Conditions

Blastic Plasmacytoid Dendritic Cell Neoplasm Myeloproliferative Neoplasm Acute Myeloid Leukemia and other blood cancers

Keywords

Antibody Drug ConjugateOther Hematologic MalignanciesMyeloproliferative NeoplasmsCD123MDSRelapsed, RefractoryAcute Lymphocytic LeukaemiaBlastic Plasmacytoid Dendritic Cell NeoplasmAcute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

Composite Complete Remission/Response (CCR) Rate As Assessed by Investigator in Frontline De Novo Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Participants
CCR rate was defined as percentage of participants with complete remission/response (CR) and clinical complete remission (CRc). CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/microliter \[μL\]) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on computed tomography (CT); and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Up to approximately 81 months

Secondary Outcomes (23)

Study Arms (1)

Escalation and Expansion

EXPERIMENTAL

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.

Drug: IMGN632

Interventions

IMGN632Drug

CD123-targeted ADC

Escalation and Expansion

PIVEKIMAB SUNIRINEType not reported

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Disease Characteristics:
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.

Sponsors & Collaborators

AbbVie
Industrylead
AbbVie Deutschland GmbH & Co. KG
Industrylead

Study Sites (29)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Banner Health MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

City of Hope Medical Center

Duarte, California, 91010, United States

UCLA

Los Angeles, California, 90095, United States

Stanford

Stanford, California, 94305, United States

Moffitt Cancer Center

Tampa, Florida, 33612, United States

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Related Publications (2)

Pemmaraju N, Marconi G, Montesinos P, Lane AA, Mazzarella L, Sallman DA, Ulrickson ML, Schiller GJ, Erba HP, Wang ES, Walter RB, Deconinck E, Aribi A, Legrand O, Lebon D, Maisano V, Martinelli G, DeAngelo DJ, Derenzini E, Du Y, Lakshmikanthan S, Potluri J, Kantarjian HM, Daver NG. Pivekimab Sunirine in Blastic Plasmacytoid Dendritic Cell Neoplasm. J Clin Oncol. 2026 Apr;44(10):861-873. doi: 10.1200/JCO-25-02083. Epub 2026 Feb 11.
PMID: 41671533DERIVED
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.
PMID: 38423051

MeSH Terms

Conditions

Blastic Plasmacytoid Dendritic Cell NeoplasmMyeloproliferative DisordersRecurrencePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Histiocytic Disorders, MalignantNeoplasms by Histologic TypeNeoplasmsLeukemiaLymphomaHematologic NeoplasmsNeoplasms by SiteSkin NeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Limitations and Caveats

For dose groups with n = 2, geometric mean and geometric %CV are reported but have very limited statistical reliability and should be interpreted with caution.

Results Point of Contact

Title: Global Medical Services
Organization: AbbVie

Study Officials

ABBVIE INC.
AbbVie
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (23)

Study Arms (1)

Escalation and Expansion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (29)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (23)

Study Arms (1)

Escalation and Expansion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (29)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Documents

Locations