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Brief Title: Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN
Official Title: A Phase 1/2, Multi-center, Open-label Study of IMGN632 Monotherapy Administered Intravenously in Patients With CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic Malignancies
Study ID: NCT03386513
Brief Summary: This is an open-label, multi-center, Phase 1/2 study to determine the MTD and assess the safety, tolerability, PK, immunogenicity, and anti-leukemia activity of IMGN632 when administered as monotherapy to patients with CD123+ disease.
Detailed Description: IMGN632 is administered by IV on Day 1 of each cycle, with cycles repeating every 21 days.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Banner Health MD Anderson Cancer Center, Gilbert, Arizona, United States
City of Hope Medical Center, Duarte, California, United States
UCLA, Los Angeles, California, United States
Stanford, Stanford, California, United States
Moffitt Cancer Center, Tampa, Florida, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Novant Health Cancer Institute Hematology, Charlotte, North Carolina, United States
Duke Cancer Institute, Durham, North Carolina, United States
Novant Health Cancer Institute Hematology - Forsyth, Winston-Salem, North Carolina, United States
Baylor Scott & White University Medical Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, Washington, United States
Recherche Clinique-Hématologie, Amiens, , France
CHU de Besancon, Hopital Jean Minjoz, Besançon, , France
Institut Paoli Calmettes (Marseille), Marseille, , France
Hôpital St Antoine, Paris, , France
CHU Bordeaux Hôpital Haut-Lévêque, Pessac, , France
University Hospital of Cologne, Cologne, , Germany
University Hospital of Leipzig, Leipzig, , Germany
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi, Bologna, , Italy
Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
Instituto Europeo di Oncologia, Milano, , Italy
Azienda ospedaliera Santa Maria della Misericordia, Perugia, , Italy
Hospital Universitari I Politècnic La Fe, Valencia, , Spain
Churchill Hospital - Oxford, Oxford, , United Kingdom
Name: Patrick Zweidler-McKay, MD
Affiliation: ImmunoGen, Inc.
Role: STUDY_DIRECTOR