Patient-donor Vaccination in the Context of Allogeneic Bone Marrow Transplant With Post-transplant Cyclophosphamide
Stopped early · Phase 2
Conditions studied: Transplant-Related Cancer
In brief
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.
Key facts
- Study ID
- NCT01282216
- Run by
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- People needed
- 120
- Starts
- 2011-04-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2019-05-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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:
- 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:
- Donor age > 18 years.
You may not qualify if…
- 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.
- 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
Where it is running
- Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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