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IRCT20140818018842N19 IRCT 2020-08-16 Tehran University of Medical Sciences NAC for prevention of PGF and PT in Haploidentical HSCT 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 2020-08-10 anticipated 20 Complete https://irct.ir/trial/48829 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Condition 1: Acute myeloblastic leukemia. Condition 2: Acute lymphoblastic leukemia. Intervention 1: 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). Intervention 2: 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). Yes - There is a plan to make this available What will be shared: IPD collected for the primary outcome measure only When: immediate after publication To whom: no body Conditions: after research committee confirmation Where to obtain: Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sciences, ctu@tums.ac.ir How to obtain: not provided Comments:
public Maryam Barkhordar
Shariati Hospital, Kaargar shomali Ave.
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8800 4140 mbarkhordar@sina.tums.ac.ir Tehran University of Medical Sciences scientific Maryam Barkhordar
Shariati Hospital, Kaargar shomali Ave.
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8800 4140 mbarkhordar@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) patients aged 18 to 55 years diagnosed with acute leukemia complete remission scheduled to receive haplo-HSCT 18 years 55 years Both Bronchial asthma NAC allergy Intolerance to oral drug C92.0 C91.02 Acute myeloblastic leukemia Acute lymphoblastic leukemia, in relapse Treatment - Drugs Treatment - Other 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) 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) Prolonged isolated thrombocytopenia (PT). Timepoint: 60 days after HSCT. Method of measurement: Complete Blood Count (CBC), Bone Marrow Biopsy (BMB), Bone Marrow Aspiration (BMA). Poor Graft Function. Timepoint: 60 days after HSCT. Method of measurement: Complete Blood Count (CBC), Bone Marrow Biopsy (BMB), Bone Marrow Aspiration (BMA). Cumulative incidence acute GvHD. Timepoint: After 100 daye post HSCT. Method of measurement: Physical exam and lab test. Cumulative incidence Relaps. Timepoint: َAfter 1 year post HSCT. Method of measurement: Bone Marrow aspiration and biopsy. Cumulative incidence TRM. Timepoint: After 100 daye post HSCT. Method of measurement: ّّFollow up visit to check relaps or death. 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. One year overal survival (OS). Timepoint: after 100 day post HSCT. Method of measurement: Follow up visit. Tehran University of Medical Sciences Approved 2020-01-08 Hematology , Oncology and Stem Cell Transplantation Research Center- Tehran University of Medical Sc Shariati Hospital, Kargar shomali Ave., Tehran Tehran Tehran Iran (Islamic Republic of)