Patient-donor Vaccination in the Context of Allogeneic Bone Marrow Transplant With Post-transplant Cyclophosphamide
This research is being done to understand the effects of certain types of bone marrow transplant (BMT) on the immune system. Your doctors are planning a BMT, using one of your family members as the bone marrow donor, for your cancer. Part of that BMT involves a chemotherapy drug, called Cyclophosphamide (Cytoxan), given after the transplant. This research is being done to understand the effects of Cyclophosphamide on the immune system.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Patient-donor Vaccination in the Context of Allogeneic Bone Marrow Transplant (BMT) With High-dose Post Transplantation Cyclophosphamide.|
- To determine whether the vaccine-specific T cell immunity observed in the patient is augmented when the vaccine is also given to the bone marrow donor [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To characterize vaccine-specific antibody titers in the transplant recipient. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
|Active Comparator: Hepatitis A vaccine||
Biological: Hepatitis A
1440 ELISA units, or 1 mL, IM
Other Name: Havrix
|Active Comparator: PCV 13||
Biological: PCV 13
0.5 mL IM
Other Name: Prevnar-13
The research will involve giving your donor a vaccine against a certain infection, before the bone marrow donation: either a vaccine against hepatitis (the hepatitis A vaccine), or a vaccine against pneumonia (Prevnar). You will then get both of these vaccines following your transplant. By studying how much these vaccines may improve your immune system, we hope to better understand the effects of the BMT with Cyclophosphamide on the immune cells.
Prevnar is a pneumococcal vaccine (pneumococcus is a bacteria that can cause pneumonia and other infections). It is approved by the Food and Drug Administration (FDA) for the prevention of infections in children. It is not usually given to adults. Hepatitis A vaccine is approved by the FDA for the prevention of hepatitis A (a liver infection) in children and adults.
The vaccines are not approved for bone marrow donors or for vaccinating adults after BMT (using these vaccines in this research is investigational). The FDA is allowing the use of these vaccines in this research study.
Certain people getting BMT followed by Cyclophosphamide may join, if their donors might also join. Your bone marrow donor must take part in this study, in order for you to continue on this study
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282216
|Contact: Yvette Kasamon, M.D.||email@example.com|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center||Recruiting|
|Baltimore, Maryland, United States, 21231|
|Contact: Yvette Kasamon, M.D. 410-955-8839 firstname.lastname@example.org|
|Principal Investigator: Yvette Kasamon, M.D.|
|Principal Investigator:||Yvette Kasamon, M.D.||Johns Hopkins University|