Study on IMGN632 for Patients with Untreated and Relapsed Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Sponsor: AbbVie
ClinicalTrials ID:NCT03386513
This clinical trial is testing a new drug, IMGN632, to see if it is safe and effective for patients with BPDCN, a type of blood cancer. The study includes patients who have not been treated before and those whose cancer has returned or did not respond to previous treatments.
Patient Parameters
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Program Overview
This study is exploring the safety and effectiveness of a new drug called IMGN632 for treating patients with a type of blood cancer known as Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). The trial is open to patients who have not received treatment before, as well as those whose cancer has come back or did not respond to previous treatments. IMGN632 is given through an IV on the first day of each 21-day cycle.
Description
IMGN632 is a new treatment being tested for its ability to fight a type of blood cancer called BPDCN. The drug is given through an IV on the first day of each treatment cycle, which repeats every 21 days. The study aims to find the best dose and to see how well the drug works on its own. Researchers will also look at how the body processes the drug and whether it causes any immune reactions.
Eligibility Criteria
Inclusion Criteria
- Must have a type of cancer that shows a marker called CD123.
- Open to patients with different types of blood cancers, including:
- BPDCN that has returned or not responded to 1-3 previous treatments.
- Acute Myeloid Leukemia (AML) that has returned.
- Acute Lymphoblastic Leukemia (ALL) that has returned, including various subtypes.
- Other blood cancers not listed above, such as high-risk Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML).
- Newly diagnosed BPDCN patients who have not had systemic treatment before.
- Patients in the newly diagnosed group may have had local treatments like radiation or surgery but must have cancer that has come back or spread beyond the treated area.
Exclusion Criteria
- Patients who have other standard treatment options available will not be included in some groups.
- Newly diagnosed BPDCN patients with cancer in the brain or spinal cord are not eligible.
- Patients with a history of certain severe liver or fluid-related conditions are not eligible.
- Patients must not have received any cancer treatment within 14 days before starting the study, except for those who had a checkpoint inhibitor, which must be stopped 28 days before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Banner Health MD Anderson Cancer Center | 85234 | Gilbert | Arizona |
| City of Hope Medical Center | 91010 | Duarte | California |
| UCLA | 90095 | Los Angeles | California |
| Stanford | 94305 | Stanford | California |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| University of Maryland Medical Center | 21201 | Baltimore | Maryland |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Roswell Park Cancer Institute | 14263 | Buffalo | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Novant Health Cancer Institute Hematology | 28204 | Charlotte | North Carolina |
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