Venae Sectio technique will be used to insert totally implantable access port (TIAP) by a surgeon

Punction of Vena Subclavia will be used to insert totally implantable access port (TIAP) by a radiologist.

surgical preparation of the cephalic vene to insert a totally implantable access port.

Venae sectio

radiological punction of the v. subclavia with Seldinger technique to implant a totally implantable access port

Punction of V. subclavia

Markus W Büchler, Prof. Dr.

The purpose of this trial is to investigate if the success rate of punction the vena subclavia (99% in retrospective studies) will be 15% higher than the success rate of venae sectio (80% in retro and prospective studies) for implantation of a totally implantable access ports.

PORTAS 2, Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port

Randomized Controlled Trial Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port

Heidelberg University

Prof. Dr. med. M. W. Büchler, Chairman Department of Surgery

Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Hodgkin Disease

Myeloproliferative Disorders

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Chronic Disease

Disease Attributes

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Myeloid Leukemia

Hodgkin Lymphoma

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

All Drugs and Chemicals

Vaccines

Immunologic Factors

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

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.

Tetanus

Robert Krance, MD

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.

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.

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

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

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

Changes from baseline to several time points during follow-up will be calculated.

Baylor College of Medicine

The Methodist Hospital Research Institute

Center for Cell and Gene Therapy, Baylor College of Medicine

Robert Krance

Prof, Pediatrics-Hema & Oncology

All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.

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

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.

Single Arm: Tetanus Toxoid

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Black

White

Race/Ethnicity, Customized

United States

Region of Enrollment

Dr. Robert A. Krance

One participant was off study on day 68 and not included in this analysis.

Antibody Recall Response Rate

IgA Change at 3 months

IgA Change at 6 months

IgA Change at 12 months

IgG Change at 3 months

IgG Change at 6 months

IgG Change at 12 months

IgM Change at 3 months

IgM Change at 6 months

IgM Change at 12 months

One participant was off study on day 68 and not included in this analysis. Six participants included in the analysis had at least one measurement at the follow-up time points. n=the number of participants with measurements for that time point.

Change in Immunoglobulin Levels

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PORTAS 2, Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port	NCT00600444	Cancer	Venae sectio Punction of V. ...	-	Heidelberg University
PORTAS 2, Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port	NCT00600444	Cancer	Venae sectio Punction of V. ...	-	Heidelberg University
Donor-Derived Humoral Immunity, Hematopoietic Stem Cell Transplantation, TAR	NCT01611298	Acute Lymphobla... Acute Myelogeno... Chronic Myeloge... Myelodysplastic... Hodgkin Lymphom... Non-Hodgkin Lym...	Tetanus	3 Years - 70 Years	Baylor College of Medicine
Donor-Derived Humoral Immunity, Hematopoietic Stem Cell Transplantation, TAR	NCT01611298	Acute Lymphobla... Acute Myelogeno... Chronic Myeloge... Myelodysplastic... Hodgkin Lymphom... Non-Hodgkin Lym...	Tetanus	3 Years - 70 Years	Baylor College of Medicine

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