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| ID | Type | Description | Link |
|---|---|---|---|
| UAB-0775 | Other Identifier | UAB Cancer Center study number |
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Accrual goals could not be met within a timely manner
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A non-myeloablative treatment strategy and uniform selection criteria will enable patients with a variety of low grade B-Cell malignancies to attain long term disease control without unacceptably high treatment related mortality.
Non myeloablative transplant aims to achieve the immunological advantage of graft versus tumor effect as conventional myeloablative therapy without causing high treatment related toxicities. Non myeloablative transplant has been gaining wider acceptance as a way to achieve longer disease free and over all survival in patients with low grade B-cell malignancies, which otherwise is an incurable disease. Recent studies of non-myeloablative HSCT have demonstrated the powerful effect of graft versus leukemia alone against myeloma and other malignant B-cell malignancies if the transplant is performed for low grade, low volume disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non Myeloablative Treatment | Other | Non-myeloablative Transplant Conditioning Chemotherapy : Fludarabine - 30 mg/m2/day x 3 days Total Body Irradiation - 200cGy x1 dose Infusion of Stem Cells - On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine | Drug | Fludarabine 30 mg/m2/day x 3 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progressive Free Survival Post Transplant | subjects surviving without disease progression at 100 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology. | 100 days post transplant |
| Progressive Free Survival Post Transplant | Subjects surviving without disease progression 180 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology. | 180 days post transplant |
| Progressive Free Survival Post Transplant | Subjects surviving without disease progression 365 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology. | 365 days post transplant |
| Progression Free Survival Post Transplant | Subjects surviving without disease progression 2 years after transplant as evidenced by no new disease showing on radiologic scans and / or bone marrow pathology. | 2 years post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Non-relapse Treatment Related Mortality | Death related to treatment without relapse within 100 days after transplant | Within 100 days post transplant |
| Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William P. Vaughan, MD | University of Alabama in Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama in Birmingham BMT/CT Program Outpatient Clinic | Birmingham | Alabama | 35249-6979 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Trial | Single Arm Intervention trial as noted in interventions section Fludarabine: Fludarabine 30 mg/m2/day x 3 days Total Body Irradiation: TBI 200cGy x1 dose on transplant day Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Total Body Irradiation |
| Radiation |
TBI 200cGy x1 dose on transplant day |
|
| Infusion of Stem Cells | Other | On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight. |
|
Measured by number of participants that have chimerism study results that show the number of donor cells and the number of recipient cells present in the blood after post-transplant lymphocyte infusions continue to be predominately either donor or recipient.
| Post transplant up to 100 days post transplant |
| Composite Incidence of Acute and Chronic Graft Versus Host Disease | Up to 100 days post transplant. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Trial | Single Arm Intervention trial as noted in interventions section Fludarabine: Fludarabine 30 mg/m2/day x 3 days Total Body Irradiation: TBI 200cGy x1 dose on transplant day Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight. |
| 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 | No |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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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 | Progressive Free Survival Post Transplant | subjects surviving without disease progression at 100 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology. | Posted | Number | participants | 100 days post transplant |
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| |||||||||||||||||||||||||||
| Secondary | Non-relapse Treatment Related Mortality | Death related to treatment without relapse within 100 days after transplant | Posted | Number | participants | Within 100 days post transplant |
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| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant | Measured by number of participants that have chimerism study results that show the number of donor cells and the number of recipient cells present in the blood after post-transplant lymphocyte infusions continue to be predominately either donor or recipient. | Posted | Number | participant | Post transplant up to 100 days post transplant |
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| Secondary | Composite Incidence of Acute and Chronic Graft Versus Host Disease | Posted | Number | participants | Up to 100 days post transplant. |
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| |||||||||||||||||||||||||||||
| Primary | Progressive Free Survival Post Transplant | Subjects surviving without disease progression 180 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology. | Posted | Number | participants | 180 days post transplant |
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| ||||||||||||||||||||||||||||
| Primary | Progressive Free Survival Post Transplant | Subjects surviving without disease progression 365 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology. | Posted | Number | participants | 365 days post transplant |
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| ||||||||||||||||||||||||||||
| Primary | Progression Free Survival Post Transplant | Subjects surviving without disease progression 2 years after transplant as evidenced by no new disease showing on radiologic scans and / or bone marrow pathology. | Posted | Number | participants | 2 years 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 | Single Arm Trial | Single Arm Intervention trial as noted in interventions section Fludarabine: Fludarabine 30 mg/m2/day x 3 days Total Body Irradiation: TBI 200cGy x1 dose on transplant day Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight. | 3 | 5 | 0 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| RSV pneumonia Infection | Respiratory, thoracic and mediastinal disorders |
| |||
| Klebsiella pneumonia Infection | Respiratory, thoracic and mediastinal disorders |
| |||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Pneumonia not otherwise specified |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Vaughan, MD | UAB | 20-934-0066 | liwilliams@uabmc.edu |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008228 | Lymphoma, Non-Hodgkin |
| D020522 | Lymphoma, Mantle-Cell |
| D015448 | Leukemia, B-Cell |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |
| D008206 | Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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