Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT02530034
Brief 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.
Study:
NCT02530034
Study Brief:
Protocol Section:
NCT02530034