Comparison of post-transplantation high dose cyclophosphamide versus Donor lymphocyte infusion (DLI) as relapse prophylaxis after haploidentical stem cell transplantation in high risk acute leukemia: A prospective randomized study
In this prospective randomized study totally 18 patients aged between 17-50 years, suffered from acute leukemia and candidate for haploidentical stem cell transplantation, are randomized into 2 arms. First arm receive cyclophosphamide 50 mg/kg at day +3 and other arm receive donor lymphocyte infusion (DLI) from donor after subcutaneous granulocyte colony-stimulating factor (G-CSF) at day +30 with average cell dose 4×10^8 mononuclear cells (MNC)/kg (2.5-6×10^8 MNC/kg). Two groups will be compared for rate of relapse, survival and side effect after one year follow up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208041030N11
Registration date:2012-08-26, 1391/06/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-26, 1391/06/05
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 Stem cell Transplantation Research Center
Expected recruitment start date
2009-11-22, 1388/09/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of post-transplantation high dose cyclophosphamide versus Donor lymphocyte infusion (DLI) as relapse prophylaxis after haploidentical stem cell transplantation in high risk acute leukemia: A prospective randomized study
Public title
Prophylaxis of relapse with high dose cyclophosphamide or donor lymphocyte infusion (DLI) after haploidentical stem cell transplantation in high risk acute leukemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of ALL or AML; Status of first complete remission (CR1) in high risk patients and second complete remission (CR2) for others; Age: 17-50; Karnofsky score 70-100; Life expectancy: 12 months; No Full matched donor (Related, Unrelated and Cord Blood); No candidate for autologous transplantation; Live enzyme < 2 upper normal limit (UNL) and Billirubin < 1.5 UNL; Cr < 1.4; Eject fraction (EF) > 45% and Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) greater than 45%; Human Immunodeficiency Virus (HIV) negative; No addiction. Exclusion criteria: Pregnancy; Breast feeding.
Age
From 17 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hematology-Oncology and Stem cell Transplantation Research Center
Street address
Shariati Hospital, Kargar Ave
City
Tehran
Postal code
Approval date
2009-10-08, 1388/07/16
Ethics committee reference number
1388/7/16
Health conditions studied
1
Description of health condition studied
Acute myelblastic leukaemia
ICD-10 code
C92.0
ICD-10 code description
Acute myelblastic leukaemia
2
Description of health condition studied
Acute lymphoblastic leukaemia [ALL]
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukaemia [ALL]
Primary outcomes
1
Description
Relapse rate after transplantation
Timepoint
One year after transplantation
Method of measurement
Bone marrow examination
Secondary outcomes
1
Description
One year overall survival
Timepoint
One year after transplantation
Method of measurement
Examination and following treatment
2
Description
One year disease free survival
Timepoint
One year after transplantation
Method of measurement
Examination and following treatment
3
Description
Rate of chronic GVHD
Timepoint
One year after transplantation
Method of measurement
Examination and following treatment
4
Description
Rate of treatment related mortality
Timepoint
One year after transplantation
Method of measurement
Examination and following treatment
5
Description
Rate of acute GVHD
Timepoint
Three month after transplantation
Method of measurement
Examination and following treatment
Intervention groups
1
Description
Donor lymphocyte infusion (DLI) from donor after subcutaneous granulocyte colony-stimulating factor (G-CSF) at day +30 with average cell dose 4×10^8 mononuclear cells (MNC)/kg (2.5-6×10^8 MNC/kg)
Category
Treatment - Drugs
2
Description
Cyclophosphamide 50 mg/kg at day +3
Category
Treatment - Drugs
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
Hematology-Oncology & SCT Research Center
Full name of responsible person
Dr Kamran Alimoghaddam
Street address
Shariati Hospital, Kargar Ave
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 & 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 & SCT Research Center
Full name of responsible person
Masoud Fakharian
Position
Fellowship of Hematology,Oncology/MD
Other areas of specialty/work
Street address
Shariati Hospital, Kargar Ave
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 & SCT Research Center
Full name of responsible person
Masoud Fakharian
Position
Fellowship of Hematology,Oncology/MD
Other areas of specialty/work
Street address
Shariati Hospital, Kargar Ave.
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 & SCT Research Center
Full name of responsible person
Mahdi Jalili
Position
M.D.
Other areas of specialty/work
Street address
Shariati Hospital, Kargar Ave.
City
Tehran
Postal code
Phone
+98 21 8490 2635
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)