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

NCT01611298 | Completed Results DMC

• 1 other identifier: H-21942-TAR
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief 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.

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; myeloproliferative disorder; non-malignant disease

Outcome Measures

Primary Outcomes (1)

• Antibody Recall Response Rate

  The proportion of participants with antibody recall response along with 95% confidence intervals will be calculated.

  4 months

Secondary Outcomes (1)

• Change in Immunoglobulin Levels

  up to 12 months

Study Arms (1)

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

Biological: Tetanus

Interventions

Tetanus BIOLOGICAL

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.

Also known as: Tetanus Toxoid vaccine

Single arm: Tetanus Toxoid

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Has active malignancy (not in remission)
• 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)

Sponsors & Collaborators

• Robert Krance: lead
• Baylor College of Medicine: collaborator
• The Methodist Hospital Research Institute: collaborator
• Center for Cell and Gene Therapy, Baylor College of Medicine: collaborator

Study Sites (2)

Texas Childen's Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes; Hodgkin Disease; Lymphoma, Non-Hodgkin; Myeloproliferative Disorders

Interventions

Tetanus Toxoid

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr. Robert A. Krance
• Organization: Baylor College of Medicine

rakrance@txch.org

832-824-4661

Study Officials

• Robert Krance, MD

  Texas Childrens Hospital / Baylor College of Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof, Pediatrics-Hema & Oncology

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: June 4, 2012
• Study Start: March 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: July 1, 2013
• Last Updated: April 21, 2020
• Results First Posted: April 21, 2020

Record last verified: 2020-04

Locations

US (2)