Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT02530034
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-24
First Post:
2015-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hu8F4 in Treating Patients With Advanced Hematologic Malignancies
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase I Study of Hu8F4 in Patients With Advanced Hematologic Malignancies
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2015-02131 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| P-TRP-2447-14 | None | None | View | |
| 2014-0057 | OTHER | M D Anderson Cancer Center | View | |
| P50CA100632 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2015-02131 | OTHER | NCI-CTRP Clinical Trials Reporting Registration | View |