Back to resultsOpen-label Study of IMGN779 in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia
Primary Purpose
Acute Myeloid Leukemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IMGN779
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute Myeloid Leukemia, AML, IMGN779, ImmunoGen, Phase 1, Relapsed, Refractory, CD33, Dose Escalation, Dose Expansion
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
Sites / Locations
- Comprehensive Cancer Center (UAB CCC)
- Dana-Farber Cancer Institute
- New Mexico Cancer Care Alliance
- Roswell Park Cancer Institute
- Knight Cancer Institute - OSHU
- Baylor Scott & White University Medical Center
- The University of Texas, MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Dose Escalation Schedule A
Dose Escalation Schedule B
Dose Escalation Schedule C
Dose Expansion Cohort
Arm Description
IMGN779 administered on days 1 and 15 of a 28-day cycle
IMGN779 administered on days 1, 8, 15 and 22 of a 28-day cycle
IMGN779 administered on days 1 and 8 of a 21-day cycle
Patients with Relapsed AML; IMGN779 administered at dose and schedule selected as the putative RP2D.
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose (MTD) of IMGN779
Secondary Outcome Measures
Treatment emergent adverse events
Objective Response Rate (ORR) (complete response [CR= CR+CRp+CRi]+partial remission [PR])
PK parameters: maximum plasma concentration (Cmax) of IMGN779
PK parameters: area under the time-concentration curve (AUC) of IMGN779
PK parameters: terminal half-life (t½) of IMGN779
Immunogenicity: Presence of Antibody-Drug Antibody (ADA)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02674763
Brief Title
Open-label Study of IMGN779 in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
July 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmunoGen, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute Myeloid Leukemia, AML, IMGN779, ImmunoGen, Phase 1, Relapsed, Refractory, CD33, Dose Escalation, Dose Expansion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose Escalation Schedule A
Arm Type
Experimental
Arm Description
IMGN779 administered on days 1 and 15 of a 28-day cycle
Arm Title
Dose Escalation Schedule B
Arm Type
Experimental
Arm Description
IMGN779 administered on days 1, 8, 15 and 22 of a 28-day cycle
Arm Title
Dose Escalation Schedule C
Arm Type
Experimental
Arm Description
IMGN779 administered on days 1 and 8 of a 21-day cycle
Arm Title
Dose Expansion Cohort
Arm Type
Experimental
Arm Description
Patients with Relapsed AML; IMGN779 administered at dose and schedule selected as the putative RP2D.
Intervention Type
Drug
Intervention Name(s)
IMGN779
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) of IMGN779
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Treatment emergent adverse events
Time Frame
Up to 12 months
Title
Objective Response Rate (ORR) (complete response [CR= CR+CRp+CRi]+partial remission [PR])
Time Frame
Up to 12 months
Title
PK parameters: maximum plasma concentration (Cmax) of IMGN779
Time Frame
up to 12 months
Title
PK parameters: area under the time-concentration curve (AUC) of IMGN779
Time Frame
Up to 12 months
Title
PK parameters: terminal half-life (t½) of IMGN779
Time Frame
Up to 12 months
Title
Immunogenicity: Presence of Antibody-Drug Antibody (ADA)
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Zweidler-McKay, MD
Organizational Affiliation
ImmunoGen, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Comprehensive Cancer Center (UAB CCC)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
New Mexico Cancer Care Alliance
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Knight Cancer Institute - OSHU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Baylor Scott & White University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
The University of Texas, MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-label Study of IMGN779 in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia
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