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 range18 Years
SexALL
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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…
What they're measuring
1
Response Rate for Participants Who Achieve a CR or PR [CT-based Response]