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| Name | Class |
|---|---|
| Baylor College of Medicine | OTHER |
| The Methodist Hospital Research Institute | OTHER |
| Center for Cell and Gene Therapy, Baylor College of Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Recall Response Rate | The proportion of participants with antibody recall response along with 95% confidence intervals will be calculated. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Immunoglobulin Levels | Changes from baseline to several time points during follow-up will be calculated. | up to 12 months |
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INCLUSION CRITERIA:
Inclusion Criteria for Donors:
Inclusion Criteria for Recipients:
EXCLUSION CRITERIA:
Exclusion Criteria for Donors:
Exclusion Criteria for Recipients to Receive FIRST Tetanus Immunization:
Exclusion Criteria for Recipients to Receive SUBSEQUENT Tetanus Immunization:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Krance, MD | Texas Childrens Hospital / Baylor College of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Childen's Hospital | Houston | Texas | 77030 | United States | ||
| The Methodist Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm: Tetanus Toxoid | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm: Tetanus Toxoid | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Antibody Recall Response Rate | The proportion of participants with antibody recall response along with 95% confidence intervals will be calculated. | One participant was off study on day 68 and not included in this analysis. | Posted | Number | 95% Confidence Interval | proportion of participants | 4 months |
|
Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.
All adverse events were collected using CTCAE 3.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm: Tetanus Toxoid | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert A. Krance | Baylor College of Medicine | 832-824-4661 | rakrance@txch.org |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D009190 | Myelodysplastic Syndromes |
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
|
| Houston |
| Texas |
| 77030 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Immunoglobulin Levels | Changes from baseline to several time points during follow-up will be calculated. | 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. | Posted | Median | Inter-Quartile Range | MG/DL | up to 12 months |
|
|
|
| 0 |
| 7 |
| 2 |
| 7 |
| 7 |
| 7 |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Infection - Other: Gastrointestinal Abdomen | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | CTCAE 4.0 | Systematic Assessment |
|
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Bicarbonate, serum-low | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Bilirubin (hyperbilirubinemia) | Investigations | CTCAE 4.0 | Systematic Assessment |
|
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
|
| Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Mucosal infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE 4.0 | Systematic Assessment |
|
| Fatigue (lethargy, malaise, asthenia) | General disorders | CTCAE 4.0 | Systematic Assessment |
|
| Febrile neutropenia(fever of unknown origin wo clinically or microbiologically documented infection) | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment | ANC < 1.0x10e9/L,fever >=38.5 degrees C |
|
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAE 4.0 | Systematic Assessment |
|
| GGT (gamma-Glutamyl transpeptidase) | Investigations | CTCAE 4.0 | Systematic Assessment |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Glucose, serum-low (hypoglycemia) | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Hemorrhage, GU - Urinary NOS | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Infection(documented clinically or microbiologically) with Grade 3 or 4 neutrophils-Bladder(urinary) | Infections and infestations | CTCAE 4.0 | Systematic Assessment | ANC <1.0 x 10e9/L |
|
| Infection - Other: Mucosa | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
|
| Lipase | Investigations | CTCAE 4.0 | Systematic Assessment |
|
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Mucositis/stomatitis (clinical exam) - Oral cavity | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| PTT (Partial Thromboplastin Time) | Investigations | CTCAE 4.0 | Systematic Assessment |
|
| Pain - Abdomen NOS | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Pain - Back | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
|
| Pain - Bladder | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
|
| Pain - Bone | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
|
| Pain - Extremity-limb | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
|
| Pain - Head/headache | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Pain - Joint | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
|
| Pain - Other: Headache | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Pain - Other: Oral Cavity | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Pain - Pain NOS | General disorders | CTCAE 4.0 | Systematic Assessment |
|
| Pain - Vagina | Reproductive system and breast disorders | CTCAE 4.0 | Systematic Assessment |
|
| Personality/behavioral | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
|
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
|
| Pulmonary/Upper Respiratory - Other: Rhinorrhea | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
|
| Pulmonary/Upper Respiratory - Other: Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
|
| Rigors/chills | General disorders | CTCAE 4.0 | Systematic Assessment |
|
| Sexual/Reproductive Function - Other: Menstrual cramps | Reproductive system and breast disorders | CTCAE 4.0 | Systematic Assessment |
|
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Supraventricular and nodal arrhythmia - Sinus arrhythmia | Cardiac disorders | CTCAE 4.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Triglyceride, serum-high (hypertriglyceridemia) | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
|
| IgA Change at 12 months |
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| IgG Change at 3 months |
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| IgG Change at 6 months |
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| IgG Change at 12 months |
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| IgM Change at 3 months |
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| IgM Change at 6 months |
|
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| IgM Change at 12 months |
|
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