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Comparison of anti-thymocyte globulin (ATG) and post-transplant cyclophosphamide (PTCY) for the prevention of graft-versus-host disease in allogeneic hematopoietic stem cell transplant patients who achieved complete remission after induction therapy for acute myeloid leukemia

Comparison of anti-thymocyte globulin (ATG) and post-transplant cyclophosphamide (PTCY) for the prevention of graft-versus-host disease in allogeneic hematopoietic stem cell transplant patients who achieved complete remission after induction therapy for acute myeloid leukemia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CRIS
Registry ID
KCT0009953
Enrollment
153
Registered
2024-11-27
Start date
2024-12-31
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

None listed

Interventions

Drug : Patients who consented to participate in the study were randomly assigned to either the ATG group or the PTCY group. Randomization was done in a permuted block design with a pre-assigned block

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Selection criteria • Patients aged 18 years or older • Patients with adequate liver and renal function who meet the following conditions - AST, ALT, and direct bilirubin < 2.5 x upper limit of normal - Serum creatinine < 2.0 mg/dL and creatinine clearance = 40 mL/min) • Patients who agreed to participate in the study

Exclusion criteria

Exclusion criteria: Exclusion criteria • Patients with a history of allogeneic hematopoietic stem cell transplantation or autologous hematopoietic stem cell transplantation for leukemia or other malignant tumors • Blast crisis of chronic myeloid leukemia • Patients with a history of other active malignancies within 5 years prior to clinical trial participation, excluding past or current curatively treated basal cell skin cancer or past cervical intraepithelial carcinoma • Patients with uncontrolled infections • Women of childbearing potential, pregnant women, or lactating women who do not wish to use adequate contraception • Patients who, in the investigator's judgment, may pose a risk to patient safety

Design outcomes

Primary

MeasureTime frame
Incidence of Acute Graft-versus-Host Disease;Incidence of Chronic Graft-versus-Host Disease;Cumulative incidence of Acute Graft-versus-Host Disease;Cumulative incidence of Chronic Graft-versus-Host Disease;Leukocyte engraftment date;Platelet engraftment date;Complete donor chimerism attainment rate;CMV, EBV reactivation rate;Total number of repeat calls;Recurrence-free survival rate;Overall survival rate

Secondary

MeasureTime frame
hematologic relapse;Molecular recurrence

Countries

Korea, Republic of

Contacts

Public ContactKyung-Hwa Lee

Asan Medical Center

toyn79@naver.com+82-2-3010-7292

Outcome results

None listed

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