Brentuximab Vedotin Plus AD in Non-bulky Limited Stage Hodgkin Lymphoma
|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: NCT02505269|
Recruitment Status : Completed
First Posted : July 22, 2015
Last Update Posted : June 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma||Drug: Brentuximab Vedotin Drug: Adriamycin Drug: Dacarbazine||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved brentuximab vedotin (brentuximab) as part of the initial treatment of Hodgkin lymphoma. Currently, brentuximab is FDA-approved for treatment of relapsed Hodgkin lymphoma.
- Brentuximab works by binding specifically to Hodgkin lymphoma cells, entering the cells, and then releasing the drug to destroy the cell.
- The chemotherapy drugs Adriamycin and Dacarbazine (AD) which which participants will receive in this research study are approved for use in people with Hodgkin Lymphoma.
- Patients will not receive planned radiation therapy, or the drugs bleomycin or vinblastine.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Brentuximab Vedotin Plus AD in Non-bulky Limited Stage Hodgkin Lymphoma|
|Actual Study Start Date :||August 7, 2015|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||June 2018|
Experimental: Brentuximab Vedotin
The following procedures will take place during study visits beginning after the screening procedures:
- Participants will receive combination therapy:
Drug: Brentuximab Vedotin
Other Name: Adcetris
- Complete Response Rate [ Time Frame: 4-6 months ]
- Overall Response Rate [ Time Frame: 4-6 months ]Kaplan-Meier method
- Rate of grade III and IV adverse events [ Time Frame: 4-6 months ]
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): NCT02505269
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Jeremy Abramson, MD||Massachusetts General Hospital|