Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Part of paid clinical trials in Rochester, Minnesota.
- Sponsor
- Mayo Clinic
- Study ID
- NCT03075553
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Blastic Plasmacytoid Dendritic Cell Neoplasm
- HTLV-1 Infection
- Hepatosplenic T-Cell Lymphoma
- NK-Cell Lymphoma, Unclassifiable
- Primary Systemic Anaplastic Large Cell Lymphoma, ALK-Negative
- Recurrent Adult T-Cell Leukemia/Lymphoma
- Recurrent Anaplastic Large Cell Lymphoma
- Recurrent Angioimmunoblastic T-cell Lymphoma
- Recurrent Enteropathy-Associated T-Cell Lymphoma
- Recurrent Mycosis Fungoides
- Refractory Adult T-Cell Leukemia/Lymphoma
- Refractory Anaplastic Large Cell Lymphoma
- Refractory Angioimmunoblastic T-cell Lymphoma
- Refractory Enteropathy-Associated T-Cell Lymphoma
- Refractory Mycosis Fungoides
- Refractory Nasal Type Extranodal NK/T-Cell Lymphoma
- Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Laboratory Biomarker Analysis — OTHERCorrelative studies
- Nivolumab — BIOLOGICALGiven IV
Study Details
This phase II trial studies how well nivolumab works in treating patients with peripheral T-cell lymphoma that has come back after a period of improvement or that does not respond to treatment. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells.
Key Dates
- Start date
- May 17, 2017
- Status verified
- May 2019
- Primary completion
- May 29, 2019
- Completion
- May 29, 2019
Study Design
- Enrollment
- 12 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (nivolumab)Patients receive nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive nivolumab IV over 60 minutes on day 1 of course 9. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Response Rate for Participants Who Achieve a CR or PR [CT-based Response] [ Time Frame: Up to 390 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | - |
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