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

A comparison of early versus standard administration of Anti-Thymocyte Globulin (ATG) affecting post-transplant outcomes following haploidentical transplantation with high-dose post-transplant cyclophosphamide: A Randomized Clinical Trial in Phase 3

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140818018842N20

Enrollment

Registered

2021-12-22

Start date

2021-11-17

Completion date

Unknown

Last updated

2022-01-11

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

Conditions

Condition 1: Acute Myeloid Leukemia. Condition 2: Acute lymphoblastic leukemia. Acute myelomonocytic leukemia Acute lymphoblastic leukemia [ALL]

Interventions

The intervention group (arm A) will give rabbit ATG (Thymoglobulin

Genzyme, France) 2.5 mg/kg i.v. (for three consecutive days) started from 9 days before transplantation till 7 days before transplant (on days -9, -8, -7 before transplantation.

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Second Transplant Not signing the consent form

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Barkhordar

Tehran University of Medical Sciences

barkhordarm.n@gmail.com+98 21 8490 2639

Outcome results

None listed

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