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The purpose of this study is to determine if we can prevent Epstein Barr Virus lymphomas by the monthly administration of an (antibody) protein against B lymphocytes called Rituximab. Although this medicine has been approved by the Food and Drug Administration to treat patients with other types of lymphomas, and has been used to treat a small number of patients with EBV lymphomas and other types of B-cell leukemias, it has not been approved to try and prevent EBV-lymphomas. Use of Rituximab to try to prevent EBV-lymphomas is therefore experimental.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab | Experimental | Patients following a T cell depleted HLA-mis-matched related or unrelated hematopoietic stem cell transplant (HSCT) will be treated with monthly Rituximab. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Rituximab 375 mg/m^2 starting approximately 1 month post transplant (no later than day 45), and continuing monthly until the CD4 cell count is > 200 cells/ul or a maximum of 6 doses have been given. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Rituximab Prophylaxis | The following stopping rules will be employed to determine that the risks of graft failure, severe GvHD, treatment-related mortality, infection, and EBV-LPD in study patients are not increased over expected. In addition, patients will be removed from study if they develop irreversible non-hematologic Grade III toxicity or any Grade IV toxicity felt to be related or possibly related to study drug. | 3 months post transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trudy Small, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT | To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT | To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Safety of Rituximab Prophylaxis | The following stopping rules will be employed to determine that the risks of graft failure, severe GvHD, treatment-related mortality, infection, and EBV-LPD in study patients are not increased over expected. In addition, patients will be removed from study if they develop irreversible non-hematologic Grade III toxicity or any Grade IV toxicity felt to be related or possibly related to study drug. | Please see Adverse Event section for more details. | Posted | Number | participants | 3 months post transplant |
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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 | Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT | To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT | 6 | 26 | 23 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection w.out neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Infection with grade 3/4 neut | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Neutrophils/gran | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alkaline phosphatase | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Bilirubin | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Catheter-rel inf | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Hemoglobin (Hgb) | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
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| Infection w.out neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
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| Leukocytes | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Lymphopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Neutrophils/gran | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Platelets | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
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| SGOT (AST) | Investigations | CTCAE (2.0) | Systematic Assessment |
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| SGPT (ALT) | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Papadopoulos, Esperanza, MD (Attending) | Memorial Sloan Kettering Cancer Center | +1212-639-8276 | papadope@mskcc.org |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D007938 | Leukemia |
| D009190 | Myelodysplastic Syndromes |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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