AC for prevention of PGF and PT in Haploidentical HSCT

Phase 3

• Conditions: Condition 1: Acute myeloblastic leukemia. Condition 2: Acute lymphoblastic leukemia.; Acute lymphoblastic leukemia, in relapse; C91.02; C92.0; Acute myeloblastic leukemia

• Registration Number: IRCT20140818018842N19
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.