Acute Myeloid Leukemia Clinical Trial

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

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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.

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Full Description

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.

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Eligibility 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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

62

Study ID:

NCT02674763

Recruitment Status:

Completed

Sponsor:

ImmunoGen, Inc.

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There are 7 Locations for this study

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Comprehensive Cancer Center (UAB CCC)
Birmingham Alabama, 35294, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
New Mexico Cancer Care Alliance
Albuquerque New Mexico, 87106, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Knight Cancer Institute - OSHU
Portland Oregon, 97239, United States
Baylor Scott & White University Medical Center
Dallas Texas, 75246, United States
The University of Texas, MD Anderson Cancer Center
Houston Texas, 77030, United States
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How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

62

Study ID:

NCT02674763

Recruitment Status:

Completed

Sponsor:


ImmunoGen, Inc.

How clear is this clinincal trial information?

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