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NCT03255096 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Safety, Pharmacokinetics, and Clinical Activity of Combination of RO6870810 and Venetoclax, With or Without Rituximab, in Participants With Relapsed/Refractory DLBCL and/or High-Grade B-Cell Lymphoma and/or High Grade B-Cell Lymphoma With MYC and/or BCL2 and/or BCL6
A Phase 1 study of Diffuse Large B Cell Lymphoma and High Grade B-Cell Lymphoma, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 9
- Study locations
NCT03255096: Completed Phase 1 study of Diffuse Large B Cell Lymphoma and High Grade B-Cell Lymphoma, sponsored by Hoffmann-La Roche.
NCT03255096 is a Phase 1 study of Diffuse Large B Cell Lymphoma and High Grade B-Cell Lymphoma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 39 participants, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (82% lower). The trial reports 9 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03255096, a Phase 1 study of Diffuse Large B Cell Lymphoma and High Grade B-Cell Lymphoma, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 9
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, tolerability and clinical activity of RO6870810 in combination with venetoclax and when co-administered with rituximab in participants with relapse/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and/or high-grade B-cell lymphoma with myelocytomatosis oncogene (MYC) and/or B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) gene rearrangements (HGBL-DH/TH).
Primary Outcome
DLT is defined as any of the toxicities- occurs within the first cycle for which the participant receives the full intended combination doses and number of administrations; is considered to be related to study treatment by the investigator; is not attributed to disease progression or another clearly identifiable cause.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Rituximab
- DRUG RO6870810
Study Locations (9)
Other
- Rigshospitalet; Hæmatologisk Klinik - København Ø
- Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia - Barcelona
- Hospital Duran i Reynals; Servicio de Hematologia - Barcelona
- START Madrid-FJD, Hospital Fundacion Jimenez Diaz - Madrid
California
- City of Hope National Medical Center - Duarte
- Stanford Cancer Center - Stanford
New York
- Weill Cornell Medical College - New York
North Carolina
- Levine Cancer Institute - Blythe - Charlotte
Victoria
- Peter MacCallum Cancer Centre-East Melbourne - Melbourne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2017-08-28 |
| Est. Completion | 2019-07-03 |
| Phase | Phase 1 |
What the finished NCT03255096 record still lists
NCT03255096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 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 (82% lower).
The record links to 2 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT03255096 lists 9 locations in 5 states (Other, California, New York).
Frequently Asked Questions
What is clinical trial NCT03255096 about?
NCT03255096 is a clinical study titled "A Study to Evaluate Safety, Pharmacokinetics, and Clinical Activity of Combination of RO6870810 and Venetoclax, With or Without Rituximab, in Participants With Relapsed/Refractory DLBCL and/or High-Grade B-Cell Lymphoma and/or High Grade B-Cell Lymphoma With MYC and/or BCL2 and/or BCL6". The purpose of this study is to evaluate the safety, tolerability and clinical activity of RO6870810 in combination with venetoclax and when co-administered with rituximab in participants with relapse/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and/or high-grade B-cell lymphoma with myelo...
What is the current status of trial NCT03255096?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2017-08-28. Estimated completion is 2019-07-03.
What conditions does trial NCT03255096 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, High Grade B-Cell Lymphoma.
What interventions are being tested in trial NCT03255096?
The interventions under investigation include: Venetoclax (DRUG), Rituximab (DRUG), RO6870810 (DRUG).
Who is sponsoring clinical trial NCT03255096?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03255096 being conducted?
This trial has 9 study locations across California, New York, North Carolina, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03255096's enrollment target sits among peer trials
39 69th of 114 higher than 45 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
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