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NCT05039073 · ClinicalTrials.gov registry record · Phase 2
Brentuximab Vedotin and Nivolumab for the Treatment of Relapsed/Refractory Classic Hodgkin Lymphoma Previously Treated With Brentuximab Vedotin or Checkpoint Inhibitors
A Phase 2 study of Recurrent Classic Hodgkin Lymphoma and Refractory Classic Hodgkin Lymphoma, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 2
- Study locations
NCT05039073: Recruiting Phase 2 study of Recurrent Classic Hodgkin Lymphoma and Refractory Classic Hodgkin Lymphoma, sponsored by Emory University.
NCT05039073 is a Phase 2 study of Recurrent Classic Hodgkin Lymphoma and Refractory Classic Hodgkin Lymphoma that is actively recruiting participants, run by Emory University. The registered enrollment target is 46 participants, below the 77-participant average among 3 other Recurrent Classic Hodgkin Lymphoma trials with a reported enrollment target (40% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05039073, a Phase 2 study of Recurrent Classic Hodgkin Lymphoma and Refractory Classic Hodgkin Lymphoma, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial studies the effect of brentuximab vedotin and nivolumab in treating patients with classic Hodgkin lymphoma that has come back (relapsed) or does not respond to treatment (refractory) that have been previously treated with brentuximab vedotin or checkpoint inhibitors. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving brentuximab vedotin and nivolumab in combination may be an effective treatment in patients with relapsed or refractory classic Hodgkin lymphoma previously treated with brentuximab vedotin or checkpoint inhibitors.
Primary Outcome
Will be calculated and a 95% confidence interval will be estimated using the Clopper-Pearson method. Assessed per Lugano 2014 Criteria at any time point while on study therapy. Will be analyzed independently for each cohort (A and B).
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- BIOLOGICAL Nivolumab
- DRUG Brentuximab Vedotin
- PROCEDURE Hematopoietic Cell Transplantation
Study Locations (2)
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2022-05-02 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 2 |
What NCT05039073 shows while recruiting
NCT05039073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 77-participant average among 3 other Recurrent Classic Hodgkin Lymphoma trials with a reported enrollment target (40% lower).
The record links to 2 conditions, with Recurrent Classic Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT05039073 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05039073 about?
NCT05039073 is a clinical study titled "Brentuximab Vedotin and Nivolumab for the Treatment of Relapsed/Refractory Classic Hodgkin Lymphoma Previously Treated With Brentuximab Vedotin or Checkpoint Inhibitors". This phase II trial studies the effect of brentuximab vedotin and nivolumab in treating patients with classic Hodgkin lymphoma that has come back (relapsed) or does not respond to treatment (refractory) that have been previously treated with brentuximab vedotin or checkpoint inhibitors. Brentuximab ...
What is the current status of trial NCT05039073?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2022-05-02. Estimated completion is 2027-11-30.
What conditions does trial NCT05039073 study?
This clinical trial studies the following conditions: Recurrent Classic Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma.
What interventions are being tested in trial NCT05039073?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Nivolumab (BIOLOGICAL), Brentuximab Vedotin (DRUG), Hematopoietic Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT05039073?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05039073 being conducted?
This trial has 2 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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