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

September 3, 2019 updated by: ImmunoGen, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Escalation Schedule C
IMGN779 administered on days 1 and 8 of a 21-day cycle
Drug: IMGN779
Experimental: Dose Expansion Cohort
Patients with Relapsed AML; IMGN779 administered at dose and schedule selected as the putative RP2D.
Drug: IMGN779

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Tolerated Dose (MTD) of IMGN779
Time Frame: 28 days
28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImmunoGen, Inc.

Investigators

  • Study Director: Patrick Zweidler-McKay, MD, ImmunoGen, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

February 2, 2016

First Posted (Estimate)

February 4, 2016

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMGN779 0601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Myeloid Leukemia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe