study treatment, patients are followed up at 1 month.

Tracking Information

NCT #
NCT01712308
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Prithviraj Bose M.D. Anderson Cancer Center