Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (NCT03075553) | Clinical Trial Compass
TerminatedPhase 2
Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Stopped: due to poor response
United States12 participantsStarted 2017-05-17
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Relapsed or refractory T-cell lymphoma (TCL) biopsy-proven =\< 6 months prior to registration, including the following subtypes:
* Peripheral T-cell lymphoma, not otherwise specified
* Anaplastic large cell lymphoma, anaplastic lymphoma kinase (ALK) negative, primary systemic type
* Angioimmunoblastic T-cell lymphoma
* Extranodal natural killer (NK)/T-cell lymphoma, nasal type
* Adult T-cell lymphoma/leukemia (human T-lymphotropic virus 1 \[HTLV1\]+)
* Blastic NK-cell lymphoma
* Enteropathy-associated T-cell lymphoma
* Hepatosplenic gamma delta T-cell lymphoma
* Transformed mycosis fungoides
* T/NK-cell lymphoma, unclassifiable
* Measurable disease: subjects must have at least one lesion that is \> 15mm (1.5 cm) in the longest diameter on cross-sectional imaging and measureable in two perpendicular dimensions per computed tomography (spiral CT) or magnetic resonance imaging (MRI)
* After failure of allogeneic stem cell transplant (ASCT) or after failure of frontline therapy in subjects who declined or are not ASCT candidates
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* White blood cell (WBC) \>= 3000/mm\^3
* Absolute neutrophil count (ANC) \>= 1500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Hemoglobin \> 9.0 g/dL
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) unless elevation due to Gilbert's Syndrome
* Aspartate transaminase (AST) =\< 2.5 x ULN
* Creatinine =\< 2.0 mg/dL
* Calculated crea…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Response Rate for Participants Who Achieve a CR or PR [CT-based Response]