Donor-Derived Humoral Immunity, Hematopoietic Stem Cell Transplantation, TAR
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Blood Cancer, Lymphoma, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 3 - 70 |
| Updated: | 1/1/2014 |
| Start Date: | March 2008 |
| End Date: | December 2016 |
| Contact: | Catherine Bollard, MD |
| Email: | cmbollar@txch.org |
| Phone: | 832-824-4781 |
Transfer of Donor-Derived Humoral Immunity Following Allogeneic Hematopoietic Stem Cell Transplantation
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.
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.
To participate in this study, patients will need to have given informed consent to have a
bone marrow transplant. Before receiving the tetanus vaccine, we would like to test the
patient's immune system against tetanus. We will again want to test the patient's immune
system against tetanus on the day the patient receives the bone marrow transplant.
Approximately 3 months after transplant, if the patient is still eligible, they will receive
an additional tetanus booster shot. We will again draw blood to test their immune system
against tetanus at the time points listed below.
TREATMENT PLAN:
If the subject meets eligibility requirements and consents to be part of this study, we will
collect 8 mL (1.7 teaspoons) of blood from the subject to test their immunity 7 to 10 days
before their bone marrow transplant. The subject will receive a tetanus vaccine (given as an
injection into the upper arm or thigh muscle) on that same day. We will then collect
approximately the same amount of blood (2 teaspoons) on the day the patient would receive
the bone marrow transplant. We will also collect the same amount of blood 1 week, 2 weeks, 4
weeks and 3 months, 6 months and 12 months after the transplant. This will help us to see
how the patients immune system responded to the vaccine.
Three months after the transplant, the patient will receive an additional tetanus vaccine
(known as a booster shot), but only if the patient is still eligible to receive it.
Patient's will only be eligible to receive the booster shot if they remain well and do not
have any other problems such as severe infection, graft versus host disease or relapse. We
will collect 8 ml (1.7 teaspoons) of blood 1 week, 2 weeks and 4 weeks after receiving the
booster shot to determine if they respond to the vaccine.
bone marrow transplant. Before receiving the tetanus vaccine, we would like to test the
patient's immune system against tetanus. We will again want to test the patient's immune
system against tetanus on the day the patient receives the bone marrow transplant.
Approximately 3 months after transplant, if the patient is still eligible, they will receive
an additional tetanus booster shot. We will again draw blood to test their immune system
against tetanus at the time points listed below.
TREATMENT PLAN:
If the subject meets eligibility requirements and consents to be part of this study, we will
collect 8 mL (1.7 teaspoons) of blood from the subject to test their immunity 7 to 10 days
before their bone marrow transplant. The subject will receive a tetanus vaccine (given as an
injection into the upper arm or thigh muscle) on that same day. We will then collect
approximately the same amount of blood (2 teaspoons) on the day the patient would receive
the bone marrow transplant. We will also collect the same amount of blood 1 week, 2 weeks, 4
weeks and 3 months, 6 months and 12 months after the transplant. This will help us to see
how the patients immune system responded to the vaccine.
Three months after the transplant, the patient will receive an additional tetanus vaccine
(known as a booster shot), but only if the patient is still eligible to receive it.
Patient's will only be eligible to receive the booster shot if they remain well and do not
have any other problems such as severe infection, graft versus host disease or relapse. We
will collect 8 ml (1.7 teaspoons) of blood 1 week, 2 weeks and 4 weeks after receiving the
booster shot to determine if they respond to the vaccine.
INCLUSION CRITERIA:
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
EXCLUSION CRITERIA:
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)
We found this trial at
2
sites
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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