What is BPDCN?
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare blood cancer. Each year, there are 1000 to 1400 newly diagnosed cases in the United States and Europe combined, and 3 out of 4 diagnosed patients are men.1 BPDCN often first appears as an unusual growth or change in appearance on the skin (also called a skin lesion), and may involve lymph nodes, blood, and bone marrow.
BPDCN IS AN AGGRESSIVE CANCER.
IF YOU OR SOMEONE YOU LOVE HAS BEEN DIAGNOSED, CONSIDER DISCUSSING CLINICAL TRIAL PARTICIPATION WITH YOUR DOCTOR.
IF YOU ARE A HEALTHCARE PROFESSIONAL WHO HAS A PATIENT WHO HAS BEEN DIAGNOSED WITH BPDCN, WHETHER OR NOT THEY HAVE RECEIVED PRIOR THERAPY, THEY MAY BE ELIGIBLE TO PARTICPATE IN A CLINICAL TRIAL STUDYING AN EXPERIMENTAL DRUG, IMGN632.
Why participate in a clinical trial?
Clinical trials are research studies. The goal of clinical trials is to find new ways to treat a disease or a condition. Your participation in this trial may help doctors learn more about your type of cancer and how to treat it. The information learned from clinical trials may be useful to future patients and researchers.
WHAT IS IMGN632?
IMGN632 is designed to target CD123-positive cancer cells while sparing normal cells from toxicity. IMGN632 is a type of drug called an antibody-drug conjugate (ADC). IMGN632 is an investigational drug not approved by the US Food and Drug Administration or any other health authority. The safety and efficacy of IMGN632 has not been determined.
CD123 is expressed at high levels in BPDCN, making it a potential target for treatment. IMGN632 is an investigational antibody-drug conjugate consisting of a CD123-directed antibody linked to a DNA alkylating agent.
A Phase 2 trial of IMGN632 is current enrolling; it includes patients with newly diagnosed BPDCN and patients with relapsed or refractory BPDCN.
IMGN632 was granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA) for treatment in BPDCN. This study is being performed in order to investigate safety and efficacy and to support a biologics license application for IMGN632 in this indication.
aIMGN632 is an investigational drug not approved by the US Food and Drug Administration or any other health authority. The safety and efficacy of IMGN632 has not been determined.
About the clinical Trial
This is an open-label, single arm, multi-center, phase 2 study to assess the safety and anti-BPDCN activity of IMGN632 when administered as monotherapy to patients with CD123+ disease.
KEY INCLUSION CRITERIA
- Patients 18 years and older
- Patients with newly diagnosed BPDCN who have not received prior systemic therapy. These patients may have had no therapy, or they may have received local therapy (radiotherapy, surgical excision, photodynamic therapy, OR
- Patients with relapsed or refractory BPDCN who have received 1 to 3 prior lines of therapy
- Every patient who participates in the trial will receive the study drug (IMGN632); there is no placebo in this study
- Patients will receive IMGN632 once every 3 weeks
- IMGN632 can be administered by your study doctor in either an outpatient setting or in the hospital (your doctor will let you know what is best for you)
- There are no additional costs to patients for participating in the study (beyond those associated with your usual care).
- Travel reimbursement may be available; the study costs are being paid for by ImmunoGen, Inc., the sponsor of the study
Why participate in a clinical trial?
Clinical trials are research studies. The goal of clinical trials is to find new ways to treat a disease or a condition. Your participation in this trial may help doctors learn more about your type of cancer and how to treat it. The information learned from clinical trials may be useful to future patients and researchers.
Please visit https://clinicaltrials.gov/ct2/show/NCT03386513 for more information about this clinical trial.
WHO MAY BE ELIGIBLE?
TO DISCUSS ELIGIBILITY FOR THE CLINICAL TRIAL, CONTACT YOUR NEAREST CENTER DIRECTLY, OR SPEAK WITH YOUR HEALTHCARE PROFESSIONAL.
STUDY LOCATIONS
Click or tap to show/hide contact information.
For more information, talk to your doctor, or contact one of these study locations about participating in the study, or contact ImmunoGen Medical Affairs at 781-895-0600 or medicalaffairs@immunogen.com.
CAUTION: NEW DRUG—LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE
References: 1. Leukemia & Lymphoma Society. Facts about blastic plasmacytoid dendritic cell neoplasm (BPDCN). Revised July 2019. Accessed March 22, 2021. https://www.lls.org/sites/default/files/National/USA/Pdf/Publications/FSHP2_BPDCN_FINAL_2019.pdf. 2. Laribi K, Denizon N, Besançon A, et al. Blastic plasmacytoid dendritic cell neoplasm: from origin of the cell to targeted therapies. Biol Blood Marrow Transplant. 2016;22(8):1357-1367. 3. Sullivan JM, Rizzieri DA. Treatment of blastic plasmacytoid dendritic cell neoplasm. Hematology Am Soc Hematol Educ Program. 2016(1);16-23. 4. Julia F, Petrella T, Beylot-Barry M, et al. Blastic plasmacytoid dendritic cell neoplasm: clinical features in 90 patients. Br J Dermatol. 2013;169(3):579-586. 5. Facchetti F, Cigognetti M, Fisogni S, et al. Neoplasms derived from plasmacytoid dendritic cells. Mod Pathol. 2016;29(2):98-111. 6. Pagano L, Giovanna Valentini C, Pulsoni A, et al. Blastic plasmacytoid dendritic cell neoplasm with leukemic presentation: an Italian multicenter study. Haematologica. 2013;98(2):239-246.