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NCT03713580 · ClinicalTrials.gov registry record · Phase 1
Venetoclax in Combination With BEAM Conditioning Regimen for ASCT in Non-Hodgkin Lymphoma
A Phase 1 study of Non-Hodgkin Lymphoma, sponsored by Case Comprehensive Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 2
- Study locations
NCT03713580 is a Phase 1 study of Non-Hodgkin Lymphoma that is active but no longer recruiting, run by Case Comprehensive Cancer Center. The registered enrollment target is 25 participants, below the 151-participant average among 104 other Non-Hodgkin Lymphoma trials with a reported enrollment target (83% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT03713580, a Phase 1 study of Non-Hodgkin Lymphoma, is active but no longer recruiting, sponsored by Case Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to determine the correct dose and safety of adding a new cancer drug, Venetoclax, to a standard combination of chemotherapy drugs used prior to Autologous stem cell transplant (ASCT) in participants with Non-Hodgkin Lymphoma (NHL). In this study, Venetoclax will be added to BEAM (BCNU or carmustine, etoposide, cytarabine or ara-c, and melphalan). All NHL participants are admitted for conditioning chemotherapy which is given prior to the infusion of stem cells. Venetoclax is a new anti-cancer drug that works by targeting a protein (known as the Bcl-2 protein). By inhibiting or "blocking" this protein, a downstream cascade occurs which results in cancer cells to die. Adding Venetoclax to the standard BEAM conditioning chemotherapy with autologous stem cell transplant is believed to increase the chance of remission. Venetoclax is Food and Drug Administration (FDA) approved for participants with chronic lymphocytic leukemia (CLL). However, Venetoclax is investigational for this study because it is not yet approved for use in participants with NHL or in combination with BEAM chemotherapy.
Conditions Studied
Interventions
- DRUG Venetoclax
Study Locations (2)
Ohio
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center - Cleveland
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-03-12 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03713580
The ClinicalTrials.gov registry entry for NCT03713580 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 151-participant average among 104 other Non-Hodgkin Lymphoma trials with a reported enrollment target (83% lower). The listed sponsor is Case Comprehensive Cancer Center, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Venetoclax is the first listed.
NCT03713580 reports 2 study locations spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT03713580 about?
NCT03713580 is a clinical study titled "Venetoclax in Combination With BEAM Conditioning Regimen for ASCT in Non-Hodgkin Lymphoma". The purpose of this study is to determine the correct dose and safety of adding a new cancer drug, Venetoclax, to a standard combination of chemotherapy drugs used prior to Autologous stem cell transplant (ASCT) in participants with Non-Hodgkin Lymphoma (NHL). In this study, Venetoclax will be added...
What is the current status of trial NCT03713580?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2019-03-12. Estimated completion is 2025-12.
What conditions does trial NCT03713580 study?
This clinical trial studies the following conditions: Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT03713580?
The interventions under investigation include: Venetoclax (DRUG).
Who is sponsoring clinical trial NCT03713580?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03713580 being conducted?
This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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