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
- 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,
- 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
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.
Masking: Open Label, Primary Purpose: Treatment
Arthur E. Frankel, MD
Scott and White Hospital & Clinic
United States: Food and Drug Administration
|Scott and White Cancer Institute||Temple, Texas 76508|