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NCT02733042 · ClinicalTrials.gov registry record · Phase 1
A Study to Determine Dose, Safety, and Efficacy of Durvalumab as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic Leukemia
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 106
- Enrollment target
NCT02733042: Completed Phase 1 study, sponsored by Celgene.
NCT02733042 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 106 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02733042, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 106 participants
- Enrollment target
Study Summary
This study is designed to determine the recommended phase 2 dose (RP2D), and the safety, and efficacy of durvalumab as monotherapy and when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and rituximab at the RP2D in adults with lymphoma or chronic lymphocytic leukemia (CLL).
Primary Outcome
Dose limiting toxicities were evaluated during the DLT evaluation period for participants in the dose finding cohorts. The severity grading was determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. A DLT is defined as below: Hematologic DLT • Grade 4 neutropenia observed for greater than 5 days duration • Grade 3 neutropenia associated with fever (≥ 38.5 °C) of any duration • Grade 4 thrombocytopenia or Grade 3 thrombocytopenia
Interventions
- DRUG Rituximab
- DRUG Lenalidomide
- DRUG Ibrutinib
- DRUG Durvalumab
- DRUG Bendamustine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2016-05-11 |
| Est. Completion | 2022-08-21 |
| Phase | Phase 1 |
What the finished NCT02733042 record still lists
NCT02733042 is an interventional study that assigns participants to a tested intervention. The registered 106 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 (77% higher).
The record links to 0 conditions, and to 5 interventions - of which Rituximab is the first listed.
NCT02733042 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02733042 about?
NCT02733042 is a clinical study titled "A Study to Determine Dose, Safety, and Efficacy of Durvalumab as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic Leukemia". This study is designed to determine the recommended phase 2 dose (RP2D), and the safety, and efficacy of durvalumab as monotherapy and when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and rituximab at the RP2D in adults with lymphoma or chronic lymphocytic leukem...
What is the current status of trial NCT02733042?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2016-05-11. Estimated completion is 2022-08-21.
What interventions are being tested in trial NCT02733042?
The interventions under investigation include: Rituximab (DRUG), Lenalidomide (DRUG), Ibrutinib (DRUG), Durvalumab (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT02733042?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02733042's enrollment target sits among peer trials
106 531st of 2000 higher than 1,468 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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