A study to evaluate the efficacy of Atorvastatin in the prophylaxis of acute graft-versus-host disease in allogeneic hematopoietic stem cell transplantation (HSCT)
Evaluating the efficacy of Atorvastatin in the prophylaxis of acute graft-versus-host disease (Acute GVHD) in recipients of allogeneic hematopoietic stem cell transplantation (HSCT).
Design
This is a randomized, double-blind, placebo-controlled, parallel-group trial in which patients are divided into groups: A and B based on a computer-generated block randomization list. Then, patients and donors receive their medicine based on the protocol and are monitored at each follow-up visit.
Settings and conduct
Allo-HSCT candidates in Shariati hospital were divided into two groups (Atorvastatin and placebo recipients) based on a computer-generated block randomization list. Both groups receive treatment from day 14 before transplantation to day 180 after transplantation or until the incidence of severe GVHD (grade II-IV). Data are obtained by researchers in the BMT ward, post-transplant clinic, and emergency unit for hematology patients through a questionnaire in two steps: 1) before and during hospitalization in BMT wards, 2) after hospital discharge, and follow-up clinic visits.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with a history of hematologic malignancies or bone marrow failure syndromes
Recipient age: 18 to 60 years of age
A fully HLA-matched family donor
Exclusion criteria:
Pregnant women or lactating mothers
Intervention groups
Allo-HSCT candidates in Shariati Hospital bone marrow transplant wards were divided into two groups: Atorvastatin (40mg/daily) and Placebo recipients. Both groups receive treatment from day 14 before transplantation to day 180 after transplantation or until the incidence of severe GVHD (grade II-IV).
Main outcome variables
Acute GVHD (skin,liver,gut): the first 100 days after transplantation
Chronic GVHD: after 100 days of transplantation
Mucositis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140818018842N27
Registration date:2022-12-03, 1401/09/12
Registration timing:retrospective
Last update:2022-12-03, 1401/09/12
Update count:0
Registration date
2022-12-03, 1401/09/12
Registrant information
Name
Leyla Sharifi Aliabadi
Name of organization / entity
Research Institute for Hematology, Oncology and Stem Cell Transplantation,Tehran University of Medic
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2635
Email address
ctu@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
2015-08-23, 1394/06/01
Actual recruitment end date
2019-02-20, 1397/12/01
Trial completion date
2019-08-23, 1398/06/01
Scientific title
A study to evaluate the efficacy of Atorvastatin in the prophylaxis of acute graft-versus-host disease in allogeneic hematopoietic stem cell transplantation (HSCT)
Public title
A study to evaluate the effect of Atorvastatin in GvHD
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Donor age : 18 years or above
Normal liver function in donors
Normal renal function in recipients
KPS =>60 for donors
Patients with a history of hematologic malignancies or bone marrow failure syndromes
Recipient age: 18 to 60 years
A fully HLA‐matched family donor
LVEF=>40% for recipients
Normal liver function in recipients
Normal renal function in donors
KPS =>70 for recipients
There is no no prohibition for patients who already received Atorvastatin
Exclusion criteria:
Pregnant women and lactating mothers
Positive history of hypersensitivity to Atorvastatin in donors
HIV-positive donors
HIV-positive recipients
Positive history of hypersensitivity to Atorvastatin in recipients
Patients receiving ATG
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
75
Actual sample size reached:
74
Randomization (investigator's opinion)
Randomized
Randomization description
According to a computer-generated block randomization list, patients are given a code, and then they are divided into groups A (Atorvastatin recipients) and B (placebo recipients). In this study, participants, caregivers, and researchers are blinded to group assignments. The results are reported by the person not involved in the study after completion of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
According to a computer-generated block randomization list, patients are given a code, and then they are divided into groups A (Atorvastatin recipients) and B (placebo recipients). In this study, participants, caregivers, and researchers are blinded to group assignments. The results are reported by the person not involved in the study after completion of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Ethics Committee of Tehran University of Medical Sciences, Keshavararz Blvd. ,Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2015-05-26, 1394/03/05
Ethics committee reference number
IR.TUMS.REC1394.1435
Health conditions studied
1
Description of health condition studied
Acute lymphoblastic leukemia [ALL]
ICD-10 code
c91.0
ICD-10 code description
2
Description of health condition studied
Acute myeloid leukemia [AML]
ICD-10 code
C92.0
ICD-10 code description
Acute myeloblastic leukemia
Primary outcomes
1
Description
Acute GVHD
Timepoint
Weekly monitoring until 100 days after transplant
Method of measurement
Clinical assessment
2
Description
Oral mucositis
Timepoint
Weekly monitoring until 100 days after transplant
Method of measurement
Clinical assessment
Secondary outcomes
1
Description
Overall survival
Timepoint
Three years after transplantation
Method of measurement
Patient follow-up
2
Description
Disease-free survival
Timepoint
Three years after transplantation (1- 2 month intervals)
Method of measurement
Clinical assessment
3
Description
Atorvastatin safety
Timepoint
Since 14 days before transplantation until 100 days after transplatation with 15-,30-,60- ,and 90-day intervals
Method of measurement
Clinical assessment as well as monitoring liver and muscle enzymes if necessary
Intervention groups
1
Description
Intervention group: In this group, Atorvastatin 40 mg (Abidi Pharmaceutical Co.) is given daily to both donor and transplant recipients from 14 days before transplantation until 180 days after transplantation (for transplant recipient) or until the incidence of side effects or severe GVHD.
Category
Treatment - Drugs
2
Description
Control group: In this group, Placebo 40 mg (Abidi Pharmaceutical Co. ) is given daily to both donor and transplant recipients from 14 days before transplantation until 180 days after transplantation (for transplant recipient) or until the incidence of side effects or severe GVHD.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology, Oncology and Stem Cell Transplantation Research Center
Full name of responsible person
Mohammad Vaezi
Street address
Kargar-e-shomali Ave., Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713131
Phone
+98 21 8490 2635
Fax
+98 21 8800 4140
Email
vaezi.mohammad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seied Asadollah Mousavi
Street address
Kargar-e-Shomali Ave., Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713131
Phone
+98 21 8490 2635
Fax
+98 21 8800 4140
Email
ctu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hematology, Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sciences.
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parsa Rostami
Position
Hematology- Medical Oncology Fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Kargar-e-shomali Ave., Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713131
Phone
+98 21 8490 2635
Fax
+98 21 8800 4140
Email
rostami.parsa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Vaezi
Position
Subspecialty in Hematology and Medical Oncology
Latest degree
Subspecialist
Other areas of specialty/work
Hematology and Medical Oncology
Street address
Kargar-e-Shomali Ave., Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713131
Phone
+98 21 8490 2635
Fax
+98 21 8800 4140
Email
vaezi.mohammad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leyla Sharifi Aliabadi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kargar-e-Shomali Ave., Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713131
Phone
+98 21 8490 2635
Fax
+98 21 8800 4140
Email
l-sharifi@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD