For prevention of acute GVHD after allogeneic hematopoietic cell transplantation 100 patients with hematological malignancies who underwent Allo stem cell transplantation were randomly assigned to group A and B to receive azithromycin or placebo. Patients and the transplantation team were blinded for the assigned arm. Age 16-60 and malignant disease is inclusion criteria and age below16 and non malignant disease is exclusion criteria. Patients of 2 groups receive drug or placebo 500mg daily beginning at the start of the conditioning regimen (day 6 pre-transplantation) and continuing through day 12 post-transplantation. All subjects received their usual immunosuppressive regimen within the study period. Clinical assessment of acute GVHD and oral mucositis were done with scoring system in weekly periods from day 0-100 post-transplant.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403281030N16
Registration date:2014-04-05, 1393/01/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-05, 1393/01/16
Registrant information
Name
Mahdi Jalili
Name of organization / entity
Hematology-Oncology & SCT Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2662
Email address
m_jalili@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hematology, Oncology and SCT Research Center
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Azithromycin in prophylaxis of acute GVHD following allo-SCT in Hematology- oncology research center of shariati Hospital
Public title
Evaluation efficacy of Azithromycin in prophylaxis of bone marrow transplant complication
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 16-60 years old; malignant hematologic disease; allogeneic stem cell transplantation and first stem cell transplantation.
Exclusion criteria: age below 16 years old; non malignant disease; second stem cell transplantation.
Age
From 16 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hematology, Oncology and SCT Research Center
Street address
Kargar Ave Shariati Hospital
City
Tehran
Postal code
Approval date
2013-08-18, 1392/05/27
Ethics committee reference number
27/05/92
Health conditions studied
1
Description of health condition studied
Acute myeloblastic leukaemia
ICD-10 code
C92.0
ICD-10 code description
Acute myeloblastic leukaemia
2
Description of health condition studied
Acute lymphoblastic leukaemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukaemia
3
Description of health condition studied
Chronic myeloid leukaemia
ICD-10 code
C92.1
ICD-10 code description
Chronic myeloid leukaemia
4
Description of health condition studied
Multiple myeloma
ICD-10 code
C90.0
ICD-10 code description
Multiple myeloma
Primary outcomes
1
Description
Acute GVHD
Timepoint
Every week till 100 day after transplantation
Method of measurement
Clinical assessment
Secondary outcomes
1
Description
Oral mucositis
Timepoint
Every week till 100 day after transplantation
Method of measurement
Clinical assessment
Intervention groups
1
Description
Azithromycine 500g orally from day -6 to +12 of transplantation
Category
Treatment - Drugs
2
Description
Placebo 500g orally from day -6 to +12 of transplantation
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology, Oncology and SCT Research Center
Full name of responsible person
Ardeshir Ghavamzadeh
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hematology, Oncology and SCT Research Center
Full name of responsible person
Kamran Alimoghadam
Street address
Kargar Ave. Shariati Hospital
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hematology, Oncology and SCT Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hematology, Oncology and SCT Research Center
Full name of responsible person
Maryam Barkhordar
Position
Fellowship of oncology
Other areas of specialty/work
Street address
Kargar Ave. Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8490 2635
Fax
Email
maryam.barkhordar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hematology, Oncology and SCT Research Center
Full name of responsible person
Ardeshi Ghavamzadeh
Position
Professor
Other areas of specialty/work
Street address
Kargar Ave Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8490 2635
Fax
Email
horcbmt@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hematology, Oncology and SCT Research Center
Full name of responsible person
Maryam Barkhordar
Position
Felloship of Oncology
Other areas of specialty/work
Street address
Kargar Ave. Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8490 2635
Fax
Email
maryam.barkhordar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)