IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia

Part of paid clinical trials in Duarte, California.

Sponsor
AbbVie
Study ID
NCT04086264
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine — DRUG
    Commercially available formulation given subcutaneously (SC) or intravenous (IV)
  • IMGN632 — DRUG
    Study formulation given intravenously (IV)
  • Venetoclax — DRUG
    Commercially available formulation administered orally

Study Details

This is an open-label, multicenter, Phase 1b/2 study to determine the safety and tolerability of IMGN632 and assess the antileukemia activity of IMGN632 when administered in combination with azacitidine and/or venetoclax in participants with relapsed and frontline CD123-positive AML.

Key Dates

Start date
Nov 6, 2019
Status verified
Aug 2025
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
218 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen A (Closed to Enrollment)
    IMGN632, administered intravenously on Day 7 of a 28 day cycle at 0.015 mg/kg, 0.045 mg/kg, or 0.09 mg/kg, in combination with azacitidine, administered subcutaneously or intravenously daily at 75 mg/m2 on Days 1 to 7 of a 28 day cycle. Cycle 1 azacitidine dose in subsequent cohorts may be reduced.
  • Experimental: Regimen B (Closed to Enrollment)
    IMGN632, administered intravenously on Day 7 of a 21 day cycle at 0.015 mg/kg, 0.045 mg/kg, or 0.09 mg/kg, in combination with venetoclax, administered orally daily at 100 mg on Day 1, 200mg on Day 2, and 400 mg on the day 3 up to Day 21 of a 21 day cycle. Alternate schedules with reduced venetoclax administration may be explored.
  • Experimental: Regimen C-Frontline&Relapsed/Refractory(Closed to Enrollment)
    IMGN632, administered intravenously on Day 7 of a 28 day cycle at 0.015 mg/kg or 0.045 mg/ kg, in combination with azacitidine, administered subcutaneously or intravenously daily at 35-75 mg/ m2 given for Days 1 to 7 of a 28 day cycle and venetoclax, administered orally daily at 100 mg on Day 1, 200mg on Day 2, and 400 mg on Day 3 up to Day 28 of a 28 day cycle. Alternate schedules with reduced venetoclax administration or reduced azacitidine dose or administration may be explored.
  • Experimental: Regimen D (Closed to Enrollment)
    IMGN632, administered intravenously on Day 1 of a 21 day cycle at 0.045 mg/kg, as a monotherapy for Fit and Unfit MRD+ patients.

Primary Outcome Measure

Safety and Tolerability [ Time Frame: approximately 3 years ]

Locations (13)

FacilityCityStateZIPSite coordinators
City of Hope National Medical Center /ID# 269273DuarteCalifornia91010-
University Of California Irvine Medical Center /ID# 269275OrangeCalifornia92868-
Moffitt Cancer Center /ID# 269269TampaFlorida33612-
Northwestern University- Robert H. Lurie Comprehensive Cancer Center /ID# 269642ChicagoIllinois60611-3015-
Dana-Farber Cancer Institute /ID# 269267BostonMassachusetts02215-
University of Michigan /ID# 269079Ann ArborMichigan48109-2800-
Mayo Clinic Hospital Rochester /ID# 269643RochesterMinnesota55905-
Roswell Park Cancer Institute /ID# 269266BuffaloNew York14263-
New York Presbyterian Hospital Weill Cornell Medical Center /ID# 269271New YorkNew York10461-
Duke University Health System /ID# 269268DurhamNorth Carolina27705-3976-
Cleveland Clinic - Cleveland /ID# 269272ClevelandOhio44195-
MD Anderson Houston /ID# 269265HoustonTexas77030-4000-
Fred Hutchinson Cancer Research Center /ID# 269270SeattleWashington98109-

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope National Medical Center· Duarte, CAUniversity Of California Irvine Medical Center· Orange, CAMoffitt Cancer Center· Tampa, FLNorthwestern University- Robert H. Lurie Comprehensive Cancer Center· Chicago, ILDana-Farber Cancer Institute· Boston, MAUniversity of Michigan· Ann Arbor, MI

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