Clinical trial · Interventional
Patient-donor Vaccination in the Context of Allogeneic Bone Marrow Transplant With Post-transplant Cyclophosphamide
Patient-donor Vaccination in the Context of Allogeneic Bone Marrow Transplant (BMT) With High-dose Post Transplantation Cyclophosphamide.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual and loss of funding.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Transplant-Related Cancer | Transplant-Related Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Havrix | Biological | — | UNRESOLVED |
| PCV13 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Donor PCV13
- description
- Donors receive PCV13 prior to bone marrow donation.
- interventionNames
- Biological: PCV13
- type
- ACTIVE_COMPARATOR
- label
- Donor Havrix
- description
- Donors receive Havrix prior to bone marrow donation.
- interventionNames
- Biological: Havrix
- type
- ACTIVE_COMPARATOR
- label
- Recipient vaccine
- description
- Recipients receive Havrix and PCV13 post bone marrow transplant.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available