NCT00397579

DT388IL3 Fusion Protein in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

Therapy Targeting the Interleukin-3 Receptor (IL3R) for Patients With Relapsed or Refractory and Elderly or Poor-Risk Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome With DTIL3 (IND# 11314): a Phase I/II Clinical Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Combinations of biological substances in DT388IL3 fusion protein may be able to carry cancer killing substances directly to the cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of DT388IL3 fusion protein and to see how well it works in treating patients with acute myeloid leukemia or myelodysplastic syndromes.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose of DT\_388IL3 fusion protein in patients with refractory or relapsed or poor-risk acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS). * Define the dose-limiting toxicities of this regimen in these patients. * Measure the pharmacokinetics of this regimen in these patients. * Measure the immune responses in patients treated with this regimen. * Evaluate response and correlate with disease type (relapsed/refractory or poor-risk de novo AML or high-risk MDS), pretreatment marrow blast percentage, and leukemia blast interleukin-3 receptor density. OUTLINE: This is a phase I, multicenter, dose-escalation study followed by a phase II, open-label study. * Phase I: Patients receive DT\_388IL3 IV over 15 minutes daily for 5 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of DT\_388IL3 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. * Phase II: An additional 15 patients receive DT\_388IL3 at the MTD as in phase I. Patients undergo serum and blast collection periodically for laboratory studies, including analysis of expression of interleukin-3 receptors and anti-DT\_388IL3 antibodies at baseline. Samples are also analyzed by immunoenzyme assays and flow cytometry. After completion of study treatment, patients are followed periodically for up to 5 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Conditions

• Leukemia
• Myelodysplastic Syndromes
• Blastic Plasmacytoid Dendritic Cell Neoplasm

Interventions

Type	Name	Description
DRUG	DT388IL3	Intravenously via a 3 cc plastic syringe as a 15 minute bolus infusion daily for five days.

Timeline

• Start date: 2013-05-01
• Primary completion: 2017-07-27
• Completion: 2017-07-27
• First posted: 2006-11-09
• Last updated: 2019-04-23
• Results posted: 2019-04-23

Locations

1 site across 1 country: United States