Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
46

Summary

Conditions
  • Acute Myeloid Leukemia With Multilineage Dysplasia
  • Blasts 20-30 Percent of Bone Marrow Nucleated Cells
  • Blasts 20-30 Percent of Peripheral Blood White Cells
  • Chronic Myelomonocytic Leukemia
  • High Risk Myelodysplastic Syndrome
  • IPSS Risk Category Intermediate-2
  • Myelodysplastic Syndrome
Type
Interventional
Phase
Phase 1Phase 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. To determine the safety, tolerability and clinical activity of glutaminase inhibitor CB-839 (CB-839) in combination with azacitidine (AZA) for patients with advanced myelodysplastic syndrome (MDS). SECONDARY OBJECTIVES: I. To explore the pharmacokinetics (PK) of CB-839 in comb...

PRIMARY OBJECTIVES: I. To determine the safety, tolerability and clinical activity of glutaminase inhibitor CB-839 (CB-839) in combination with azacitidine (AZA) for patients with advanced myelodysplastic syndrome (MDS). SECONDARY OBJECTIVES: I. To explore the pharmacokinetics (PK) of CB-839 in combination with AZA. II. To explore the pharmacodynamics (PDn) of CB-839 in combination with AZA. III. To assess overall survival, event-free survival and duration of response of CB-839 in combination with AZA. OUTLINE: Patients receive glutaminase inhibitor CB-839 orally (PO) twice daily (BID) on days 1-28 and azacitidine subcutaneously (SC) or intravenously (IV) over 10-40 minutes on days 1-7. After completion of study treatment, patients are followed up at 28 days.

Tracking Information

NCT #
NCT03047993
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Courtney DiNardo M.D. Anderson Cancer Center
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