Venetoclax + Tagraxofusp-erzs + Chemotherapy for BPDCN
Trial Summary
What is the purpose of this trial?
This phase II trial studies how well venetoclax, SL-401, and chemotherapy works in treating patients with blastic plasmacytoid dendritic cell neoplasm. Venetoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. SL-401 is a recombinant protein consisting of IL-3 linked to a toxic agent called DT. IL-3 attaches to IL-3 receptors on tumor cells in a targeted way and delivers DT to kill them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax and SL-401 with chemotherapy may be an effective treatment for patients with blastic plasmacytoid dendritic cell neoplasm.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it allows for certain medications like ARA-C (cytarabine) or Hydroxyurea to be used before or during the study for specific conditions related to BPDCN.
What data supports the effectiveness of the drugs used in the Venetoclax + Tagraxofusp-erzs + Chemotherapy for BPDCN trial?
The hyper-CVAD regimen, which includes cyclophosphamide, vincristine, doxorubicin, and dexamethasone, has shown significant activity in treating adult acute lymphocytic leukemia and other blood cancers. Additionally, the CyclOBEAP regimen, which includes cyclophosphamide, doxorubicin, vincristine, and prednisone, achieved a high complete response rate in patients with aggressive lymphoma, suggesting potential effectiveness of these drugs in similar blood-related conditions.12345
Is the combination of Venetoclax, Tagraxofusp-erzs, and chemotherapy generally safe for humans?
The safety of doxorubicin, a component of the chemotherapy regimen, has been studied in combination with other drugs, showing that it can be well-tolerated when administered properly. However, some studies have noted potential risks, such as cardiotoxicity (heart damage) and secondary cancers, when used with certain drugs like dexrazoxane. Overall, while these drugs have been used safely in various treatments, they can have significant side effects that need careful management.678910
What makes the drug combination of Venetoclax, Tagraxofusp-erzs, and Chemotherapy unique for BPDCN?
This drug combination is unique because it includes Venetoclax, which targets a specific protein (BCL-2) that helps cancer cells survive, and Tagraxofusp-erzs, which is a targeted therapy specifically designed for BPDCN (a rare type of blood cancer). This combination aims to enhance the effectiveness of traditional chemotherapy by using these targeted approaches.1011121314
Research Team
Naveen Pemmaraju, MD
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with a confirmed diagnosis of blastic plasmacytoid dendritic cell neoplasm. Participants should be in relatively good health (ECOG status 0-2), have normal heart function, and agree to use effective contraception. People who've had major surgery or certain treatments recently, are pregnant or breastfeeding, have active hepatitis B/C or HIV, severe heart issues, malabsorption syndrome, untreated brain/spinal cord problems, or prior venetoclax treatment can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction
Patients receive tagraxofusp-erzs (SL-401) and venetoclax with chemotherapy over multiple cycles
Maintenance
Patients receive venetoclax and POMP chemotherapy over 24 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cyclophosphamide
- Cytarabine
- Dexamethasone
- Doxorubicin
- Mercaptopurine
- Methotrexate
- Methylprednisolone
- Prednisone
- Rituximab
- Tagraxofusp-erzs
- Venetoclax
- Vincristine
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator