A comparison of early versus standard administration of Anti-Thymocyte Globulin (ATG) on post-transplant outcomes following mismatched (haploidentical) transplantatio

Phase 3

Recruiting

• Conditions: Condition 1: Acute Myeloid Leukemia. Condition 2: Acute lymphoblastic leukemia.; Acute myelomonocytic leukemia; Acute lymphoblastic leukemia [ALL]; C92.5; C91.0

• Registration Number: IRCT20140818018842N20
• Lead Sponsor: Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sci

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 January 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Recipients of haplo-SCT
Myeloablative Conditioning (MAC)
Peripheral blood stem cell (PBSC) source
Age >17

Exclusion Criteria

Second Transplant
Not signing the consent form

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CMV reactivation was defined as positive CMV-DNA in the blood when the copies exceeded 500 copies/ml. Timepoint: weekly interval from transplant until 180 days post transplant. Method of measurement: CMV-DNA with RT-PCR in the blood when the copies exceeded 500 copies/ml.

Secondary Outcome Measures

Name	Time	Method
Acute Graft versus Host Disease. Timepoint: 100 days posttransplantation. Method of measurement: Acute Graft versus Host Disease was evaluated with physical exam, lab test, and biopsy (graded from I to IV).;Chronic Graft versus Host Disease. Timepoint: 1 year post-transplantation. Method of measurement: Physical exam, lab test, and biopsy (graded : limited and extensive).;Relapse incidence. Timepoint: 1 year post-transplantation. Method of measurement: Bone Marrow aspiration and biopsy.;Overall survival. Timepoint: One-year post-transplantation. Method of measurement: Follow-up.;Disease-free survival. Timepoint: One-year post-transplantation. Method of measurement: Follow-up, Bone Marrow aspiration and biopsy,.;Graft versus Host Disease-free relapse-free survival. Timepoint: One-year post-transplantation. Method of measurement: Follow-up, Bone Marrow aspiration and biopsy, lab test.