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Patient-donor Vaccination in the Context of Allogeneic Bone Marrow Transplant (BMT) With High-dose Post Transplantation Cyclophosphamide.


N/A
18 Years
N/A
Open (Enrolling)
Both
Transplant-Related Cancer

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Trial Information

Patient-donor Vaccination in the Context of Allogeneic Bone Marrow Transplant (BMT) With High-dose Post Transplantation Cyclophosphamide.


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


Inclusion Criteria:



Patients inclusion for study:

1. Patient age > 18 years.

2. 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:

1. Receipt of the type of myeloablative or nonmyeloablative BMT

2. 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.

Exclusion Criteria:

Patients exclusion for study entry:

1. Hypersensitivity to either the components of hepatitis A vaccine (including neomycin)
or the components of the PCV7 and PCV13 vaccines (including diphtheria toxin).

2. Severe latex allergy.

Patients exclusion for vaccine:

1. Graft failure.

2. 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.

3. Systemic immunosuppression for GVHD treatment or prophylaxis within 4 weeks (+/- 5
days) prior to vaccination.

4. Pregnant or breastfeeding

Donors exclusion:

1. Hypersensitivity to both the components of hepatitis A vaccine (including neomycin)
and the components of the PCV7 and PCV13 vaccines (including diphtheria toxin).

2. Severe latex allergy.

3. Expected to be on systemic immunosuppressants between the time of vaccination and the
bone marrow donation.

4. Pregnant or breastfeeding

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Yvette Kasamon, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Institutional Review Board

Study ID:

J10140

NCT ID:

NCT01282216

Start Date:

April 2011

Completion Date:

December 2015

Related Keywords:

  • Transplant-Related Cancer

Name

Location

Sidney Kimmel Comprehensive Cancer CenterLutherville, Maryland