Post-transplant Lymphoproliferative Disorder Clinical Trial
Official title:
Phase II Study of Single Agent Obinutuzumab in Relapsed/Refractory Post-Transplant Lymphoproliferative Disorder (PTLD)
Patients with post transplant lymphoproliferative disorder (PTLD) that have been treated
with at least one type of chemotherapy, but whose lymphoma is not responding or coming back
after the previous treatment will be asked to participate in this study.
This clinical trial uses a drug called Obinutuzumab. The Food and Drug Administration (FDA)
has approved Obinutuzumab for sale in the United States for certain diseases. Obinutuzumab
is still being studied in clinical trials to learn more about what its side effects are and
whether or not it is effective in the disease or condition being studied. Obinutuzumab is
considered an investigational drug in this study
Obinutuzumab (GA101) is an antibody directed against cluster of differentiation antigen 20
(CD20). Antibodies are protein that are part of the immune system that can target cancer
cells. Obinutuzumab sticks to a target called CD20. CD20 is an important molecule on some
cancer cells (including non-Hodgkin lymphoma) and some normal cells of the immune system.
This study is being done to test if the study drug has an effect on post transplant
lymphoproliferative disorder and to see how lymphoma will respond to the study drug.
Primary Objective:
• To determine the overall response rate of obinutuzumab in relapsed/refractory
post-transplant lymphoproliferative disorder (PTLD) in both solid organ transplant (SOT) and
bone marrow transplant (BMT) patients
Secondary Objectives:
- Complete remission (CR) rate
- Duration of response (DOR)
- Progression free survival (PFS)
- Overall survival (OS)
- Time to treatment failure (TTF)
- Safety and tolerability of obinutuzumab
Patient Population:
Relapsed or refractory post-transplant lymphoproliferative disorder (PTLD) patients who have
received at least one prior therapy
Study Design:
Phase II study of single agent obinutuzumab in relapsed/refractory (RR) post-transplant
lymphoproliferative disorder (PTLD) in both SOT and BMT patients
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