About this trial
The purpose of this study is to understand and determine if ruxolitinib added to pembrolizumab is safe and effective for the treatment of relapsed or refractory Hodgkin and non-Hodgkin lymphomas.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Arm 1: PTCL
Nodal PTCL Peripheral T-cell Lymphoma- Not Otherwise Specified (PTCL-NOS)
Anaplastic Large Cell Lymphoma (ALCL) T-follicular Helper Lymphomas (TFH) and its subtypes including angioimmunoblastic T-cell Lymphoma (AITL)
Extranodal NK/T-cell lymphoma
Disqualifiers
1) Diagnosis of Adult T-Cell Leukemia/Lymphoma (ATLL)
2) History of autoimmune disease that requires systemic treatment.
3) Has a diagnosis of immunodeficiency or receiving immunosuppressive therapy within 7 days prior to the first dose of study drug.
4) Actively chronic systemic steroids therapy (in dosing exceeding 10mg daily of prednisone or its drug equivalent).
Trial design
Single group
Treatments tested in this trial
Ruxolitinib
DrugPatients will receive the study drug ruxolitinib for as long as the disease responds, for up to a maximum of one year (or 17 cycles). After study treatment with ruxolitinib is finished, the study doctor will continue to watch for side effects and follow the condition for one year. If any side effects are experienced, the study doctor will follow up until resolution or stabilization of the side effect.
Pembrolizumab
DrugPembrolizumab immunotherapy will be administered intravenously at 200 mg once every 21 days. Subjects will receive pembrolizumab for as long as the disease responds, up to a maximum of one year (or 17 cycles). Each cycle is 21 days long.
Treatment groups
Trial outcomes
Primary outcomes
Complete Response (CR) rate
For Arm 1, in patients with Peripheral T-cell Lymphoma (PTCL), the primary objective will be complete response (CR) rate.
Overall response rate (ORR)
For Arm 2, in patients with Cutaneous T-cell Lymphoma (CTCL), the primary objective will be overall response rate (ORR)
Sponsors and contacts
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