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NCT03386513 · ClinicalTrials.gov registry record · Phase 1
Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN
A Phase 1 study of Myeloproliferative Neoplasm and Blastic Plasmacytoid Dendritic Cell Neoplasm, sponsored by AbbVie.
- Active
- Registry status
- Phase 1
- Development phase
- 179
- Enrollment target
- 20
- Study locations
NCT03386513: Active Phase 1 study of Myeloproliferative Neoplasm and Blastic Plasmacytoid Dendritic Cell Neoplasm, sponsored by AbbVie.
NCT03386513 is a Phase 1 study of Myeloproliferative Neoplasm and Blastic Plasmacytoid Dendritic Cell Neoplasm that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 179 participants, above the 80-participant average among 40 other Myeloproliferative Neoplasm trials with a reported enrollment target (124% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03386513, a Phase 1 study of Myeloproliferative Neoplasm and Blastic Plasmacytoid Dendritic Cell Neoplasm, is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 179 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG IMGN632
Study Locations (20)
Other
- Recherche Clinique-Hématologie - Amiens
- CHU de Besancon, Hopital Jean Minjoz - Besançon
- Institut Paoli Calmettes (Marseille) - Marseille
- Hôpital St Antoine - Paris
- CHU Bordeaux Hôpital Haut-Lévêque - Pessac
California
- City of Hope Medical Center - Duarte
- UCLA - Los Angeles
- Stanford - Stanford
North Carolina
- Novant Health Cancer Institute Hematology - Charlotte
- Duke Cancer Institute - Durham
- Novant Health Cancer Institute Hematology - Forsyth - Winston-Salem
New York
- Roswell Park Cancer Institute - Buffalo
- Memorial Sloan Kettering Cancer Center - New York
Texas
- Baylor Scott & White University Medical Center - Dallas
- MD Anderson Cancer Center - Houston
Arizona
- Banner Health MD Anderson Cancer Center - Gilbert
Florida
- Moffitt Cancer Center - Tampa
Maryland
- University of Maryland Medical Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 179 participants |
| Start Date | 2018-01-02 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 1 |
What the registry record for NCT03386513 still lists
NCT03386513 is an interventional study that assigns participants to a tested intervention. The registered 179 participants enrollment target is mid-sized for trials with a published cap, above the 80-participant average among 40 other Myeloproliferative Neoplasm trials with a reported enrollment target (124% higher).
The record links to 2 conditions, with Myeloproliferative Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which IMGN632 is the first listed.
NCT03386513 names 20 study sites across 10 states, led by Other, California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT03386513 about?
NCT03386513 is a clinical study titled "Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN". 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.
What is the current status of trial NCT03386513?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 179 participants. The study started on 2018-01-02. Estimated completion is 2026-12-30.
What conditions does trial NCT03386513 study?
This clinical trial studies the following conditions: Myeloproliferative Neoplasm, Blastic Plasmacytoid Dendritic Cell Neoplasm.
What interventions are being tested in trial NCT03386513?
The interventions under investigation include: IMGN632 (DRUG).
Who is sponsoring clinical trial NCT03386513?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03386513 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03386513's enrollment target sits among peer trials
179 5th of 40 higher than 36 of 40 other Myeloproliferative Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myeloproliferative Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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