A total of 30 patients admitted to Bone Marrow Transplant Clinic of Dr. Shariati Hospital who underwent allogen bone marrow transplantation due to leukemia, thalassemia, multiple myeloma, and aplastic anemia, and have clinical signs of chronic coetaneous Graft Versus-Host Disease (CGVHD) whose symptoms are not improved by using corticosteroids and cyclosporine will be under treatment with Imatinib Mesylate for six months; 100 mg Imatinib Mesylate daily for the first month, 200 mg daily for the second and third months, and 400 mg daily for the next three months is prescribed. Before treatment and after six months, the extent of coetaneous involvement will be calculated in percentage. The intensity of the involvement will be determined through biopsy in pathology as well. Patients are included in the study with consent and in full awareness
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302261030N12
Registration date:2013-06-03, 1392/03/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-03, 1392/03/13
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
2012-08-28, 1391/06/07
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Imatinib Mesylate in the treatment of refractory cutaneous chronic Graft Versus-Host Disease
Public title
Effect of Imatinib Mesylate in patients undergone allogeneic bone marrow transplantation who show chronic coetaneous involvement Graft Versus-Host Disease.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria
1- The patient shall undergo allogen bone marrow transplantation and have clinical and pathological cutaneous CGVHD criteria.
2- Patient’s cutaneous signs are not improved by taking corticosteroids with doses of 0.5 mg/kg at least for 3 months and cyclosporine.
3- The cutaneous signs shall be active.
4- The patient shall be aged between 16 to 60 years old.
Exclusion Criteria
1- Pregnancy
2- Having a history of taking Rituximab.
Age
From 16 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hematology-Oncology and SCT Research Center Ethics Committee
Street address
Kargar Ave. Shariati Hospital
City
Tehran
Postal code
Approval date
2012-07-22, 1391/05/01
Ethics committee reference number
1391/5/1
Health conditions studied
1
Description of health condition studied
cutaneous cGVHD
ICD-10 code
T86.0
ICD-10 code description
Graft-versus-host reaction or disease
Primary outcomes
1
Description
The extent of cutaneous involvment
Timepoint
At the start of treatment and in the end of 6 month
Method of measurement
Skin examination
Secondary outcomes
1
Description
Extent of skin involvement in pathology
Timepoint
At the start of treatment and in the end of 6 month
Method of measurement
Severity of involvement in pathology
2
Description
Side effect frequency
Timepoint
Every month after treatment up to 6 months
Method of measurement
Examination and fallowing treatment
Intervention groups
1
Description
Imatinib: 100 mg Imatinib Mesylate daily for the first month, 200 mg daily for the second and third months, and 400 mg daily for the next three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology-Oncology and SCT Research Center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hematology-Oncology and SCT Research Center
Full name of responsible person
Zohreh Shahabi
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
Marjan Mehri
Position
MD
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 scientific inquiries
Contact
Name of organization / entity
Hematology-Oncology and SCT Research Center
Full name of responsible person
Marjan Mehri
Position
MD
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
Mahdi Jalili
Position
MD
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
Sharing plan
Deidentified Individual Participant Data Set (IPD)