Nivolumab Maintenance Therapy After Autologous Stem Cell Transplant in Hodgkin Lymphoma Pts at Relapse/Progression Risk
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03436862|
Recruitment Status : Active, not recruiting
First Posted : February 19, 2018
Last Update Posted : May 17, 2022
|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|
|Actual Primary Completion Date :||May 5, 2022|
|Estimated Study Completion Date :||December 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) to evaluate safety and tolerability of nivolumab as maintenance therapy [ 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).
- Progression-free survival (PFS) for Nivolumab Maintenance Therapy [ Time Frame: 1 year after date of first dose of study drug for each patient ]Kaplan-Meier PFS estimate at 12 month interval when nivolumab is administered as maintenance therapy. Progression-Free Survival (PFS), defined as the time from the first day of study drug administration (Day 1) to disease progression as defined by the Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification (Cheson et al. 2014), or death on study. Patients who are alive and free from disease progression will be censored at the date of last tumor assessment.
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
|United States, Colorado|
|Colorado Blood Cancer Institute|
|Denver, Colorado, United States, 80218|
|United States, Missouri|
|Kansas City, Missouri, United States, 64132|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|St. David's South Austin Medical Center|
|Austin, Texas, United States, 78704|
|Texas Transplant Institute|
|San Antonio, Texas, United States, 78229|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Study Chair:||Carlos Bachier, MD||SCRI Development Innovations, LLC|