Hu8F4 in Treating Patients with Advanced Hematologic Malignancies

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Leukemia Myelodysplastic Syndromes (MDS)	NCT ID:	NCT02530034
Trial Phases:	Phase I	Protocol IDs:	2014-0057 (primary) NCI-2015-02131 P-TRP-2447-14
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	M D Anderson Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT02530034

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.

Objectives

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.

Treatment Sites in Georgia

Augusta University Medical Center
1120 15th Street
Augusta, GA 30912
706-721-4430
www.augustahealth.org

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