Donor-Derived Humoral Immunity, Hematopoietic Stem Cell Transplantation, TAR

This study has been completed.
Sponsor:
Collaborators:
Texas Children's Hospital
The Methodist Hospital System
Center for Cell and Gene Therapy, Baylor College of Medicine
Information provided by (Responsible Party):
Kathryn Leung, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01611298
First received: April 11, 2012
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Acute Lymphoblastic Leukemia
Acute Myelogenous Leukemia
Chronic Myelogenous Leukemia
Myelodysplastic Syndrome
Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Biological: Tetanus

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Transfer of Donor-Derived Humoral Immunity Following Allogeneic Hematopoietic Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Number of patients with antibody recall response at 4 months after Stem cell transplant [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    To determine antibody recall responses in patients receiving allogeneic hematopoietic stem cell transplants


Secondary Outcome Measures:
  • Change in immunoglobulin levels before, during and after stem cell transplant [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To determine immunoglobulin levels before, during and after stem cell transplant


Enrollment: 14
Study Start Date: March 2008
Study Completion Date: July 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Schedule of Tetanus Toxoid Administration
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
Biological: Tetanus

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.

Other Name: Tetanus Toxoid vaccine

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.

  Eligibility

Ages Eligible for Study:   3 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611298

Locations
United States, Texas
Texas Childen's Hospital
Houston, Texas, United States, 77030
The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Texas Children's Hospital
The Methodist Hospital System
Center for Cell and Gene Therapy, Baylor College of Medicine
Investigators
Principal Investigator: Kathryn Leung, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Kathryn Leung, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01611298     History of Changes
Other Study ID Numbers: H-21942-TAR, TAR
Study First Received: April 11, 2012
Last Updated: April 1, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:
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

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Lymphoma
Lymphoma, Non-Hodgkin
Myelodysplastic Syndromes
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Preleukemia
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Precancerous Conditions

ClinicalTrials.gov processed this record on October 22, 2014