Protocol summary
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Study aim
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evaluation of prophilactic NAC in Poor Graft Function and Prolonged Thrombocytopenia after haploidentical HSCT
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Design
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A Triple-blinded, Randomized, Placebo-controlled phase 3 Trial on 20 patients
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Settings and conduct
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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) or placebo from 7 days pre-HSCT to 30 days post-HSCT (-7 to +30)
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Participants/Inclusion and exclusion criteria
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patients aged 18 to 55 years who were diagnosed with acute leukemia with
complete remission and scheduled to receive haplo-HSCT
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Intervention groups
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Patients who have inclusion criteria after complete informed consent will received oral NAC treatment (400 mg 3 times per day) or placebo from 7 days pre-HSCT to 30 days post-HSCT (-7 to +30)
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Main outcome variables
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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
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Reason for update
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change of control group from historical control group to double blind placebo control
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20140818018842N19
Registration date:
2020-08-16, 1399/05/26
Registration timing:
retrospective
Last update:
2020-11-01, 1399/08/11
Update count:
2
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Registration date
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2020-08-16, 1399/05/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-08-10, 1399/05/20
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Expected recruitment end date
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2020-08-10, 1399/05/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of prophilacticN-Acetylcysteine (NAC) in Poor Graft Function (PGF) and Prolonged Thrombocytopenia (PT) in haploidentical Haematopoietic stem cells transplantation (HSCT) patients: A phase 3, triple-blinded, randomized, placebo-controlled trial
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Public title
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NAC for prevention of PGF and PT in Haploidentical HSCT
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 55 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
20
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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This is a randomized controlled clinical trial with parallel design. We apply balanced block randomization method for randomization. Randomization sequence will be give to a person out of the research team in order to perform concealment.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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NAC and placebo are made in the form of similar tablets by the pharmaceutical company.
Only one person on the study team who is responsible for randomization takes the tables, puts them in similar packages and encodes as a sequence of numbers according to a list of Balanced Block Randomization.
Upon arrival of the each eligible patient, the coded package will be provided with a label that includes the drug numerical code, patient name, and study code. Except for the above person, no body, including the treating physician, the person in charge of data collection and analysis, statistical analyzer, and the patient himself, are aware of the type of drug.
Allocation concealment samples are done by the people of the center that they and patients do not have any information about the researcher's aim.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-01-08, 1398/10/18
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Ethics committee reference number
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IR.TUMS.HORCSCT.REC.1398.001
Health conditions studied
1
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Description of health condition studied
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Acute myeloblastic leukemia
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ICD-10 code
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C92.0
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ICD-10 code description
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Acute myeloblastic leukemia
2
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Description of health condition studied
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Acute lymphoblastic leukemia
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ICD-10 code
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C91.02
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ICD-10 code description
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Acute lymphoblastic leukemia, in relapse
Primary outcomes
1
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Description
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prolonged isolated thrombocytopenia (PT)
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Timepoint
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60 days after HSCT
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Method of measurement
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Complete Blood Count (CBC), Bone Marrow Biopsy (BMB), Bone Marrow Aspiration (BMA)
2
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Description
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Poor Graft Function
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Timepoint
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60 days after HSCT
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Method of measurement
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Complete Blood Count (CBC), Bone Marrow Biopsy (BMB), Bone Marrow Aspiration (BMA)
Secondary outcomes
1
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Description
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Cumulative incidence acute GvHD
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Timepoint
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After 100 daye post HSCT
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Method of measurement
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Physical exam and lab test
2
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Description
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Cumulative incidence Relaps
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Timepoint
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َAfter 1 year post HSCT
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Method of measurement
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Bone Marrow aspiration and biopsy
3
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Description
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Cumulative incidence TRM
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Timepoint
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After 100 daye post HSCT
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Method of measurement
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ّّFollow up visit to check relaps or death
4
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Description
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One year relapse free survival (RFS)
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Timepoint
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After 100 days post HSCT
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Method of measurement
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Bone Marrow aspiration and biopsy, Physical exam and lab test
5
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Description
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One year overal survival (OS)
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Timepoint
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after 100 day post HSCT
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Method of measurement
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Follow up visit
Intervention groups
1
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Description
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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)
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Category
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Treatment - Drugs
2
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Description
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Control group: patients scheduled to receive haplo-HSCT consecutively screened for inclusion in the study and will received placebo 3 times per day from 7 days pre-HSCT to 30 days post-HSCT (-7 to +30)
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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IPD collected for the primary outcome measure only
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When the data will become available and for how long
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immediate after publication
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To whom data/document is available
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no body
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Under which criteria data/document could be used
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after research committee confirmation
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From where data/document is obtainable
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Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sciences,
ctu@tums.ac.ir
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What processes are involved for a request to access data/document
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not provided
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Comments
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