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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140818018842N19

Enrollment

Registered

2020-08-16

Start date

2020-08-10

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Acute myeloblastic leukemia. Condition 2: Acute lymphoblastic leukemia. Acute myeloblastic leukemia Acute lymphoblastic leukemia, in relapse

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: patients aged 18 to 55 years diagnosed with acute leukemia complete remission scheduled to receive haplo-HSCT

Exclusion criteria

Exclusion criteria: Bronchial asthma NAC allergy Intolerance to oral drug

Design outcomes

Primary

Measure	Time frame
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).	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Barkhordar

Tehran University of Medical Sciences

mbarkhordar@sina.tums.ac.ir+98 21 8800 4140

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026