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

Acute Lymphoblastic Leukemia Clinical Trial

— TAR  

Official title:

Transfer of Donor-Derived Humoral Immunity Following Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611298
• Other study ID #: H-21942-TAR
• Status: Completed
• Phase: N/A
• Start date: March 2008
• Est. completion date: July 2013

Study information

• Verified date: April 2020
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myelogenous Leukemia
• Chronic Myelogenous Leukemia
• Hodgkin Disease
• Hodgkin Lymphoma
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Lymphoma
• Lymphoma, Non-Hodgkin
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Non-Hodgkin Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Preleukemia

Intervention

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.

Locations

Country	Name	City	State
United States	Texas Childen's Hospital	Houston	Texas
United States	The Methodist Hospital	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Robert Krance	Baylor College of Medicine, Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody Recall Response Rate	The proportion of participants with antibody recall response along with 95% confidence intervals will be calculated.	4 months
Secondary	Change in Immunoglobulin Levels	Changes from baseline to several time points during follow-up will be calculated.	up to 12 months