Total 9 patients who have been affected by malignant hematologic disorders were selected and received conditioning and autologous stem cell transplantation in hospital and next day were discharged and followed up by outpatient stem cell transplantation team. Finally we assessed the feasibility of outpatient autologous stem cell transplantation by neutrophil and platelet recovery and early mortality.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711081030N6
Registration date:2009-05-02, 1388/02/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-05-02, 1388/02/12
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
Tehran University of Medical Sciences
Expected recruitment start date
2008-05-01, 1387/02/12
Expected recruitment end date
2008-12-01, 1387/09/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Feasibility of outpatient autologous stem cell transplantation in patients referred to shariati hospital
Public title
Outpatient autologous stem cell transplantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Acceptance of patient. 2- Patient is in a complete remission (CR1). 3- Performance score 80-100 or 0-2. 4- No heart, liver, kidneys or lungs dysfunction. 5- The distance from the patient’s home to the hospital should be no more than 60 minutes. 6- The existence of an educated care giver, with at least a diploma, who’s able to be with the patient twenty-four hours a day and seven days a week. 7- The patient should have suitable living conditions at home. 8 - The patient should not be heavily treated. Exclusion criteria: 1- Patients who don’t accept (to be out-patients). 2- Progressive or refractory disease. 3- A patient who has had several treatments before (heavily treated) 4- Creatinin >1.5 5- cardiac ejection fraction is less than %50 6- liver’s enzymes are twice as large as normal.
Age
From 14 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
9
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
Ethics Committee of Hematology-Oncology and SCT Research Center
Street address
Shariati Hospital, Kargar Ave.
City
Tehran
Postal code
Approval date
2008-10-18, 1387/07/27
Ethics committee reference number
418/الف/87/673
Health conditions studied
1
Description of health condition studied
Outpatient autologous stem cell transplantation
ICD-10 code
Z76.1
ICD-10 code description
Health supervision and care of foundling
Primary outcomes
1
Description
WBC recovery
Timepoint
One month after transplantation
Method of measurement
Absolute Neutrophil Count ≥ 0.5×10^9 /L
2
Description
Platelet recovery
Timepoint
One month after transplantation
Method of measurement
Platelet ≥20×10^9 /L
Secondary outcomes
1
Description
Early mortality
Timepoint
One year after transplantation
Method of measurement
Survival monitoring
Intervention groups
1
Description
Autologous stem cell transplantation as outpatient
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology-Oncology & SCT Research Center
Full name of responsible person
Street address
Shariati Hospital, Kargar Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Yonesian
Street address
Enghelab Sq.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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 & SCT Research Center
Full name of responsible person
Akram Karimi
Position
Coresponder / M.D.
Other areas of specialty/work
Street address
Shariati Hospital, Kargar Ave.
City
Tehran
Postal code
Phone
+98 21 8490 2668
Fax
Email
horcbmt@sina.tums.ac.ir
Web page address
http://horcsct.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hematology-Oncology and SCT Research Center
Full name of responsible person
Aboulghasem Allahyari
Position
Principal Investigator / Fellowship
Other areas of specialty/work
Street address
Kargar Ave. Shariati Hospital
City
Tehran
Postal code
14114
Phone
+98 21 8490 2635
Fax
Email
horcbmt@sina.tums.ac.ir
Web page address
http://horcsct.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hematology-Oncology and SCT Research Center
Full name of responsible person
Mahdi Jalili
Position
Clinical Trials Unit secretary / MD
Other areas of specialty/work
Street address
Kargar Ave. Shariati Hospital
City
Tehran
Postal code
14114
Phone
+98 21 8490 2668
Fax
Email
horcsct@yahoo.com
Web page address
http://horcsct.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)