A Phase II Trial of JAK Inhibitor Added to Immunotherapy for Treatment of Relapsed/Refractory T-cell Lymphoma and 9p Amplified Lymphomas
Seda S. Tolu
Summary
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.
Description
This study includes peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphomas (CTCL), and other lymphomas (Hodgkin Lymphoma \[HL\], Gray Zone Lymphomas \[GZL\], and Primary Mediastinal B-cell Lymphoma \[PMBCL\]) that has become resistant to commonly available chemotherapy (refractory), or it has re-occurred after treatment (relapsed). For PTCL participants, the main goal is to see how many achieve complete remission (no signs of cancer). For CTCL participants, the focus is on the overall response rate, meaning how many show improvement. This study is also open to patients with Hodgkin Lymp…
Eligibility
- Age range
- 18–95 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * (1) Histologically confirmed relapsed/refractory HL, PMBCL, GZL, and TCL including the below subtypes: * 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 * Subcutaneous Panniculitis T-Cell Lymphoma * Arm 2: CTCL * Mycosis Fungoides * Sezary Syndrome * Arm 3: exploratory cohort * Classic HL * PMBCL * GZL * (2) All…
Interventions
- DrugRuxolitinib
Patients 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.
- DrugPembrolizumab
Pembrolizumab 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.
Location
- Columbia University Irving Medical CenterNew York, New York