Donor-Derived Humoral Immunity, Hematopoietic Stem Cell Transplantation, TAR
Completed · Not applicable
Conditions studied: Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome, Hodgkin Lymphoma, Non-Hodgkin Lymphoma
In brief
This research study is for subjects that are receiving a bone marrow transplant. As part of the transplant subjects will receive stem cells from a donor who has agreed to donate stem cells for them. Unfortunately, it takes a long time for the immune system to recover after a bone marrow transplant. This makes it more likely for patients to develop serious infections. This study is being done to better understand how the immune system will recover after transplant. The immune system includes the cells that help fight infection. This study will help investigators understand which patients are at risk for developing infections after transplant. All children and adults receive standard vaccines (shots) during their lifetime to provide protection from many different infections. One such infection is tetanus, a bacteria that can cause life-threatening problems. After transplant patients no longer have protection from infections such as tetanus. Therefore, most patients need to receive all their vaccine (shots) again after transplant. This is usually done 1-2 years after transplant, since it may take that long for patients to have a normal immune system. However, the investigators believe that the time it will take for the patient to develop normal protection against tetanus can be shortened if both the patient and the patient's stem cell donor receive a tetanus vaccine. The goal of this study is to determine if giving a tetanus vaccine to the donor and the patient will provide the patient with enough protection (immunity) to prevent infection following bone marrow transplant.
Key facts
- Study ID
- NCT01611298
- Run by
- Robert Krance
- People needed
- 7
- Starts
- 2008-03-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2020-04-21
Who can join
Age: 3 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Inclusion Criteria for Donors:
- Related donor of bone marrow or peripheral blood stem cell product
- Age 3 to 70 years
- Informed consent form signed and sent to Research Coordinator
- Inclusion Criteria for Recipients:
- Patient with acute lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, myelodysplastic syndrome, myeloproliferative disorder, Hodgkin lymphoma, non-Hodgkin lymphoma, or a non-malignant disease requiring allogeneic stem cell transplant
- Age between 3 and 70 years
- Informed consent form signed and sent to Research Coordinator
You may not qualify if…
- Exclusion Criteria for Donors:
- Allergy to tetanus vaccine
- Pregnant or lactating
- Has received tetanus booster within preceding 12 months
- Exclusion Criteria for Recipients to Receive FIRST Tetanus Immunization:
- Allergy to tetanus vaccine
- Has received tetanus booster within preceding 12 months
- Has active malignancy (not in remission)
- Exclusion Criteria for Recipients to Receive SUBSEQUENT Tetanus Immunization:
- Allergy to tetanus vaccine
- Active, acute graft vs. host disease (GVHD) greater than or equal to grade II or chronic graft vs. host disease (GVHD)
- Disease relapse - less than 75% donor chimerism (peripheral blood or bone marrow)
- Active infection (bacterial, viral, fungal) or fever (temperature greater than 100.5 celsius)
Where it is running
- Texas Childen's Hospital — Houston, Texas, United States
- The Methodist Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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