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NCT01896999 · ClinicalTrials.gov registry record · Phase 1
Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
A Phase 1 study of Recurrent Classic Hodgkin Lymphoma and Refractory Classic Hodgkin Lymphoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 146
- Enrollment target
- 20
- Study locations
NCT01896999: Active Phase 1 study of Recurrent Classic Hodgkin Lymphoma and Refractory Classic Hodgkin Lymphoma, sponsored by National Cancer Institute (NCI).
NCT01896999 is a Phase 1 study of Recurrent Classic Hodgkin Lymphoma and Refractory Classic Hodgkin Lymphoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 146 participants, above the 44-participant average among 3 other Recurrent Classic Hodgkin Lymphoma trials with a reported enrollment target (232% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01896999, a Phase 1 study of Recurrent Classic Hodgkin Lymphoma and Refractory Classic Hodgkin Lymphoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 146 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase I/II trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin, and how well they work in treating patients with Hodgkin lymphoma that has returned after a period of improvement (recurrent) or has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. 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. It is not known whether giving brentuximab vedotin and nivolumab with or without ipilimumab may kill more cancer cells.
Primary Outcome
MTD defined as the highest dose level at which less than 33% of 6 patients experience a dose limiting toxicity, will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Upon completion of the trial, frequency of subjects experiencing toxicities will be tabulated. Toxicities will be assessed and graded according to CTCAE version 4.0 terminology. Exact 95% confidence intervals (CI) around the toxicity proportions will be calculated.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- DRUG Brentuximab Vedotin
- BIOLOGICAL Ipilimumab
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Kaiser Permanente Dublin - Dublin
Alabama
- Children's Hospital of Alabama - Birmingham
- University of Alabama at Birmingham Cancer Center - Birmingham
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2014-03-07 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT01896999 still lists
NCT01896999 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, above the 44-participant average among 3 other Recurrent Classic Hodgkin Lymphoma trials with a reported enrollment target (232% higher).
The record links to 2 conditions, with Recurrent Classic Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT01896999 names 20 study sites across 5 states, led by Alaska, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT01896999 about?
NCT01896999 is a clinical study titled "Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma". This phase I/II trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin, and how well they work in treating patients with Hodgkin lymphoma that has returned after a period of improvement (recurrent) or has not responded to previous treatm...
What is the current status of trial NCT01896999?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 146 participants. The study started on 2014-03-07. Estimated completion is 2026-12-31.
What conditions does trial NCT01896999 study?
This clinical trial studies the following conditions: Recurrent Classic Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma.
What interventions are being tested in trial NCT01896999?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Brentuximab Vedotin (DRUG), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01896999?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01896999 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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