Acute Lymphoblastic LeukemiaTARNCT01611298
Donor-Derived Humoral Immunity, Hematopoietic Stem Cell Transplantation, TAR
A study testing Tetanus in people with Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia, run by Robert Krance at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia
- What is being tested?
- Tetanus
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2008to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Childen's Hospital
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome, Hodgkin Lymphoma, Non-Hodgkin Lymphoma
- Being tested
- Tetanus
- Keywords
- allogeneic stem cell transplant, malignant diseases, Acute lymphoblastic leukemia, acute myelogenous leukemia, Chronic myelogenous leukemia, myelodysplastic syndrome, Hodgkin lymphoma, non-Hodgkin lymphoma, myeloproliferative disorder, non-malignant disease
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelodysplastic Syndromes, Hodgkin Disease, Lymphoma, Non-Hodgkin, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetanusBiological
Also called Tetanus Toxoid vaccine
Stem cell transplant donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest.
Stem cell transplant recipients will receive one dose of tetanus toxoid 0.5mL intramuscularly (or subcutaneously if platelet count less than 50,000/uL) into deltoid or medial lateral thigh 7-10 days prior to stem cell transplant (FIRST dose).
Stem cell transplant recipients will receive a subsequent dose of tetanus toxoid 0.5mL given intramuscularly into deltoid or medial lateral thigh (or given subcutaneously if platelet count is less than 50,000/uL) approximately 3 months following allo stem cell transplant. Patients must meet re-evaluation criteria to receive injection.
| Study group | Role | What they receive |
|---|---|---|
| Single arm: Tetanus Toxoid | Experimental | SCT Donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest Receives: Biological: Tetanus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody Recall Response Rate
The proportion of participants with antibody recall response along with 95% confidence intervals will be calculated.
Measured: 4 months
Secondary outcomes (1)
Change in Immunoglobulin Levels
Changes from baseline to several time points during follow-up will be calculated.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startMar 2008
- Primary completionNov 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Krance
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine, The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
- Responsible party
- Sponsor-investigator, Robert Krance, Baylor College of Medicine
- Investigators
- Robert Krance, MD, Study director, Texas Childrens Hospital / Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611298
- Sponsor's protocol ID
- H-21942-TAR
- Acronym
- TAR
- Status last verified
- Apr 2020
- First submitted
- 11 Apr 2012
- Last updated
- 21 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfer of Donor-Derived Humoral Immunity Following Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01611298
- Acronym / sponsor ID
- TAR / H-21942-TAR
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome, Hodgkin Lymphoma, Non-Hodgkin Lymphoma
- Keywords
- allogeneic stem cell transplant, malignant diseases, Acute lymphoblastic leukemia, acute myelogenous leukemia, Chronic myelogenous leukemia, myelodysplastic syndrome, Hodgkin lymphoma, non-Hodgkin lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Robert KranceUniversity, hospital or other
- Collaborators
- Baylor College of Medicine, The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
- Study start
- Mar 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 Jun 2012 (estimated)
- Results
- Posted 21 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm: Tetanus Toxoid | Experimental | Biological: TetanusSCT Donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- 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
Key exclusion criteria (12 listed)
- Allergy to tetanus vaccine
- Pregnant or lactating
- Has received tetanus booster within preceding 12 months
- Allergy to tetanus vaccine
- Has received tetanus booster within preceding 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TetanusAlso: Tetanus Toxoid vaccineStem cell transplant donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest. Stem cell transplant recipients will receive one dose of tetanus toxoid 0.5mL intramuscularly (or subcutaneously if platelet count less than 50,000/uL) into deltoid or medial lateral thigh 7-10 days prior to stem cell transplant (FIRST dose). Stem cell transplant recipients will receive a subsequent dose of tetanus toxoid 0.5mL given intramuscularly into deltoid or medial lateral thigh (or given subcutaneously if platelet count is less than 50,000/uL) approximately 3 months following allo stem cell transplant. Patients must meet re-evaluation criteria to receive injection. | Biological | Single arm: Tetanus Toxoid |
Primary outcome
Antibody Recall Response Rate
Time frame: 4 months
The proportion of participants with antibody recall response along with 95% confidence intervals will be calculated.
1 secondary outcome
Change in Immunoglobulin Levels
Time frame: up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Krance, MD study director
Texas Childrens Hospital / Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetanus in people with Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia, run by Robert Krance at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody Recall Response Rate (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.