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NCT03064867 · ClinicalTrials.gov registry record · Phase 1
Venetoclax Plus R-ICE Chemotherapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
A Phase 1 study of Diffuse Large B Cell Lymphoma, sponsored by Molly Gallogly.
- Active
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
- 3
- Study locations
NCT03064867: Active Phase 1 study of Diffuse Large B Cell Lymphoma, sponsored by Molly Gallogly.
NCT03064867 is a Phase 1 study of Diffuse Large B Cell Lymphoma that is active but no longer recruiting, run by Molly Gallogly. The registered enrollment target is 65 participants, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (70% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03064867, a Phase 1 study of Diffuse Large B Cell Lymphoma, is active but no longer recruiting, sponsored by Molly Gallogly.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
- 3
- 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 as a second treatment for relapsed/refractory DLBCL. In this study, venetoclax will be added to RICE (rituximab, ifosfamide, carboplatin, etoposide), a common set to cancer drugs used as a second line treatment for relapsed/refractory DLBCL. Venetoclax, is a new targeted anti-cancer drug, which works by mimicking a particular protein produced by the tumor and interrupting its normal processes, ultimately causing the tumor cells to die. Adding venetoclax to the standard RICE regimen is believed to increase the chance of getting cancer into remission. Venetoclax is experimental because it is not approved by the Food and Drug Administration (FDA) for the treatment of relapsed/refractory DLBCL. Venetoclax has been FDA approved for use in patients with chronic lymphocytic leukemia (CLL).
Primary Outcome
A maximum of 18 patients can theoretically participate in the initial dose escalation with Retinoic and Lithium, based on 4 dose levels with a maximum of 6 patients at each dose level. At a true dose limiting toxicity rate of 20%, the chance of escalating to the next dose level is 71% and of establishing the lower dose level as maximum tolerated dose is 29%.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Carboplatin
- DRUG Rituximab
- DRUG Etoposide
- DRUG Ifosfamide
Study Locations (3)
Ohio
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center - Cleveland
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center - Cleveland
Missouri
- Washington University School of Medicine, Siteman Cancer Center - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2017-06-26 |
| Est. Completion | 2023-08-12 |
| Phase | Phase 1 |
What the registry record for NCT03064867 still lists
NCT03064867 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Venetoclax is the first listed.
NCT03064867 reports a single indexed study location in Ohio, Missouri.
Frequently Asked Questions
What is clinical trial NCT03064867 about?
NCT03064867 is a clinical study titled "Venetoclax Plus R-ICE Chemotherapy for Relapsed/Refractory Diffuse Large B-Cell 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 as a second treatment for relapsed/refractory DLBCL. In this study, venetoclax will be added to RICE (rituximab, ifosfamide, carboplatin, eto...
What is the current status of trial NCT03064867?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2017-06-26. Estimated completion is 2023-08-12.
What conditions does trial NCT03064867 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma.
What interventions are being tested in trial NCT03064867?
The interventions under investigation include: Venetoclax (DRUG), Carboplatin (DRUG), Rituximab (DRUG), Etoposide (DRUG), Ifosfamide (DRUG).
Who is sponsoring clinical trial NCT03064867?
This trial is sponsored by Molly Gallogly, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03064867 being conducted?
This trial has 3 study locations across Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03064867's enrollment target sits among peer trials
65 50th of 114 higher than 65 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell 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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