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The purpose of this study is:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Busulfan and fludarabine | Experimental | Intravenous busulfan (Busulfan®) in combination with fludarabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Busulfan | Drug | Daily intravenous dosing to target AVC |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose | Maximally tolerated area under the curve of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. The number reported will be an Area Under the Curve (AUC) measure reported in µmol-min/L. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall Survival measured as median survival in days | 5 years |
| Disease Free Survival | Disease Free Survival measured by median survival time in days |
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Inclusion Criteria:
Phase I portion:
Phase II portion:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Artz, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20919852 | Derived | O'Donnell PH, Artz AS, Undevia SD, Pai RK, Del Cerro P, Horowitz S, Godley LA, Hart J, Innocenti F, Larson RA, Odenike OM, Stock W, Van Besien K. Phase I study of dose-escalated busulfan with fludarabine and alemtuzumab as conditioning for allogeneic hematopoietic stem cell transplant: reduced clearance at high doses and occurrence of late sinusoidal obstruction syndrome/veno-occlusive disease. Leuk Lymphoma. 2010 Dec;51(12):2240-9. doi: 10.3109/10428194.2010.520773. Epub 2010 Oct 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Busulfan and Fludarabine | Intravenous busulfan (Busulfan®) in combination with fludarabine Busulfan: Daily intravenous dosing to target AVC Fludarabine: Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose. Campath: All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times). Stem Cell Transplant: Infusion of bone marrow and donors(related/ unrelated). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2013 |
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| Fludarabine |
| Drug |
Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose. |
|
| Campath | Drug | All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times). |
|
| Stem Cell Transplant | Procedure | Infusion of bone marrow and donors(related/ unrelated). |
|
| 5 years |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Busulfan and Fludarabine | Intravenous busulfan (Busulfan®) in combination with fludarabine Busulfan: Daily intravenous dosing to target AVC Fludarabine: Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose. Campath: All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times). Stem Cell Transplant: Infusion of bone marrow and donors(related/ unrelated). |
| 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 | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | Maximum Tolerated Dose | Maximally tolerated area under the curve of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. The number reported will be an Area Under the Curve (AUC) measure reported in µmol-min/L. | The 36 patients refer to the phase I portion of the study only. | Posted | Number | mmol-min/L | 5 years |
|
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall Survival measured as median survival in days | Posted | Median | 95% Confidence Interval | days | 5 years |
|
| |||||||||||||||||||||||||||
| Secondary | Disease Free Survival | Disease Free Survival measured by median survival time in days | Posted | Median | 95% Confidence Interval | days | 5 years |
|
|
10 years
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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 | Busulfan and Fludarabine | Intravenous busulfan (Busulfan®) in combination with fludarabine Busulfan: Daily intravenous dosing to target AVC Fludarabine: Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose. Campath: All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times). Stem Cell Transplant: Infusion of bone marrow and donors(related/ unrelated). | 45 | 49 | 1 | 49 | 1 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mental Status change | Nervous system disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Artz | UChicago | 773-834-8980 | aartz@medicine.bsd.uchicago.edu |
| Jan 30, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D002066 | Busulfan |
| C024352 | fludarabine |
| D000074323 | Alemtuzumab |
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| 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 |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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