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


N/A
3 Years
70 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome, Hodgkin Lymphoma, Non-Hodgkin Lymphoma

Thank you

Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Number of patients with antibody recall response at 4 months after Stem cell transplant

Outcome Description:

To determine antibody recall responses in patients receiving allogeneic hematopoietic stem cell transplants

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

Catherine Bollard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine

Authority:

United States: Institutional Review Board

Study ID:

H-21942-TAR

NCT ID:

NCT01611298

Start Date:

March 2008

Completion Date:

December 2016

Related Keywords:

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

Name

Location

The Methodist HospitalHouston, Texas  77030
Texas Childen's HospitalHouston, Texas  77030