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slow recruitment and no further drug supply
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The purpose is to determine if the addition of Maraviroc to a standard transplant regimen will reduce the incidence of graft versus host disease in children and young adults after a stem cell transplant.
In the first stage, drug levels will be obtained to establish appropriate dosing. In the second stage of the study the investigators will study the effects of using Maraviroc in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maraviroc | Experimental | Maraviroc administration will start on day -3 and will end on day +30 after stell cell transplant, making the total number of days of drug administration 34 days. Maraviroc will be administered twice daily orally or via enteral tube. Dosing of Maraviroc will be based on body surface area (starting with 100mg twice a day for BSA of 0.2 and up to 300mg twice a day for BSA greater than 1.73). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maraviroc | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Maraviroc | The ability to administer twice daily oral maraviroc in children and adults undergoing stem cell transplant in addition to routine standard graft versus host disease prophylaxis. | Up to day +100 |
| GVHD Incidence | Incidence of GVHD by day+100 | By day +100 |
| Area Under The Concentration-Time Curve (AUC) of Maraviroc | pK target >100ng/ml at day zero at the following time points : before the dose and 1, 2, 4, 6, 8, and 12 hours after maraviroc administration | Day 0 |
| Incidence of Visceral GVHD | determine the number of patients who develop visceral GVHD by day+100 | day+100 |
| Area Under The Concentration-Time Curve (AUC) of Maraviroc | pK target >100ng/ml at day 10 at the following time points : before the dose and 1, 2, 4, 6, 8, and 12 hours after maraviroc administration | Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival for patients who were enrolled and received maraviroc | By day +100 |
| Graft Failure | Failure to engraft and loss of graft. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pooja Khandelwal, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Maraviroc | Maraviroc administration will start on day -3 and will end on day +30 after stell cell transplant, making the total number of days of drug administration 34 days. Maraviroc will be administered twice daily orally or via enteral tube. Dosing of Maraviroc will be based on body surface area (starting with 100mg twice a day for BSA of 0.2 and up to 300mg twice a day for BSA greater than 1.73). Maraviroc |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
not different
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| ID | Title | Description |
|---|---|---|
| BG000 | Maraviroc | Maraviroc administration will start on day -3 and will end on day +30 after stell cell transplant, making the total number of days of drug administration 34 days. Maraviroc will be administered twice daily orally or via enteral tube. Dosing of Maraviroc will be based on body surface area (starting with 100mg twice a day for BSA of 0.2 and up to 300mg twice a day for BSA greater than 1.73). Maraviroc |
| 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 | Feasibility of Maraviroc | The ability to administer twice daily oral maraviroc in children and adults undergoing stem cell transplant in addition to routine standard graft versus host disease prophylaxis. | Posted | Count of Participants | Participants | Up to day +100 |
|
day+ 100 after BMT or 30 days after last maraviroc administration if patients withdrew from study
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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 | Maraviroc | Maraviroc administration will start on day -3 and will end on day +30 after stell cell transplant, making the total number of days of drug administration 34 days. Maraviroc will be administered twice daily orally or via enteral tube. Dosing of Maraviroc will be based on body surface area (starting with 100mg twice a day for BSA of 0.2 and up to 300mg twice a day for BSA greater than 1.73). Maraviroc |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| TMA | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
early termination leading to small number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pooja Khandelwal, MD | Cincinnati Children's Hospital Medical Center | 513-803-4762 | Pooja.Khandelwal@cchmc.org |
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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 | Mar 23, 2018 | Sep 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| By day +100 |
| Primary Disease Relapse | By day +100 |
| Toxicities | Incidence of toxicities due to drug | Up to day +100 |
| Infectious Complications | Infections complications which include asymptomatic viremias for EBV, Adenovirus, CMV, and/or viral disease, bacterial and fungal infections as documented by blood cultures. | Up to day +100 |
| Time to Neutrophil | Neutrophil engraftment is defined as the first of three consecutive measurements of ANC>500mcL over 3 or more days. | Up to day +100 |
| Time to Platelet Engraftment | Time to achieve platelets count of 20,000 without transfusions | days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | GVHD Incidence | Incidence of GVHD by day+100 | Posted | Count of Participants | Participants | By day +100 |
|
|
|
| Primary | Area Under The Concentration-Time Curve (AUC) of Maraviroc | pK target >100ng/ml at day zero at the following time points : before the dose and 1, 2, 4, 6, 8, and 12 hours after maraviroc administration | Posted | Mean | Standard Deviation | hour *ng/mL | Day 0 |
|
|
|
| Primary | Incidence of Visceral GVHD | determine the number of patients who develop visceral GVHD by day+100 | all patients enrolled on trial | Posted | Count of Participants | Participants | day+100 |
|
|
|
| Primary | Area Under The Concentration-Time Curve (AUC) of Maraviroc | pK target >100ng/ml at day 10 at the following time points : before the dose and 1, 2, 4, 6, 8, and 12 hours after maraviroc administration | Posted | Mean | Standard Deviation | hour*ng/mL | Day 10 |
|
|
|
| Secondary | Overall Survival | Overall survival for patients who were enrolled and received maraviroc | Posted | Count of Participants | Participants | By day +100 |
|
|
|
| Secondary | Graft Failure | Failure to engraft and loss of graft. | Posted | Count of Participants | Participants | By day +100 |
|
|
|
| Secondary | Primary Disease Relapse | Posted | Count of Participants | Participants | By day +100 |
|
|
|
| Secondary | Toxicities | Incidence of toxicities due to drug | Posted | Count of Participants | Participants | Up to day +100 |
|
|
|
| Secondary | Infectious Complications | Infections complications which include asymptomatic viremias for EBV, Adenovirus, CMV, and/or viral disease, bacterial and fungal infections as documented by blood cultures. | Posted | Number | patients | Up to day +100 |
|
|
|
| Secondary | Time to Neutrophil | Neutrophil engraftment is defined as the first of three consecutive measurements of ANC>500mcL over 3 or more days. | Posted | Median | Full Range | days | Up to day +100 |
|
|
|
| Secondary | Time to Platelet Engraftment | Time to achieve platelets count of 20,000 without transfusions | Posted | Median | Full Range | days | days |
|
|
|
| 4 |
| 31 |
| 11 |
| 31 |
| 16 |
| 31 |
| Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Colonic hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Autoimmune hepatitis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinusoidal Obstructive Syndrome | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Infection- Disseminated Adenoviremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection- Enterobacter Aerogenes Baceteremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection-Enterococcus Bacteremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection-Citrobacter and Klebsiella Bacteremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection- Klebsiella Pneumonia Bacteremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection- Staphylococcus Aureus Bacteremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection- CMV Viremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Immune System Other (Engraftment Syndrome) | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Allergic Reaction (Angioedema) | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment | Angioedema was not due to maraviroc as drug was stopped . This was experienced post anesthesia . |
|
| Blood Bilirubin- Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Altered mental status | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis due to CMV | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| respiratory distress | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| TMA/HUS | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinusoidal Obstructive Syndrome | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic reaction to Ambisome | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anaphylaxis to Cyclosporine | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| CMV viremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| catheter related infection ( MSSA bacteremia, staph aureus and bacillus) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Adenovirus in stool | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Adenovirus in blood | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| BK viremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Moraxella nonliquefaciens infection in blood | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| HHV6 blood | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Streptococcus infection in blood | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Klebsiella oxytoca infection in blood | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Candida in blood | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Escherichia Coli in blood | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| hemoglobin decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| WBC decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| ALT increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| AST increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| EBV |
|
| Adenovirus |
|
| Bk viremia |
|