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NCT02055820 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax Combined With Chemotherapy in Participants With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 267
- Enrollment target
NCT02055820: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT02055820 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 267 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (345% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02055820, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 267 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, dose-finding study of venetoclax administered orally in combination with rituximab (R) or obinutuzumab (G) and standard doses of cyclophosphamide, doxorubicin, vincristine and oral prednisone (CHOP) in participants with Non-Hodgkin's Lymphoma (NHL). The study consisted of 2 stages: a dose-finding Phase Ib stage and a Phase II expansion stage. In the Phase I portion of the study, participants were randomized to one of 2 treatment arms venetoclax in combination with R-CHOP (Arm A) and venetoclax in combination with G-CHOP (Arm B) and explored the doses of venetoclax in combination with R-CHOP and G-CHOP. The maximum tolerated dose (MTD) of venetoclax in combination with R-CHOP and G-CHOP was determined during the dose-finding stage. For the Phase II portion of the study, the venetoclax dose for venetoclax + R-CHOP was on a non-continuous dosing schedule as determined by the Phase Ib portion of the study based on safety and tolerability observed in participants treated in the dose escalation portion of the study. On 17 July 2016, Roche/Genentech as the sponsor of Study BO21005 (Goya study), a Phase III study that evaluated G CHOP versus R-CHOP in 1L DLBCL, informed through a press release that the primary endpoint of investigator-assessed PFS was not met. Given these results, Arm B (venetoclax + G-CHOP) was not expanded in Phase II in patients who are first-line with DLBCL.
Primary Outcome
DLTs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0). Decrease in B cells, lymphopenia, and leukopenia caused by lymphopenia were not considered DLTs but instead were expected outcomes of study treatment. Any Grade \>/= 3 adverse event, that was attributed to having a reasonable possibility of being related to the combined administration of venetoclax plus R-CHOP or G-CHOP, that could not be attributed by the i
Interventions
- DRUG Obinutuzumab
- DRUG Venetoclax
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Rituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2013-11-17 |
| Est. Completion | 2019-06-28 |
| Phase | Phase 1 |
What the finished NCT02055820 record still lists
NCT02055820 is an interventional study that assigns participants to a tested intervention. The registered 267 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (345% higher).
The record links to 0 conditions, and to 5 interventions - of which Obinutuzumab is the first listed.
NCT02055820 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02055820 about?
NCT02055820 is a clinical study titled "A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax Combined With Chemotherapy in Participants With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL". This is a multicenter, open-label, dose-finding study of venetoclax administered orally in combination with rituximab (R) or obinutuzumab (G) and standard doses of cyclophosphamide, doxorubicin, vincristine and oral prednisone (CHOP) in participants with Non-Hodgkin's Lymphoma (NHL). The study consi...
What is the current status of trial NCT02055820?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 267 participants. The study started on 2013-11-17. Estimated completion is 2019-06-28.
What interventions are being tested in trial NCT02055820?
The interventions under investigation include: Obinutuzumab (DRUG), Venetoclax (DRUG), Cyclophosphamide (DRUG), Doxorubicin (DRUG), Rituximab (DRUG).
Who is sponsoring clinical trial NCT02055820?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02055820's enrollment target sits among peer trials
267 154th of 2000 higher than 1,847 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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