Hu8F4 in Treating Patients With Advanced Hematologic Malignancies

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Anemia, Refractory, with Excess of Blasts
Blast Crisis
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Hematologic Neoplasms
Hematopoietic and Lymphoid Cell Neoplasm
High Risk Myelodysplastic Syndrome
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Myelodysplastic Syndrome With Excess Blasts-1
Myelodysplastic Syndrome With Excess Blasts-2
Myelodysplastic Syndromes
Myelofibrosis
Preleukemia
Recurrence
Recurrent Acute Myeloid Leukemia
Recurrent Chronic Myelomonocytic Leukemia
Refractory Chronic Myelomonocytic Leukemia
Secondary Acute Myeloid Leukemia
Syndrome

Clinical Trial Details

NCT number	NCT02530034
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	January 31, 2019
Completion date	January 30, 2024

View Details

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