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A multicenter pilot study of antithymocyte globulin in patients undergoing allogeneic peripheral blood stem cell transplantation

A multicenter pilot study of antithymocyte globulin in patients undergoing allogeneic peripheral blood stem cell transplantation - NJHSG-ATG

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017170
Enrollment
6
Registered
2015-04-19
Start date
2013-11-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

hematological malignancies

Interventions

Thymoglobulin (rabbit ATG), 1mg/kg, day-2, -1

Sponsors

North Japan Hematology Study Group (NJHSG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who are eligible for allogeneic stem cell transplantation (a) acute leukemia: CR1 or CR2 (b) lymphoma: PR or CR (c) MDS: IPSS int-2 or high; WPSS high or very high 2. Age: 16-65 years old 3. Patients who have HLA-matched related or unrelated PBSCT donor 4. Donor age: 12-65 years old 5. Performance status: 0-2 6. Patients with adequate physical function (Cardiac, Hepatic, Renal, Pulmonary).

Exclusion criteria

Exclusion criteria: 1. Patients who are positive for HBs antigen or HIV antibody. 2. Patients with severe mental illness 3. Women who are pregnant, of childbearing potential, or lactating. 4. Patients with active other malignancies. 5. Patients with active infectious disease. 6. Patients who had a history of myocardial infarction, or who needed treatment for heart failure within 1 year. 7. Patients with cirrhosis 8. Obese patients (body mass index [BMI; 35 or greater]) 9. Patients with arrhythmia (CTCAE Grade 3 or more) 10. Patients who experienced serious hypersensitivity or anaphylaxis to antithymocyte globulin. 11. Patients who are not eligible for this study at the discretion of the investigator.

Design outcomes

Primary

MeasureTime frame
the incidences of CMV infection, hemorrhagic cystitis, and PTLD at 1 year

Countries

Japan

Contacts

Public ContactSugita Junichi

Hokkaido University Hospital Department of Hematology

sugitaj@med.hokudai.ac.jp011-706-7214

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026