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NCT04086264 · ClinicalTrials.gov registry record · Phase 1
IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia
A Phase 1 study of Acute Myeloid Leukemia, sponsored by AbbVie.
- Active
- Registry status
- Phase 1
- Development phase
- 218
- Enrollment target
- 20
- Study locations
NCT04086264: Active Phase 1 study of Acute Myeloid Leukemia, sponsored by AbbVie.
NCT04086264 is a Phase 1 study of Acute Myeloid Leukemia that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 218 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (90% higher). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04086264, a Phase 1 study of Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 218 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Evaluate the safety and tolerability and identify an RP2D of IMGN632 when administered in combination with azacitidine, with venetoclax, and with azacitidine and venetoclax in patients with relapsed or refractory CD123-positive AML through review of Treatment Emergent Adverse Events and abnormal laboratory values that result in a failure to meet the criteria for re-treatment.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG IMGN632
Study Locations (20)
California
- City of Hope National Medical Center /ID# 269273 - Duarte
- University Of California Irvine Medical Center /ID# 269275 - Orange
New York
- Roswell Park Cancer Institute /ID# 269266 - Buffalo
- New York Presbyterian Hospital Weill Cornell Medical Center /ID# 269271 - New York
Florida
- Moffitt Cancer Center /ID# 269269 - Tampa
Illinois
- Northwestern University- Robert H. Lurie Comprehensive Cancer Center /ID# 269642 - Chicago
Massachusetts
- Dana-Farber Cancer Institute /ID# 269267 - Boston
Michigan
- University of Michigan /ID# 269079 - Ann Arbor
Minnesota
- Mayo Clinic Hospital Rochester /ID# 269643 - Rochester
North Carolina
- Duke University Health System /ID# 269268 - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2019-11-06 |
| Est. Completion | 2027-02 |
| Phase | Phase 1 |
What the registry record for NCT04086264 still lists
NCT04086264 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (90% higher).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT04086264 names 20 study sites across 18 states, led by California, New York, Florida.
Frequently Asked Questions
What is clinical trial NCT04086264 about?
NCT04086264 is a clinical study titled "IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia". 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.
What is the current status of trial NCT04086264?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 218 participants. The study started on 2019-11-06. Estimated completion is 2027-02.
What conditions does trial NCT04086264 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT04086264?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), IMGN632 (DRUG).
Who is sponsoring clinical trial NCT04086264?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04086264 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04086264's enrollment target sits among peer trials
218 40th of 306 higher than 267 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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