NCT02530034

Hu8F4 in Treating Patients With Advanced Hematologic Malignancies

Phase I Study of Hu8F4 in Patients With Advanced Hematologic Malignancies

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of anti-PR1/HLA-A2 monoclonal antibody Hu8F4 (Hu8F4) in treating patients with malignancies related to the blood (hematologic). Monoclonal antibodies, such as Hu8F4, may interfere with the ability of cancer cells to grow and spread.

Detailed 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 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.

Conditions

• Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
• Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• 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

Interventions

Type	Name	Description
DRUG	Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2019-01-31
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2015-08-20
• Last updated: 2026-01-07

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study