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Treatment ineffective
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The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine with cyclosporine alone for the prevention of graft-versus-host disease.
This research is being done because there is no completely safe and effective prevention for graft-versus-host disease. It is known that cyclosporine helps with GVHD but we would like to know if the addition of basiliximab will decrease the incidence and/or severity of GVHD after a transplant known as nonmyeloablative ("mini" transplant).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | 60mg/kg/day for two consecutive days (-7,-6). | ||
| Fludarabine | Drug | 25mg/m2/day for 5 consecutive days | ||
| Cyclosporine | Drug | 3mg/kg/day will be given by continuous intravenous infusion beginning on Day -1. | ||
| Mycophenolate mofetil | Drug | 1000 mg will be administered through day +60 and then discontinued if there is no GVHD. | ||
| Basiliximab | Drug | 20mg , will be given by intravenous infusion (without an in-line filter) over at least 15 minutes beginning 3 days after engraftment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Acute Grade II-IV GVHD | Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities. | until 30 days after stem cell transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's). | until 30 days after stem cell transplant | |
| Number of Days for Absolute Neutrophil Count to Recover | Average number of day per patient for absolute neutrophil count to recover(> 500/mm3 for 3 consecutive days). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Nelson, MD | Indiana Universtiy School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana Universtiy Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Basiliximab 20 mg | All patients that received Basiliximab 20 mg monoclonal therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion) |
| Time to Resolution of Cytopenias: Platelet Transfusion Independence | Average number of days per patient for resolution of cytopenias. | From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion) |
| Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria. | Number of patients who died due to transplant related toxicities | up to 2 years after stem cell transplant |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Basiliximab 20 mg | All patients that received Basiliximab 20 mg monoclonal therapy |
| 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 |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | Number of Patients With Acute Grade II-IV GVHD | Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities. | All patient that received study drug | Number | participants | until 30 days after stem cell transplant |
|
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| Secondary | Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's). | ITT population. All patient that received study drug | Number | participants | until 30 days after stem cell transplant |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Days for Absolute Neutrophil Count to Recover | Average number of day per patient for absolute neutrophil count to recover(> 500/mm3 for 3 consecutive days). | ITT: All patient that received study drug | Mean | Standard Deviation | days per patient | From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion) |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Resolution of Cytopenias: Platelet Transfusion Independence | Average number of days per patient for resolution of cytopenias. | IIT: All patients that received study drug. | Mean | Standard Deviation | days per patient | From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion) |
|
| |||||||||||||||||||||||||||
| Secondary | Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria. | Number of patients who died due to transplant related toxicities | Intent To Treat: All patients that received study drug | Number | participants | up to 2 years after stem cell 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 | Basiliximab 20 mg | All patients that received Basiliximab 20 mg monoclonal therapy | 4 | 10 | 0 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GvHD | Immune system disorders | GvHD | Systematic Assessment |
|
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Four patients experienced grade 3-4 GVHD and this study was stopped.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Nelson, MD | Indiana University School of Medicine | 317-278-6871 | ronelson@iupui.edu |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D008228 | Lymphoma, Non-Hodgkin |
| D020522 | Lymphoma, Mantle-Cell |
| D006689 | Hodgkin Disease |
| D009101 | Multiple Myeloma |
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015448 | Leukemia, B-Cell |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D009190 | Myelodysplastic Syndromes |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| D016572 | Cyclosporine |
| D009173 | Mycophenolic Acid |
| D000077552 | Basiliximab |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Categories |
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