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NCT04216524 · ClinicalTrials.gov registry record · Phase 2
Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm
A Phase 2 study of Blastic Plasmacytoid Dendritic Cell Neoplasm, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04216524: Recruiting Phase 2 study of Blastic Plasmacytoid Dendritic Cell Neoplasm, sponsored by M.D. Anderson Cancer Center.
NCT04216524 is a Phase 2 study of Blastic Plasmacytoid Dendritic Cell Neoplasm that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 40 participants, below the 89-participant average among 6 other Blastic Plasmacytoid Dendritic Cell Neoplasm trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04216524, a Phase 2 study of Blastic Plasmacytoid Dendritic Cell Neoplasm, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The median PFS time will be estimated by Bayesian posterior estimates. Estimated using the Kaplan-Meier method.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Dexamethasone
- DRUG Cytarabine
- DRUG Mercaptopurine
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-05-29 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT04216524 shows while recruiting
NCT04216524 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 89-participant average among 6 other Blastic Plasmacytoid Dendritic Cell Neoplasm trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Blastic Plasmacytoid Dendritic Cell Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04216524 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04216524 about?
NCT04216524 is a clinical study titled "Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm". 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 ...
What is the current status of trial NCT04216524?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2020-05-29. Estimated completion is 2026-12-31.
What conditions does trial NCT04216524 study?
This clinical trial studies the following conditions: Blastic Plasmacytoid Dendritic Cell Neoplasm.
What interventions are being tested in trial NCT04216524?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Dexamethasone (DRUG), Cytarabine (DRUG), Mercaptopurine (DRUG).
Who is sponsoring clinical trial NCT04216524?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04216524 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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