Thymoglobulin for chronic graft-versus-host disease prophylaxis

Anti-thymocyte globulins (Thymoglobulin) for chronic GVHD prophylaxis prior to HLA-matched sibling stem cell transplantation in acute leukemia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0002291

Enrollment

126

Registered

2017-04-04

Start date

2017-04-05

Completion date

Unknown

Last updated

2021-05-24

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 with acute leukemia in CR who sign informed consent will be randomized into ATG arm or no ATG arm (1:1). Patients in ATG arm will be treated with Thymoglobulin (1.25 mg/kg/day, intrave

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 19~65 Complete remission state before transplantation HLA-matched sibling donor Usage of peripheral blood stem cells Eastern Cooperative Oncology Group Performance: 0, 1, 2 Appropriate renal and liver function - Serum creatinine < 2 mg/dl, unless considered due to leukemia - Serum bilirubin < 3 mg/dl, unless considered due to leukemia

Exclusion criteria

Exclusion criteria: uncontrolled significant infection significant renal dysfunction (serum creatinine > 2 mg/dl) significant hepatic dysfunction (serum bilirubin > 3 mg/dl, liver failure, or cirrhosis) Corrected pulmonary diffusion capacity of

Design outcomes

Primary

Measure	Time frame
cumulative incidence of chronic graft-versus-host disease	—

Secondary

Measure	Time frame
cumulative incidence of acute graft-versus-host disease;transplant-related mortality, disease-free survival, overall survival;quality of life after transplantation;adverse effects of Thymoglobulin injection and other complications related with Thymoglobulin;Immune reconstitution and minimal residual disease;discovery of biomarkers (cell, protein, genome including DNA, RNA. etc)	—

Countries

Korea, Republic of

Contacts

Public ContactByung Sik Cho

The Catholic University of Korea

drcbscho@gmail.com+82-2-2258-6072

Outcome results