Evaluation of prophilactic NAC in Poor Graft Function and Prolonged Thrombocytopenia in haploidentical HSCT patients l: A phase 3 historical control clinical trial
evaluation of prophilactic NAC in Poor Graft Function and Prolonged Thrombocytopenia after haploidentical HSCT
Design
A phase 3 historical controlled clinical trial with 44 patients
Settings and conduct
Patients who have inclusion criteria that have admitted in HSCT wards of Shariati hospital will received oral NAC treatment (400 mg 3 times per day) from 7 days pre-HSCT to 30 days post-HSCT (-7 to +30)
Participants/Inclusion and exclusion criteria
patients aged 18 to 55 years who were diagnosed with acute leukemia with
complete remission and scheduled to receive haplo-HSCT
Intervention groups
Patients who have inclusion criteria after complete informed consent will received oral NAC treatment (400 mg 3 times per day) from 7 days pre-HSCT to 30 days post-HSCT (-7 to +30)
Main outcome variables
Cumulative incidence of poor graft function (PGF) and prolonged isolated thrombocytopenia (PT) after 2 mounts post HSCT; Cumulative incidence acute GvHD after 100 daye post HSCT; Cumulative incidence Relaps after 1 year post HSCT; Cumulative incidence TRM after 1 year post HSCT; One year relaps free survival (RFS) ; One year overal survival (OS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140818018842N19
Registration date:2020-08-16, 1399/05/26
Registration timing:retrospective
Last update:2020-08-16, 1399/05/26
Update count:2
Registration date
2020-08-16, 1399/05/26
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 3691
Email address
ctu@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-10, 1399/05/20
Expected recruitment end date
2020-08-10, 1399/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of prophilactic NAC in Poor Graft Function and Prolonged Thrombocytopenia in haploidentical HSCT patients l: A phase 3 historical control clinical trial
Public title
NAC for prevention of PGF and PT in Haploidentical HSCT
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients aged 18 to 55 years
diagnosed with acute leukemia
complete remission
scheduled to receive haplo-HSCT
Exclusion criteria:
Bronchial asthma
NAC allergy
Intolerance to oral drug
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Historical Control Studies
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hematology , Oncology and Stem Cell Transplantation Research Center- Tehran University of Medical Sc
Street address
Shariati Hospital, Kargar shomali Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2020-01-08, 1398/10/18
Ethics committee reference number
IR.TUMS.HORCSCT.REC.1398.001
Health conditions studied
1
Description of health condition studied
Acute myeloblastic leukemia
ICD-10 code
C92.0
ICD-10 code description
Acute myeloblastic leukemia
2
Description of health condition studied
Acute lymphoblastic leukemia
ICD-10 code
C91.02
ICD-10 code description
Acute lymphoblastic leukemia, in relapse
Primary outcomes
1
Description
prolonged isolated thrombocytopenia (PT)
Timepoint
60 days after HSCT
Method of measurement
Complete Blood Count (CBC), Bone Marrow Biopsy (BMB), Bone Marrow Aspiration (BMA)
2
Description
Poor Graft Function
Timepoint
60 days after HSCT
Method of measurement
Complete Blood Count (CBC), Bone Marrow Biopsy (BMB), Bone Marrow Aspiration (BMA)
Secondary outcomes
1
Description
Cumulative incidence acute GvHD
Timepoint
After 100 daye post HSCT
Method of measurement
Physical exam and lab test
2
Description
Cumulative incidence Relaps
Timepoint
َAfter 1 year post HSCT
Method of measurement
Bone Marrow aspiration and biopsy
3
Description
Cumulative incidence TRM
Timepoint
After 100 daye post HSCT
Method of measurement
ّّFollow up visit to check relaps or death
4
Description
One year relapse free survival (RFS)
Timepoint
After 100 days post HSCT
Method of measurement
Bone Marrow aspiration and biopsy, Physical exam and lab test
5
Description
One year overal survival (OS)
Timepoint
after 100 day post HSCT
Method of measurement
Follow up visit
Intervention groups
1
Description
Intervention group: patients scheduled to receive haplo-HSCT consecutively screened for inclusion in the study and will received oral NAC ( tablet 200mg), 400 mg 3 times per day(total dose 1200 mg) from 7 days pre-HSCT to 30 days post-HSCT (-7 to +30)
Category
Treatment - Drugs
2
Description
Control group: all patients who underwent haploidentical HSCT from 2014 to 2020 with standard hoplo protocol in our center is defined as a historical control group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sci
Full name of responsible person
Maryam Barkhordar
Street address
Shariati hospital, Kargar shomali Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 4140
Email
mbarkhordar@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seied Asadollah Mousavi
Street address
Shariati hospital, Kargar shomali Ave
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+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?
Yes
Title of funding source
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
Maryam Barkhordar
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Shariati Hospital, Kaargar shomali Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 4140
Email
mbarkhordar@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Barkhordar
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Shariati Hospital, Kaargar shomali Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 4140
Email
mbarkhordar@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leyla sharifi Aliabadi
Position
Research Assistant
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shariati Hospital, Kargar shomali Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 4140
Email
ctu@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
IPD collected for the primary outcome measure only
When the data will become available and for how long
immediate after publication
To whom data/document is available
no body
Under which criteria data/document could be used
after research committee confirmation
From where data/document is obtainable
Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sciences,
ctu@tums.ac.ir
What processes are involved for a request to access data/document