Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN
NCT ID: NCT03386513
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
179 participants
INTERVENTIONAL
2018-01-02
2026-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Escalation and Expansion
Escalation: IMGN632 was administered by IV on 2 different schedules for participants with relapsed/refractory AML, ALL, or BPDCN.
Expansion: IMGN632 was administered by IV:
* Cohort 1: Relapsed or refractory BPDCN participants who have received 1-3 prior systemic therapies (incl. tagraxofusp-erzs and/or any other systemic therapy deemed appropriate for the treatment of BPDCN)
* Cohort 2: Relapsed AML
* Cohort 3: Relapsed or refractory ALL
* Cohort 4: Other relapsed or refractory hematologic malignancies
* Cohort 5: Relapsed or refractory AML at alternate dose or schedule
* Cohort 6: Pivotal cohort for frontline BPDCN participants who have not received prior systemic therapy and participants with frontline BPDCN who have prior or concomitant hematologic malignancy (PCHM) and have not received prior systemic therapy.
IMGN632
CD123-targeted ADC
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IMGN632
CD123-targeted ADC
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
a. Confirmation of CD123 positivity by flow cytometry or IHC. Participants who received prior CD123-targeting agents will be allowed as long as the blasts still have detectable CD123 expression.
2. Expansion inclusion:
* Cohort 1 - Participants with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN) with 1-3 prior lines of therapy
* Cohort 2 - Participants with relapsed AML
* Cohort 3 - Participants with relapsed relapsed or refractory ALL (including any subtypes: B-cell, T-cell, Ph+ and Ph-)
* Cohort 4 - Participants with relapsed or refractory other hematologic malignancies not included in the cohorts above (eg, high risk/very high-risk MDS, MPN, CMML, BP-CML).
* Cohort 5 - Participants with relapsed relapsed or refractory (to nonintense therapies) CD123+ AML.
* Cohort 6 - Participants with frontline de novo BPDCN at screening who have not received prior systemic therapy and participants with frontline BPDCN who have PCHM and have not received prior systemic therapy.
Note: Participants in Cohort 6 may have received local therapy (radiotherapy, surgical excision, photodynamic therapy). Eligible participants must have a recurrence or progression in the field of local therapy OR disease outside the field of local therapy.
Exclusion Criteria
2. Frontline BPDCN participants 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 participants 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.
3. Participants with a history of veno-occlusive disease (sinusoidal obstruction syndrome) of the liver.
4. Participants 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.
5. Interval from prior cancer therapy: 1. For frontline BPDCN participants with prior local therapy (eg, radiotherapy), participants must not have received treatment within 14 days prior to drug administration on this study. 2. Relapsed or refractory BPDCN participants 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. Participants must have recovered to baseline from all acute toxicity from this prior therapy.
Note: the exception that participants who have received a checkpoint inhibitor must not have received that therapy within 28 days prior to drug administration on this study.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Milan, , Italy
Azienda ospedaliera Santa Maria della Misericordia
Perugia, , Italy
Hospital Universitari I Politècnic La Fe
Valencia, , Spain
Churchill Hospital - Oxford
Oxford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Daver NG, Montesinos P, DeAngelo DJ, Wang ES, Papadantonakis N, Todisco E, Sweet KL, Pemmaraju N, Lane AA, Torres-Minana L, Thompson JE, Konopleva MY, Sloss CM, Watkins K, Bedse G, Du Y, Malcolm KE, Zweidler-McKay PA, Kantarjian HM. Pivekimab sunirine (IMGN632), a novel CD123-targeting antibody-drug conjugate, in relapsed or refractory acute myeloid leukaemia: a phase 1/2 study. Lancet Oncol. 2024 Mar;25(3):388-399. doi: 10.1016/S1470-2045(23)00674-5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-514195-40-00
Identifier Type: CTIS
Identifier Source: secondary_id
IMGN632-0801
Identifier Type: -
Identifier Source: org_study_id