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

This study is currently recruiting participants.
Verified September 2016 by ImmunoGen, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02674763
First Posted: February 4, 2016
Last Update Posted: September 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
ImmunoGen, Inc.
  Purpose
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.

Condition Intervention Phase
Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia Drug: IMGN779 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multi-center, Open-label Study of IMGN779 Administered Intravenously in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by ImmunoGen, Inc.:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of IMGN779 [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • Treatment emergent adverse events [ Time Frame: Up to 12 months ]
  • Objective Response Rate (ORR) (complete response [CR= CR+CRp+CRi]+partial remission [PR]) [ Time Frame: Up to 12 months ]
  • PK parameters: maximum plasma concentration (Cmax) of IMGN779 [ Time Frame: up to 12 months ]
  • PK parameters: area under the time-concentration curve (AUC) of IMGN779 [ Time Frame: Up to 12 months ]
  • PK parameters: terminal half-life (t½) of IMGN779 [ Time Frame: Up to 12 months ]
  • Immunogenicity: Presence of Antibody-Drug Antibody (ADA) [ Time Frame: Up to 12 months ]

Estimated Enrollment: 124
Study Start Date: March 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Escalation Schedule A
IMGN779 administered on days 1 and 15 of a 28-day cycle
Drug: IMGN779
Experimental: Dose Escalation Schedule B
IMGN779 administered on days 1, 8, 15 and 22 of a 28-day cycle
Drug: IMGN779
Experimental: Dose Expansion Cohort 1
Patients with AML at first relapse occurring within12 months; IMGN779 administered at dose and schedule selected.
Drug: IMGN779
Experimental: Dose Expansion Cohort 2
Patients with Relapse Refractory AML; IMGN779 administered at dose and schedule selected.
Drug: IMGN779

Detailed Description:
In the Dose Escalation Phase, patients will be assigned to one of two schedules. The MTD for both schedules will be determined from the assessment of Dose Limiting Toxicities (DLTs). The Dose Expansion Phase will consist of two cohorts based on patients response to prior therapy according to the MTD selected.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dose Escalation: Patients with relapsed or refractory AML
  • Dose Expansion Cohort 1: Patients with relapsed AML or patients who refuse, or ar not suitable candidates for induction therapy
  • Dose Expansion Cohort 2: Patients with refractory AML

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674763


Contacts
Contact: ImmunoGen Clinical Operations 781-895-0600 IMGN0601@immunogen.com

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Memorial Sloan Kettering, Cancer Center Not yet recruiting
New York City, New York, United States, 10471
United States, Oregon
Knight Cancer Institute - OSHU Recruiting
Portland, Oregon, United States, 97239
United States, Texas
The University of Texas, MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
ImmunoGen, Inc.
Investigators
Study Director: Anna Berkenblit, MD ImmunoGen, Inc.
  More Information

Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT02674763     History of Changes
Other Study ID Numbers: IMGN779 0601
First Submitted: February 1, 2016
First Posted: February 4, 2016
Last Update Posted: September 26, 2016
Last Verified: September 2016

Keywords provided by ImmunoGen, Inc.:
Acute Myeloid Leukemia
AML
IMGN779
ImmunoGen
Phase 1
Relapsed
Refractory
CD33
Dose Escalation
Dose Expansion

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms