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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.
Full description
OBJECTIVES:
OUTLINE: This is a phase I, multicenter, dose-escalation study followed by a phase II, open-label study.
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.
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.
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Histologically or morphologically confirmed acute myeloid leukemia (AML), meeting 1 of the following criteria:
Relapsed or refractory AML after treatment with ≥ 1 prior conventional induction therapy
Poor-risk AML, as defined by any of the following criteria:
High-risk myelodysplastic syndromes diagnosed by morphologic, histochemical, or cell surface marker criteria
Bone marrow index (i.e., percent cellularity × percent blasts) ≤ 40% at time of treatment
No active CNS leukemia
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Primary purpose
Allocation
Interventional model
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11 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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