Acute Myeloid Leukemia Clinical Trial

Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN

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.

The study is enrolling a pivotal cohort of frontline BPDCN patients and a cohort of relapsed/refractory BPDCN patients.

View Full Description

Full Description

The study completed a dose escalation phase, and is now enrolling in a dose expansion phase to further characterize the safety profile and to assess the efficacy of IMGN632 in patients with BPDCN. IMGN632 is administered by IV on Day 1 of each cycle, with cycles repeating every 21 days.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Disease Characteristics:

a. Confirmation of CD123 positivity by flow cytometry or IHC. Patients who received prior CD123-targeting agents will be allowed as long as the blasts still have detectable CD123 expression.

Expansion inclusion:

Cohort 1 - Patients with relapsed or refractory BPDCN with 1-3 prior lines of therapy
Cohort 6 - Patients with frontline BPDCN who have not received prior systemic therapy.

Note: Patients in Cohort 6 may have received local therapy (radiotherapy, surgical excision, photodynamic therapy). Eligible patients must have a recurrence or progression in the field of local therapy OR disease outside the field of local therapy.

Exclusion Criteria:

Patients who, in the judgment of their treating physician, have appropriate standard of care therapies will be excluded from Cohorts 1 through 5.
Frontline BPDCN patients with central nervous system (CNS) disease will be excluded. A lumbar puncture must be performed during the 28-day screening period, prior to drug administration. Relapsed or refractory BPDCN patients with a known history of CNS disease must have been treated locally, have at least 1 lumbar puncture with no evidence of CNS disease, and must be clinically stable prior to first dose. Concurrent therapy for CNS prophylaxis or continuation of therapy for controlled CNS disease is permitted with the approval of the Sponsor.
Patients with a history of veno-occlusive disease of the liver.
Patients with a history of Grade 4 capillary leak syndrome, or non-cardiac Grade 4 edema are ineligible, eg, related to tagraxofusp-erzs or other etiology.
Interval from prior cancer therapy: 1. For frontline BPDCN patients with prior local therapy (eg, radiotherapy), patients must not have received treatment within 14 days prior to drug administration on this study. 2. Relapsed or refractory BPDCN patients must not have received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational agents within 14 days prior to drug administration on this study. Patients must have recovered to baseline from all acute toxicity from this prior therapy.

Note: the exception that patients who have received a checkpoint inhibitor must not have received that therapy within 28 days prior to drug administration on this study.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

252

Study ID:

NCT03386513

Recruitment Status:

Recruiting

Sponsor:

ImmunoGen, Inc.

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There are 21 Locations for this study

See Locations Near You

Banner Health MD Anderson Cancer Center
Gilbert Arizona, 85234, United States More Info
Michelle Lowe, BSN, RN, OCN
Contact
480-256-4739
[email protected]
Amy Tolenda
Contact
(480) 256-5439
[email protected]
Matthew Ulrickson, MD
Principal Investigator
City of Hope Medical Center
Duarte California, 91010, United States More Info
Ahmed Aribi, MD
Contact
626-218-1133
[email protected]
Contact
877-467-3411
Ahmed Aribi, MD
Principal Investigator
UCLA
Los Angeles California, 90095, United States More Info
Gary Schiller, MD
Contact
310-825-5513
[email protected]
Bruck Habtemariam
Contact
310-794-0242
[email protected]
Stanford
Stanford California, 94305, United States More Info
Woo In (Yustina) Cho
Contact
650-721-2443
[email protected]
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Caroline Wagstaff
Contact
813-745-5197
[email protected]
Kendra Sweet, MD
Principal Investigator
University of Maryland Medical Center
Baltimore Maryland, 21201, United States More Info
Vu Duong, MD
Contact
410-328-2567
[email protected]
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Daniel DeAngelo, MD
Contact
617-632-2645
[email protected]
Daniel DeAngelo, MD
Principal Investigator
Roswell Park Cancer Institute
Buffalo New York, 14263, United States More Info
Eunice Wang, MD
Contact
716-845-3544
[email protected]
Eunice Wang, MD
Principal Investigator
Novant Health Cancer Institute Hematology
Charlotte North Carolina, 28204, United States More Info
Kunal Shah
Contact
980-302-6297
[email protected]
Duke Cancer Institute
Durham North Carolina, 27710, United States
Novant Health Cancer Institute Hematology - Forsyth
Winston-Salem North Carolina, 27103, United States More Info
Paul Jordan
Contact
336-718-8553
[email protected]
Baylor Scott & White University Medical Center
Dallas Texas, 75246, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Naval Daver, MD
Contact
713-794-4392
[email protected]
Naveen Pemmaraju, MD
Contact
713-792-4956
[email protected]
Naval Daver, MD
Principal Investigator
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance
Seattle Washington, 98109, United States More Info
Kaysey Orlowski
Contact
206-667-1997
[email protected]
Roland Walter, MD
Principal Investigator
Recherche Clinique-Hématologie
Amiens , , France More Info
Delphine Lebon, MD
Contact
+33 3 22 45 59 14
[email protected]
CHU de Besancon, Hopital Jean Minjoz
Besançon , 25030, France More Info
Eric Deconinck, MD
Contact
+33381668232
[email protected]
Eric Deconinck, MD
Principal Investigator
Institut Paoli Calmettes (Marseille)
Marseille , 13009, France More Info
Valério Maisano, MD
Contact
04.91.22.37.54
[email protected]
Valério Maisano, MD
Principal Investigator
Hôpital St Antoine
Paris , , France More Info
Olliver Legrand, MD
Contact
+33 1 49 28 34 41
[email protected]
Alexis Genthon
Contact
+33 01 49 28 34 38
[email protected]
Olliver Legrand, MD
Principal Investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi
Bologna , 40138, Italy More Info
Antonio Curti, MD
Contact
+39 051 2143064
[email protected]
Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola , 47014, Italy More Info
Federica Frabetti
Contact
[email protected]
Giovanni Martinelli, MD
Contact
+39 0543 739480
[email protected]
Giovanni Martinelli, MD
Principal Investigator
Instituto Europeo di Oncologia
Milano , 20141, Italy More Info
Maria Chiara Massaro
Contact
+39 02 57489 403
[email protected]
Corrado Tarella, MD
Principal Investigator
Azienda ospedaliera Santa Maria della Misericordia
Perugia , 06132, Italy More Info
Maria Martelli, MD
Contact
+39 0755783603
[email protected]
Hospital Universitari I Politècnic La Fe
Valencia , 46026, Spain More Info
Pau Montsinos, MD
Contact
+34 96 1244925
[email protected]
David Bossis
Contact
+34 961 244 864
[email protected]
Pau Montesinos, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

252

Study ID:

NCT03386513

Recruitment Status:

Recruiting

Sponsor:


ImmunoGen, Inc.

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