Trial Outcomes & Findings for Safety and Efficacy of Alemtuzumab in Pediatric Intestinal Transplantation (NCT NCT01208337)
NCT ID: NCT01208337
Last Updated: 2023-03-08
Results Overview
Asses safety of Alemtuzumab in combination with Tacrolimus and steroids in twenty-three pediatric intestine allograft recipients by calculating the rate in which PTLD occurred amongst the study population.
COMPLETED
PHASE2
23 participants
5 Year
2023-03-08
Participant Flow
Participant milestones
| Measure |
Alemtuzumab Induction
Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.
Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
One-year Follow-up
|
23
|
|
Overall Study
Five-year Follow-up
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Alemtuzumab Induction
Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.
Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone
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|---|---|
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Overall Study
Death
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3
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Baseline Characteristics
Safety and Efficacy of Alemtuzumab in Pediatric Intestinal Transplantation
Baseline characteristics by cohort
| Measure |
Alemtuzumab Induction
n=23 Participants
Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.
Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone
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|---|---|
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Age, Continuous
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5.7 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Primary Isolated Intestine Transplant
|
21 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 5 YearPopulation: Alemtuzumab induction at the time of transplant may reduce the rate of early acute cellular rejection compared with historical controls, but may increase rate of alternate post-transplant complications, such as Post Transplant Lymphoproliferative Disorder (PTLD).
Asses safety of Alemtuzumab in combination with Tacrolimus and steroids in twenty-three pediatric intestine allograft recipients by calculating the rate in which PTLD occurred amongst the study population.
Outcome measures
| Measure |
Alemtuzumab Induction
n=23 Participants
Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.
Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone
|
|---|---|
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Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)
|
6 participants
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Alemtuzumab induction at the time of transplant may reduce the rate of early acute cellular rejection compared with historical controls, but may increase rate of alternate post-transplant complications, such as Post Transplant Lymphoproliferative Disorder (PTLD).
Biopsy-proven incidence of acute cellular rejection
Outcome measures
| Measure |
Alemtuzumab Induction
n=23 Participants
Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.
Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone
|
|---|---|
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Incidence of Biopsy-proven Acute Cellular Rejection
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12 participants
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SECONDARY outcome
Timeframe: 1 yearPopulation: Induction of Alemtuzumab at time of transplant may increase the likelihood of weaning off steroids sooner after transplant than patients who did not receive Alemtuzumab as induction immunosuppression medication.
As part of analysis for assessing effectiveness and safety of Alemtuzumab Induction at the time of transplant, it is important to assess the incidence in which patients enrolled were able to wean off of steroids post-transplant compared to historical controls.
Outcome measures
| Measure |
Alemtuzumab Induction
n=21 Participants
Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.
Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone
|
|---|---|
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Incidence of Patients in Whom Steroids Are Not Used
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5 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: It is believed that patients whom received Alemtuzumab at the time of transplant and continue post-transplant with functioning grafts will have Tacrolimus whole blood concentrations less than 10ng/ml.
Tacrolimus whole blood concentrations less than 10 ng/ml
Outcome measures
| Measure |
Alemtuzumab Induction
n=21 Participants
Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.
Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone
|
|---|---|
|
Incidence of Patients in Whom Tacrolimus Whole Blood Concentration Less Than 10 ng/ml Are Being Used at 1-year Follow-up.
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16 participants
|
SECONDARY outcome
Timeframe: 5 yearPopulation: Induction of Alemtuzumab at time of transplant may increase the likelihood of weaning off steroids sooner after transplant than patients who did not receive Alemtuzumab as induction immunosuppression medication.
As part of analysis for assessing effectiveness and safety of Alemtuzumab Induction at the time of transplant, it is important to assess the incidence in which patients enrolled were able to wean off of steroids post-transplant compared to historical controls.
Outcome measures
| Measure |
Alemtuzumab Induction
n=21 Participants
Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.
Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone
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|---|---|
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Incidence of Patients in Whom Steroids Are Not Used
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9 participants
|
Adverse Events
Alemtuzumab Induction
Serious adverse events
| Measure |
Alemtuzumab Induction
n=23 participants at risk
Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.
Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone
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|---|---|
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Infections and infestations
PTLD
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26.1%
6/23 • Number of events 6 • 5 years from time of enrollment
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place