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

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ClinicalTrials.gov Identifier: NCT02674763
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.

Tracking Information
First Submitted Date  ICMJE February 1, 2016
First Posted Date  ICMJE February 4, 2016
Last Update Posted Date September 4, 2019
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
Maximum Tolerated Dose (MTD) of IMGN779 [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-label Study of IMGN779 in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia
Official Title  ICMJE A Phase 1, Multi-center, Open-label Study of IMGN779 Administered Intravenously in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE Drug: IMGN779
Study Arms  ICMJE
  • Experimental: Dose Escalation Schedule A
    IMGN779 administered on days 1 and 15 of a 28-day cycle
    Intervention: Drug: IMGN779
  • Experimental: Dose Escalation Schedule B
    IMGN779 administered on days 1, 8, 15 and 22 of a 28-day cycle
    Intervention: Drug: IMGN779
  • Experimental: Dose Escalation Schedule C
    IMGN779 administered on days 1 and 8 of a 21-day cycle
    Intervention: Drug: IMGN779
  • Experimental: Dose Expansion Cohort
    Patients with Relapsed AML; IMGN779 administered at dose and schedule selected as the putative RP2D.
    Intervention: Drug: IMGN779
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2019)
62
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2016)
124
Actual Study Completion Date  ICMJE July 2019
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02674763
Other Study ID Numbers  ICMJE IMGN779 0601
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ImmunoGen, Inc.
Study Sponsor  ICMJE ImmunoGen, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Patrick Zweidler-McKay, MD ImmunoGen, Inc.
PRS Account ImmunoGen, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP