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| ID | Type | Description | Link |
|---|---|---|---|
| IRB #11835 | Other Identifier | University of Oklahoma Health Sciences Center |
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To evaluate engraftment and toxicity of a reduced intensity preparative regimen for patients who receive a matched related or unrelated donor allogeneic stem cell transplant (ASCT) for malignant hematological diseases
Primary Endpoints:
Secondary Endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other | Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Busulfex, Fludarabine, ALemtuzumab | Drug | Busulfex 3.2 mg/kg/day for 2 days infused over 3 hours, Days -6 and Day-5 Fludarabine 30 mg/m2/day for 5 days on Day -6 to D-2 Alemtuzumab 10 mg/day IV on Days -5 to -1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Transplant Related Mortality (TRM) | At Day 100 post trans-plant | |
| Number of Participants Experiencing Engraftment Donor Chimerism (EDC) | At time of study termination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Relapse-Free | 100 days post-transplant | |
| Number of Participants Overall Survival as a Function of Time. | 100 days post transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Selby, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
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Recruitment began February 2005 and concluded around March 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Reduced Intensity Regimen | Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Reduced Intensity Regimen | Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants Experiencing Transplant Related Mortality (TRM) | Posted | Number | Participants | At Day 100 post trans-plant |
|
|
Day 100 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 | Reduced Intensity Regimen | Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intracranial hemorrhage - recurrence | Vascular disorders | Source Vocabulary | Non-systematic Assessment | Event determined to be "not related" to study participation; resulted in death of participant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Positive Cytomegalovirus cultures | Blood and lymphatic system disorders | Source Vocabulary | Non-systematic Assessment | Hospitalized for treatment and recovered without sequelae |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George Selby, MD | University of Oklahoma Health Sciences Center | 405/271-4022 | george-selby@ouhsc.edu |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D002066 | Busulfan |
| C024352 | fludarabine |
| D000074323 | Alemtuzumab |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Secondary | Number of Participants Relapse-Free | Last observation carried forward | Posted | Number | Participants | 100 days post-transplant |
|
|
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| Primary | Number of Participants Experiencing Engraftment Donor Chimerism (EDC) | Posted | Number | Participants | At time of study termination |
|
|
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| Secondary | Number of Participants Overall Survival as a Function of Time. | Last observation carried forward | Posted | Number | Participants | 100 days post transplant |
|
|
|
| 1 |
| 17 |
| 4 |
| 17 |
|
|
| Thrombocytopenia | Blood and lymphatic system disorders | Source Vocabulary | Non-systematic Assessment | Hospitalized and recovered without sequelae |
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| Blasts in bone marrow | Blood and lymphatic system disorders | Source Vocabulary | Non-systematic Assessment | Determined to be not related to study participation; recovered without sequelae |
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| Syncopal episode / Hypotension | General disorders | Source Vocabulary | Non-systematic Assessment | Determined to be "not related" to study participation; recovered without sequelae |
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| D008698 |
| Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| 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 |