Hu8F4 in Treating Patients With Advanced Hematologic Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 60
Summary
- Conditions
- Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
- Hematopoietic and Lymphoid Cell Neoplasm
- High Risk Myelodysplastic Syndrome
- Myelodysplastic Syndrome With Excess Blasts-1
- Myelodysplastic Syndrome With Excess Blasts-2
- Myelofibrosis
- Recurrent Acute Myeloid Leukemia
- Recurrent Chronic Myelomonocytic Leukemia
- Refractory Chronic Myelomonocytic Leukemia
- Secondary Acute Myeloid Leukemia
- Type
- Interventional
- Phase
- Phase 1
- 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 dose limiting toxicity (DLT) and minimum safe and biologically-effective dose of Hu8F4 when administered intravenously in patients with leukemia or myelodysplastic syndrome (MDS). II. To determine the pharmacokinetics (PK) of Hu8F4 following study drug adminis...
PRIMARY OBJECTIVES: I. To determine the dose limiting toxicity (DLT) and minimum safe and biologically-effective dose of Hu8F4 when administered intravenously in patients with leukemia or myelodysplastic syndrome (MDS). II. To determine the pharmacokinetics (PK) of Hu8F4 following study drug administration. SECONDARY OBJECTIVES: I. To observe the anti-leukemia effects of Hu8F4 in patients with leukemias and MDS. II. To measure the overall survival, disease-free survival and event-free survival of patients with leukemias or MDS treated with Hu8F4. OUTLINE: This is a dose-escalation study. Patients receive anti-PR1/HLA-A2 monoclonal antibody Hu8F4 intravenously (IV) over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Tracking Information
- NCT #
- NCT02530034
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Tapan M Kadia M.D. Anderson Cancer Center
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