Open-label Study of IMGN779 in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia

Study Identifier
IMGN779 0601
CT.gov Identifier
NCT02674763
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Blood Cancer - Acute Myeloid Leukemia (AML)
    • Study Drug
  • IMGN779
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Dose Escalation: Patients with relapsed or refractory AML * Dose Expansion: Patients with relapsed AML or patients who refuse, or are not suitable candidates for induction therapy
    Exclusion Criteria:
    * Dose Escalation: Acute Promyelocytic Leukemia * Any concurrent anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational agents (with the exception of hydroxyurea or leukapheresis for control of hyperleukocytosis) within 14 days or five half-lives of drugs, whichever is shorter, prior to Cycle 1 Day 1 * AML patients with known, active leptomeningeal/central nervous system (CNS) involvement * Prior treatment with IMGN779 * Women who are pregnant or breast feeding

    Protocol Summary

    This is an open label, multicenter Phase 1 study to determine the MTD, dosing schedule and RP2D of IMGN779 when administered as mono-therapy to adult AML patients with CD33 -positive disease.

    Study Locations

    Location
    Status
    Location
    Comprehensive Cancer Center (UAB CCC)
    Birmingham, Alabama, United States, 35294
    Status
    Not applicable
    Location
    Dana-Farber Cancer Institute
    Boston, Massachusetts, United States, 02215
    Status
    Not applicable
    Location
    New Mexico Cancer Care Alliance
    Albuquerque, New Mexico, United States, 87106
    Status
    Not applicable
    Location
    Roswell Park Cancer Institute
    Buffalo, New York, United States, 14263
    Status
    Not applicable
    Location
    Knight Cancer Institute - OSHU
    Portland, Oregon, United States, 97239
    Status
    Not applicable
    Location
    Baylor Scott & White University Medical Center
    Dallas, Texas, United States, 75246
    Status
    Not applicable
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