IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia (NCT04086264)

🧪 Interventions in This Study

• Azacitidine (DRUG)
• IMGN632 (DRUG)
• Venetoclax (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Patient must be ≥ 18 years of age.
2. Patients must have confirmed diagnosis of AML (excluding acute promyelocytic leukemia) based on World Health Organization classification (Arber 2016).
3. Disease characteristics and allowable prior therapy:
4. Patients must be evaluated for any available standard of care therapies (including induction, consolidation chemotherapy and/or transplant) and, in the opinion of the treating physician, be deemed appropriate for this experimental therapy.
5. Treatment-naïve (untreated) patients will be allowed in the Expansion Phase for Regimen C (Triplet) (IMGN632 + azacitidine + venetoclax). No prior treatments with hypomethylating agents (HMAs) for MDS are allowed.
6. Patients must have CD123-positive AML as confirmed by local flow cytometry (or immunohistochemistry \[IHC\]).
7. Patients may have received prior CD123-targeted therapies, except IMGN632, as long as CD123 remains detectable during screening.
8. Relapsed or refractory CD123-positive AML patients will be allowed to enroll in the Escalation Phase of Regimens A, B, and C (Triplet (IMGN632 + azacitidine, venetoclax, or azacitidine + venetoclax, respectively) and relapsed CD123-positive AML patients will be allowed to enroll the Expansion Phase of Regimens A-C. Note: Patients may also have received up to 2 prior lines of therapy, eg, frontline treatment (induction, consolidation \[including transplant\], and maintenance) and 1 salvage regimen.
9. Patients enrolling in Regimen D must be in CR (CR/CRh/CRp/ CRi) and be MRD+ at the time of screening, confirmed by central laboratory testing. Patients may have no more than 2 prior lines of therapy (which may include stem cell transplant), ie, frontline or first salvage. Note: Fit patients who received intensive treatment (eg 3+7, HiDAC) are eligible for Regimen D Cohort D1. Unfit patients who received non-intensive treatment (eg, HMA, low dose cytarabine) are eligible for Regimen D Cohort D2.
10. Previous treatment-related toxicities must have resolved to Grade 1 or baseline (excluding alopecia).
11. For patients enrolling in Regimens A-D, total WBC count must \< 25 × 10\^9 cells/L. Hydroxyurea may be used to control blood counts before Cycle 1 Day 1, at the discretion of the treating physician, according to institutional practice. During the Escalation Phase in Regimens A-C, hydroxyurea may also be used during Cycle 1.
12. Liver enzymes (AST and ALT) ≤ 3 × the upper limit of normal (ULN).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (29 Sites)

Showing the first 25 of 29 sites.

• City of Hope National Medical Center /ID# 269273 — Duarte, California
• University Of California Irvine Medical Center /ID# 269275 — Orange, California
• Moffitt Cancer Center /ID# 269269 — Tampa, Florida
• Northwestern University- Robert H. Lurie Comprehensive Cancer Center /ID# 269642 — Chicago, Illinois
• Dana-Farber Cancer Institute /ID# 269267 — Boston, Massachusetts
• University of Michigan /ID# 269079 — Ann Arbor, Michigan
• Mayo Clinic Hospital Rochester /ID# 269643 — Rochester, Minnesota
• Roswell Park Cancer Institute /ID# 269266 — Buffalo, New York
• New York Presbyterian Hospital Weill Cornell Medical Center /ID# 269271 — New York, New York
• Duke University Health System /ID# 269268 — Durham, North Carolina
• Cleveland Clinic - Cleveland /ID# 269272 — Cleveland, Ohio
• MD Anderson Houston /ID# 269265 — Houston, Texas
• Fred Hutchinson Cancer Research Center /ID# 269270 — Seattle, Washington
• Institut Paoli-Calmettes /ID# 269080 — Marseille, Bouches-du-Rhone
• IUCT Oncopole /ID# 269284 — Toulouse, Occitanie
• Hôpital Saint-Louis /ID# 269282 — Paris, Paris
• Centre Antoine-Lacassagne /ID# 269285 — Nice, Provence-Alpes-Côte d'Azur Region
• Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 269286 — Pierre-Bénite, Rhone
• Centre Hospitalier de Versailles André Mignot /ID# 269287 — Le Chesnay,
• Universitaetsklinikum Ulm /ID# 269686 — Ulm, Baden-Wurttemberg
• Universitaetsklinikum Muenster /ID# 269688 — Münster, North Rhine-Westphalia
• Universitaetsklinikum Leipzig /ID# 269682 — Leipzig, Saxony
• IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 269281 — Bologna, Bologna
• Istituto Europeo Di Oncologia /ID# 269646 — Milan, Milano
• Azienda Ospedaliero Universitaria Maggiore Della Carità /ID# 269280 — Novara, Novara

📞 Contact the Study Coordinator

Phone: (800) 826-4673

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.