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



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:2/22/2019
Start Date:March 2016
End Date:December 2019
Contact:ImmunoGen Clinical Operations
Email:scientificaffairs@immunogen.com
Phone:781-895-0600

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A Phase 1, Multi-center, Open-label Study of IMGN779 Administered Intravenously in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia

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.

In the Dose Escalation Phase, patients will be assigned to one of three schedules. The MTD
for all schedules will be determined from the assessment of Dose Limiting Toxicities (DLTs).
The Dose Expansion Phase will consist of one cohort based on patients response to prior
therapy according to the MTD selected.

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
We found this trial at
7
sites
1824 6th Avenue South
Birmingham, Alabama 35294
Principal Investigator: Nikolaos Papadantonakis, MD
Phone: 205-975-2076
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Birmingham, AL
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Eunice Wang, MD
Phone: 716-845-4971
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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Albuquerque, New Mexico 87109
Principal Investigator: Cecilia Arana Yi, MD
Phone: 505-925-0390
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Albuquerque, NM
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Daniel Deangelo, MD
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Dallas, Texas 75246
Principal Investigator: Moshe Y Levy, MD
Phone: 214-818-8325
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Dallas, TX
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Jorge E Cortes, MD
Phone: 713-792-4937
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Portland, Oregon 97239
Principal Investigator: Elie Traer, MD
Phone: 503-494-5303
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Portland, OR
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