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did not accrue enough patients.
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The primary objective of this study is to assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific antibodies and in those with active disease.
Primary Objective
- To assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific anti-HLA antibodies and in those with active disease
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conditioning Regimen I | Experimental | Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG) |
|
| Conditioning Regimen II | Experimental | Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melphalan | Drug | Melphalan is given daily for 2 days, overlapping with the completion of fludarabine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cord Blood Engraftment by Day 100 | Percent of subjects with cord blood engraftment on or before day 100. Detectable cord blood engraftment should be present by day 100 in at least 50% of patients. As of 44 days post-transplant, only haploidentical donor chimerism achieved in the one patient enrolled in the Fludarabine, melphalan, and ATG arm. There were no cord cells detected for this patient. | 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| Survival at Day 100 | Percent of subjects who are alive 100 days after the stem cell infusion | 100 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Artz, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fludarabine, Melphalan, and ATG | Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG) Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine. Fludarabine: Fludarabine is given through the vein daily for 5 days. Antithymocyte Globulin (ATG): ATG is given every other day for 4 days. |
| FG001 | Fludarabine, Busulfan, ATG, and TBI | Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI). Fludarabine: Fludarabine is given through the vein daily for 5 days. Antithymocyte Globulin (ATG): ATG is given every other day for 4 days. Busulfan: Busulfan is given daily for 4 days. Total Body Irradiation (TBI): TBI is given twice on the last day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fludarabine, Melphalan, and ATG | Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG) Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine. Fludarabine: Fludarabine is given through the vein daily for 5 days. Antithymocyte Globulin (ATG): ATG is given every other day for 4 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number |
| 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 | Cord Blood Engraftment by Day 100 | Percent of subjects with cord blood engraftment on or before day 100. Detectable cord blood engraftment should be present by day 100 in at least 50% of patients. As of 44 days post-transplant, only haploidentical donor chimerism achieved in the one patient enrolled in the Fludarabine, melphalan, and ATG arm. There were no cord cells detected for this patient. | The only enrolled patient failed to complete the study due to death. | Posted | 100 days |
|
100 days
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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 | Fludarabine, Melphalan, and ATG | Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG) Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine. Fludarabine: Fludarabine is given through the vein daily for 5 days. Antithymocyte Globulin (ATG): ATG is given every other day for 4 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Septic shock | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute graft versus host disease | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Artz, MD, MS | The University of Chicago Medicine | (773) 834-8980 | aartz@medicine.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D008558 | Melphalan |
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D000961 | Antilymphocyte Serum |
| D002066 | Busulfan |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
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| Fludarabine | Drug | Fludarabine is given through the vein daily for 5 days. |
|
|
| Antithymocyte Globulin (ATG) | Drug | ATG is given every other day for 4 days. |
|
| Busulfan | Drug | Busulfan is given daily for 4 days. |
|
|
| Total Body Irradiation (TBI) | Drug | TBI is given twice on the last day. |
|
| BG001 |
| Fludarabine, Busulfan, ATG, and TBI |
Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI). Fludarabine: Fludarabine is given through the vein daily for 5 days. Antithymocyte Globulin (ATG): ATG is given every other day for 4 days. Busulfan: Busulfan is given daily for 4 days. Total Body Irradiation (TBI): TBI is given twice on the last day. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Gender | Number | participants |
|
| OG001 | Fludarabine, Busulfan, ATG, and TBI | Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI). Fludarabine: Fludarabine is given through the vein daily for 5 days. Antithymocyte Globulin (ATG): ATG is given every other day for 4 days. Busulfan: Busulfan is given daily for 4 days. Total Body Irradiation (TBI): TBI is given twice on the last day. |
|
| Secondary | Survival at Day 100 | Percent of subjects who are alive 100 days after the stem cell infusion | The only enrolled patient failed to complete the study due to death. | Posted | 100 days |
|
|
| 1 |
| 1 |
| 1 |
| 1 |
| EG001 | Fludarabine, Busulfan, ATG, and TBI | Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI). Fludarabine: Fludarabine is given through the vein daily for 5 days. Antithymocyte Globulin (ATG): ATG is given every other day for 4 days. Busulfan: Busulfan is given daily for 4 days. Total Body Irradiation (TBI): TBI is given twice on the last day. | 0 | 0 | 0 | 0 |
| Renal failure | Renal and urinary disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
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| D009930 |
| Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |