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

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT02674763

Run by

ImmunoGen, Inc.

People needed

62

Starts

2016-03-01

Expected to finish

2019-07-01

Last updated by the study team

2019-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Comprehensive Cancer Center (UAB CCC) — Birmingham, Alabama, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• New Mexico Cancer Care Alliance — Albuquerque, New Mexico, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Knight Cancer Institute - OSHU — Portland, Oregon, United States
• Baylor Scott & White University Medical Center — Dallas, Texas, United States
• The University of Texas, MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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