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| ID | Type | Description | Link |
|---|---|---|---|
| P01CA015396 | U.S. NIH Grant/Contract | View source | |
| NA_00044665 | Other Identifier | JHM IRB |
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Low accrual and loss of funding.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donor PCV13 | Active Comparator | Donors receive PCV13 prior to bone marrow donation. |
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| Donor Havrix | Active Comparator | Donors receive Havrix prior to bone marrow donation. |
|
| Recipient vaccine | Active Comparator | Recipients receive Havrix and PCV13 post bone marrow transplant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Havrix | Biological | 1440 ELISA units, or 1 mL, IM |
|
| Measure | Description | Time Frame |
|---|---|---|
| T-cell Immunity Augmentation | Number of participants in which patient-donor pairs were not pre-immune to hepatitis A or CRM197, show augmented T-cell immunity when the vaccine is also given to the bone marrow donor. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recipient Vaccine-specific T-cell Response Post-transplant, Before Vaccination | Number of participants with a greater T-cell response after receiving transplant from a donor who received a vaccine, before receiving post-transplant vaccination. | up to 6 months |
| Recipient Vaccine-specific T-cell Response After Post-transplantation Vaccine |
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Inclusion Criteria:
Patients inclusion for study:
Patient age > 18 years.
Plan to undergo one of the following types of transplant, using bone marrow from a related donor:
Patients inclusion for vaccine:
Donors inclusion:
1. Donor age > 18 years.
Exclusion Criteria:
Patients exclusion for study entry:
Patients exclusion for vaccine:
Donors exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| RIchard Ambinder, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21231 | United States |
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8 recipients and 8 donors were screen failures prior to starting the study. 8 additional donors were vaccinated, but their intended recipients were never vaccinated and were replaced on study due to early relapse or graft failure. Data for the latter 8 donors has been lost and their arm assignment cannot be determined.
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| ID | Title | Description |
|---|---|---|
| FG000 | Donor PCV13 | Donors receive PCV13 prior to bone marrow donation. |
| FG001 | Donor Havrix | Donors receive Havrix prior to bone marrow donation. |
| FG002 | Recipient Vaccine | Recipients receive Havrix and PCV13 post bone marrow transplant. |
| FG003 | Donor - Assignment Unknown | Donors in this group received either PCV13 or Havrix. Assignment cannot be determined due to missing study data. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Data for 8 donors has been lost and their arm assignment cannot be determined; therefore, donor vaccine arms/groups are combined in this module.
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| ID | Title | Description |
|---|---|---|
| BG000 | Donor Vaccine | Donors are randomized to receive either Havrix or PCV13 prior to bone marrow donation. |
| BG001 | Recipient Vaccine | Recipients receive Havrix and PCV13 post bone marrow transplant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | T-cell Immunity Augmentation | Number of participants in which patient-donor pairs were not pre-immune to hepatitis A or CRM197, show augmented T-cell immunity when the vaccine is also given to the bone marrow donor. | Samples collected were inadequate for analysis, therefore data could not be collected to assess this outcome measure. | Posted | up to 6 months |
|
Up to 1 month
Only unexpected or serious adverse events that were considered related to either vaccine were tracked and reported. Adverse events were captured systematically by investigator assessment for at least 10 days for donors and at least 28 days for recipients. Data for 8 donors has been lost and their arm assignment cannot be determined, therefore donor vaccine arms/groups are combined in this module
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Donor Vaccine | Donors are randomized to receive either Havrix or PCV13 prior to bone marrow donation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rich Ambinder, MD | Johns Hopkins University | 4109558839 | rambind1@jhmi.edu |
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| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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Only the study pharmacist was unblinded.
| PCV13 | Biological | 0.5 mL IM |
|
|
Number of participants with a greater T-cell response after receiving transplant from a donor who received a vaccine, and after receiving post-transplant vaccination. |
| up to 6 months |
| Physician Decision |
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| Relapse |
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| Death |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Recipient Vaccine-specific T-cell Response Post-transplant, Before Vaccination | Number of participants with a greater T-cell response after receiving transplant from a donor who received a vaccine, before receiving post-transplant vaccination. | Samples collected were inadequate for analysis, therefore data could not be collected to assess this outcome measure. | Posted | up to 6 months |
|
|
| Secondary | Recipient Vaccine-specific T-cell Response After Post-transplantation Vaccine | Number of participants with a greater T-cell response after receiving transplant from a donor who received a vaccine, and after receiving post-transplant vaccination. | Samples collected were inadequate for analysis, therefore data could not be collected to assess this outcome measure. | Posted | up to 6 months |
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Recipient Vaccine | Recipients receive Havrix and PCV13 post bone marrow transplant. | 2 | 52 | 0 | 52 | 0 | 52 |
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| D045424 |
| Complex Mixtures |