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 — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given 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)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-

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