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NCT03136497 · ClinicalTrials.gov registry record · Phase 1
A Study of ABT-199 Plus Ibrutinib and Rituximab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
A Phase 1 study, sponsored by Hackensack Meridian Health.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03136497: Clinical Trial Phase 1 study, sponsored by Hackensack Meridian Health.
NCT03136497 is a Phase 1 study that was terminated before completion, run by Hackensack Meridian Health. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03136497, a Phase 1 study, was terminated before completion, sponsored by Hackensack Meridian Health.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
A Study of Venetoclax Plus Ibrutinib and Rituximab in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL). Our hypothesis is that the combination therapy of BTK (Bruton's tyrosine kinase) Inhibitor Ibrutinib plus Venetoclax and Rituximab in relapsed or refractory DLBCL will have an increased activity with acceptable toxicity. Furthermore, this new novel therapeutic combination will be safe and well tolerated among this patient population.
Primary Outcome
Define maximum tolerated dose and /or recommended phase II dose for the combinations of venetoclax (ABT-199, GDC-0199) plus Ibrutinib (PCI-32765) and rituximab in Relapsed or Refractory DLBCL by assessing the incidence of dose limiting toxicities (DLTs).
Interventions
- DRUG Rituximab
- DRUG Ibrutinib
- DRUG 400mg ABT-199
- DRUG 800mg ABT-199
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-09-05 |
| Est. Completion | 2020-11-09 |
| Phase | Phase 1 |
Why NCT03136497 stopped before completion
NCT03136497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 4 interventions - of which Rituximab is the first listed.
NCT03136497 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03136497 about?
NCT03136497 is a clinical study titled "A Study of ABT-199 Plus Ibrutinib and Rituximab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma". A Study of Venetoclax Plus Ibrutinib and Rituximab in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL). Our hypothesis is that the combination therapy of BTK (Bruton's tyrosine kinase) Inhibitor Ibrutinib plus Venetoclax and Rituximab in relapsed or refractory DLBCL will have...
What is the current status of trial NCT03136497?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2017-09-05. Estimated completion is 2020-11-09.
What interventions are being tested in trial NCT03136497?
The interventions under investigation include: Rituximab (DRUG), Ibrutinib (DRUG), 400mg ABT-199 (DRUG), 800mg ABT-199 (DRUG).
Who is sponsoring clinical trial NCT03136497?
This trial is sponsored by Hackensack Meridian Health, which has 90 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03136497's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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