Nivolumab as Maintenance Therapy After Autologous Stem Cell Transplantation in Patients With Hodgkin Lymphoma at Risk of Relapse or Progression
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|ClinicalTrials.gov Identifier: NCT03436862|
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : July 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma||Drug: Nivolumab||Phase 2|
The primary objective of this study is to evaluate safety and tolerability of nivolumab as maintenance therapy early after autologous stem cell transplant in patients with Hodgkin's Lymphoma (HL).
Eligible patients will receive nivolumab (240 mg IV) every 2 weeks (± 2 days as long as interval between doses is 12-16 days) starting 45-120 post-transplant for up to a maximum of 6 months of treatment. Response to treatment will be assessed 6 months and 1 year post-transplant using Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Single Arm Study of Nivolumab as Maintenance Therapy After Autologous Stem Cell Transplantation in Patients With Hodgkin Lymphoma at Risk of Relapse or Progression|
|Actual Study Start Date :||May 23, 2018|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2023|
Patients will receive Nivolumab 240 mg by intravenous infusion (IV) starting Day 45-120 post-transplant (±10 days) every 2 weeks for up to a maximum of 6 months of treatment.
Nivolumab 240 mg IV infusion over 60 minutes given every 2 weeks for up to 6 months.
Other Name: Opdivo
- The incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) as a measure of safety [ Time Frame: Up to 6 months ]The reported incidence of AEs and SAEs with an onset on or after the initiation of therapy will be graded according to National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE).
- 12 month progression-free survival (PFS) [ Time Frame: 1 year post-transplant ]The number of patients who are progression-free at 12 months post-transplant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436862
|Contact: Sarah Cannon Development Innovations||844-710-6157||CANN.InnovationsMedical@sarahcannon.com|
|United States, Colorado|
|Colorado Blood Cancer Institute||Not yet recruiting|
|Denver, Colorado, United States, 80218|
|Principal Investigator: Richard Nash, MD|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator: Carlos Bachier, MD|
|United States, Texas|
|St. David's South Austin Medical Center||Recruiting|
|Austin, Texas, United States, 78704|
|Principal Investigator: Aravind Ramakrishnan, MD|
|Texas Transplant Institute||Not yet recruiting|
|San Antonio, Texas, United States, 78229|
|Principal Investigator: Cesar Freytes, MD|
|Study Chair:||Carlos Bachier, MD||SCRI Development Innovations, LLC|