Clinical Trials in Spain / NCT03386513
Active, not recruiting
Phase 1/2
Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN
NCT03386513 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Blastic Plasmacytoid Dendritic Cell NeoplasmMyeloproliferative Neoplasm
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.
Eligibility
Inclusion Criteria:
1. 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.
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:
1. Participants who, in the judgment of their treating physician, have appropriate standard of care therapies will be excluded from Cohorts 1 through 5.
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.
Primary outcome measure(s)
- Composite Complete Remission/Response (CCR) Rate As Assessed by Investigator in Frontline De Novo Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Participants — Up to approximately 81 months
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.
Trial sites (29)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | |
| Banner Health MD Anderson Cancer Center | Gilbert | Arizona | |
| City of Hope Medical Center | Duarte | California | |
| UCLA | Los Angeles | California | |
| Stanford | Stanford | California | |
| Moffitt Cancer Center | Tampa | Florida | |
| University of Maryland Medical Center | Baltimore | Maryland | |
| Dana-Farber Cancer Institute | Boston | Massachusetts | |
| Roswell Park Cancer Institute | Buffalo | New York | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| Novant Health Cancer Institute Hematology | Charlotte | North Carolina | |
| Duke Cancer Institute | Durham | North Carolina | |
| Novant Health Cancer Institute Hematology - Forsyth | Winston-Salem | North Carolina | |
| Baylor Scott & White University Medical Center | Dallas | Texas | |
| MD Anderson Cancer Center | Houston | Texas | |
| Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance | Seattle | Washington | |
| 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 |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03386513 on ClinicalTrials.gov ↗ ← All trials in Spain