Transplant-Related CancerPhase 2NCT01282216
Patient-donor Vaccination in the Context of Allogeneic Bone Marrow Transplant With Post-transplant Cyclophosphamide
A Phase 2 study testing Havrix and PCV13 in people with Transplant-Related Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transplant-Related Cancer
- What is being tested?
- Havrix and PCV13
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jan 2016
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- Myeloablative, HLA matched or partially HLA-mismatched (haploidentical), related-donor bone marrow transplantation that includes high-dose posttransplantation Cy
- Nonmyeloablative, HLA matched or partially HLA-mismatched, related-donor bone marrow transplantation that includes high-dose posttransplantation Cy Note: Patients who receive posttransplantation rituximab are eligible.
- Patients inclusion for vaccine:
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- Receipt of the type of myeloablative or nonmyeloablative BMT
- The bone marrow donor has received the pre-bone marrow harvest vaccine (either Prevnar or hepatitis A vaccine) on this study.
- Donors inclusion:
- 1. Donor age > 18 years.
Who cannot join
- Patients exclusion for study entry:
- Hypersensitivity to either the components of hepatitis A vaccine (including neomycin) or the components of the PCV7 and PCV13 vaccines (including diphtheria toxin).
- Severe latex allergy.
- Patients exclusion for vaccine:
- Graft failure.
- Disease progression or relapse, or disease persistence requiring treatment.Note: Patients with asymptomatic or low-volume disease progression or relapse may be eligible, determined on a case-by-case basis by the PI.
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- Systemic immunosuppression for GVHD treatment or prophylaxis within 4 weeks (+/- 5 days) prior to vaccination.
- Pregnant or breastfeeding
- Donors exclusion:
- Hypersensitivity to both the components of hepatitis A vaccine (including neomycin) and the components of the PCV7 and PCV13 vaccines (including diphtheria toxin).
- Severe latex allergy.
- Expected to be on systemic immunosuppressants between the time of vaccination and the bone marrow donation.
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
About this study
Official title: Patient-donor Vaccination in the Context of Allogeneic Bone Marrow Transplant (BMT) With High-dose Post Transplantation 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.
Read the detailed description
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
- Conditions
- Transplant-Related Cancer
- Being tested
- Havrix, PCV13
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HavrixBiological
Also called Hepatitis A vaccine
1440 ELISA units, or 1 mL, IM
PCV13Biological
Also called Prevnar-13
0.5 mL IM
| Study group | Role | What they receive |
|---|---|---|
| Donor PCV13 | Active comparator | Donors receive PCV13 prior to bone marrow donation. Receives: Biological: PCV13 |
| Donor Havrix | Active comparator | Donors receive Havrix prior to bone marrow donation. Receives: Biological: Havrix |
| Recipient vaccine | Active comparator | Recipients receive Havrix and PCV13 post bone marrow transplant. Receives: Biological: Havrix; Biological: PCV13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Secondary outcomes (2)
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.
Measured: up to 6 months
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Low accrual and loss of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Transplant-Related CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- RIchard Ambinder, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282216
- Sponsor's protocol ID
- J10140
- Other IDs
- P01CA015396, NA_00044665
- Status last verified
- May 2019
- First submitted
- 13 Jan 2011
- Last updated
- 30 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No