- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01856803
Anti-thymocyte Globulins for Graft-versus-host Disease Prophylaxis
September 23, 2020 updated by: Xiaojun Huang,MD, Peking University People's Hospital
Anti-thymocyte Globulins for GVHD Prophylaxis After HLA-matched Sibling Stem Cell Transplantation in Patients at 40 Years of Age or More With Hematological Malignancies
Age is a risk factor for graft-versus-host disease (GVHD) after human leukocyte antigen (HLA)-matched sibling allogeneic stem cell transplantation (allo-SCT).
The incidence of acute GVHD is significantly higher in patients at 40 years of age or more than those at 18 to 39 years of age after allo-SCT.
It was found that Anti-thymocyte globulins can be used for prophylaxis of both acute and chronic GVHD after allo-SCT.Prophylaxis of GVHD using ATG in patients at 40 years of age or more in matched sibling allo-SCT settings might significantly decrease the incidence of acute and chronic GVHD and the incidence of late effect after transplantation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Prophylaxis for GVHD included CSA, MTX and MMF±ATG.
In the trial group, CSA was started intravenously on day -1, at the dosage of 3 mg/kg, and switched to oral formulation as soon as the patient was able to take medication after engraftment.
The dosage was adjusted to maintain a trough blood level of 200-300ng/ml.
MMF was administered orally, 0.25g every 12 hours, from day -1 before transplantation to day 30 after transplantation.
The dosage of MTX was 15 mg/m2, administered i.v. on day 1, and 10 mg/m2 on days 3, 6, and 11 after transplantation.
ATG (Thymoglobulin 2.5mg/kg per day i.v.) on days -2 through -1.
In the control group, CSA was started intravenously on day -1, at the dosage of 3 mg/kg, and switched to oral formulation as soon as the patient was able to take medication after engraftment.
The dosage was adjusted to maintain a trough blood level of 200-300ng/ml.
MMF was administered orally, 0.25g every 12 hours, from day -1 before transplantation to day 30 after transplantation.
The dosage of MTX was 15 mg/m2, administered i.v. on day 1, and 10 mg/m2 on days 3, 6, and 11 after transplantation.
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100044
- Peking University People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Standard-risk of recipients with hematological malignancies (including AML-CR1, ALL-CR1, CML-CP, MDS-RA, RARS,RCMD,RAEB-1); age from 40 to 60; having HLA-matched sibling donor; Eastern Cooperative Oncology Group (ECOG)≤1, ejection fraction (EF)≥50%; bilirubin≤35µmol/L; AST, and ALT lower than or equall to two-fold baseline;creatinie≤130µmol/L.
Exclusion Criteria:
- Active, uncontrolled infection; severe allergy to ATG, including shock or laryngeal edema; secondary stem cell transplant recipient; haplidentical recipients; matched unrelated donor recipients; non-myeloablative condioning regimen recipients; EF<50%; bilirubin>35µmol/L; AST, and ALT higher than two-fold baseline; creatinie>130µmol/L.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: routine prophylaxis
In this group, CSA plus MMF and MTX adopted as prevention of GVHD.
|
|
EXPERIMENTAL: ATG prophylaxis
In this group,ATG+MMF+CsA+MTX was adopted as prevention of GVHD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of acute GVHD, and chronic GVHD
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 1, 2013
Primary Completion (ACTUAL)
June 1, 2018
Study Completion (ACTUAL)
June 1, 2019
Study Registration Dates
First Submitted
May 15, 2013
First Submitted That Met QC Criteria
May 15, 2013
First Posted (ESTIMATE)
May 17, 2013
Study Record Updates
Last Update Posted (ACTUAL)
September 25, 2020
Last Update Submitted That Met QC Criteria
September 23, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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