A phase II study of antithymocyte globulin in patients undergoing HLA-matched allogeneic peripheral blood stem cell transplantation

A phase II study of antithymocyte globulin in patients undergoing HLA-matched allogeneic peripheral blood stem cell transplantation - JSCT-ATG15

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018645

Enrollment

Registered

2015-10-01

Start date

2015-11-01

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

AML,ALL,HL,NHL

Interventions

1. Conditioning regimen The definition of myeloablative conditioning regimen includes iv Busulfan &gt

7.2 mg/kg or Melphalan &gt

140 mg/m2 or TBI &gt

8 Gy. :Cyclophosphamide (120 mg/kg) + TBI (12Gy/6fr) :iv Busulfan (12.8 mg/kg) + Cyclophosphamide (120 mg/kg) :Fludarabine (120-180 mg/m2) + iv Busulfan (12.8 mg/kg) 2. GVHD prophylaxis Cyclospor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients who have hematologic malignancies as defined at least one of the following: a) Acute Leukemia, CR b) Myelodysplastic syndrome intermediate-II, high as defined by IPSS high, very high as defined by WPSS c) Lymphoma, CR or chemosensitive PR 2.Age: 15-60 years old. 3.Patients who have HLA 8/8 matched related or unrelated peripheral blood stem cell donor 4.Performance status: 0-2 5.Patients with adequate physical function (Cardiac, Hepatic, Renal, Pulmonary). 6.Patients who give written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients who are positive for HIV antibody. 2. Patients with active other malignancies. 3. Patients with active infectious disease. 4. Women who are pregnant, of childbearing potential, or lactating. 5. Patients who experienced serious hypersensitivity or anaphylaxis to antithymocyte globulin. 6. Patients who has a prior history of allogeneic transplantation. 7. Patients who are not eligible for this study at the discretion of the investigator.

Design outcomes

Primary

Measure	Time frame
The incidence of grade III-IV acute GVHD at 100 days	—

Secondary

Measure	Time frame
1. Engraftment at 100 days. 2. The incidence of acute GVHD and chronic GVHD at 100 days, 1 year, and 2 years. 3. Non-relapse mortality at 100 days, 1 year, and 2 years. 4. The incidence of relapse at 100 days, 1 year, and 2 years. 5. Disease-free survival at 100 days, 1 year, and 2 years. 6. Overall survival at 100 days, 1 year, and 2 years. 7. The incidence of infectious event at 100 days, 1 year, and 2 years. 8. GVHD free, relapse free survival (GRFS) at 100 days, 1 year, and 2 years. 9. The proportion of patients who stopped immunosuppressive drugs within 1 year and 2 year. 10. Grade 3-4 non-hematologic toxicity within 100 days. 11. Subgroup analysis subgroup analysis according to conditioning regimen. 12. Subgroup analysis subgroup analysis according to disease risk index (DRI)	—

Measure

Time frame

1. Engraftment at 100 days. 2. The incidence of acute GVHD and chronic GVHD at 100 days, 1 year, and 2 years. 3. Non-relapse mortality at 100 days, 1 year, and 2 years. 4. The incidence of relapse at 100 days, 1 year, and 2 years. 5. Disease-free survival at 100 days, 1 year, and 2 years. 6. Overall survival at 100 days, 1 year, and 2 years. 7. The incidence of infectious event at 100 days, 1 year, and 2 years. 8. GVHD free, relapse free survival (GRFS) at 100 days, 1 year, and 2 years. 9. The proportion of patients who stopped immunosuppressive drugs within 1 year and 2 year. 10. Grade 3-4 non-hematologic toxicity within 100 days. 11. Subgroup analysis subgroup analysis according to conditioning regimen. 12. Subgroup analysis subgroup analysis according to disease risk index (DRI)

—

Countries

Japan

Contacts

Public ContactJunichi Sugita

JSCT ATG15-DC

jsct-office@umin.ac.jp03-6225-2025

Outcome results

None listed

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