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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: Active Phase 1 study of Non-Hodgkin Lymphoma, sponsored by Case Comprehensive Cancer Center.
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 168-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (85% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety of intervention will be measured by the effect on hematologic engraftment (engraftment Dose Limiting Toxicity DLT). This includes failure of absolute neutrophil count (ANC) engraftment OR platelet engraftment. • Failure of ANC engraftment which is defined as failure to engraft by day 15. OR • Failure of platelet engraftment which is defined as failure to engraft by day 30.
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 |
What the registry record for NCT03713580 still lists
NCT03713580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 168-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (85% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03713580's enrollment target sits among peer trials
25 78th of 106 higher than 27 of 106 other Non-Hodgkin Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Hodgkin Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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