A phase II study of posttransplantation cyclophosphamide in patients undergoing HLA 6-8/8 match transplantation (JSCT PTCY19)
- Conditions
- hematologic malignancies
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 44
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, or high, very high as defined by WPSS
c) Lymphoma: CR or chemosensitive PR
2.Age: 20-65 years old.
3.Patients who have HLA 6-8/8 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.
- Patients with active other malignancies or patients with a history of malignancies within 5 years
- Patients with active infectious disease.
- Women who are pregnant or lactating
- Patients who experienced serious hypersensitivity or anaphylaxis to cyclophosphamide, tacrolimus, mycophenolate mofetil.
- Patients who have positive anti-donor HLA antibody.
- Patients who are not eligible for this study at the discretion of the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method - The incidence of grade III-IV acute GVHD at 100 days
- Secondary Outcome Measures
Name Time Method Engraftment 100 days Engraftment at 100 days.
Overall survival 100 days, 1 year, and 2 years Overall survival at 100 days, 1 year, and 2 years.
Incidence of infectious event 100 days, 1 year, and 2 years The incidence of infectious event at 100 days, 1 year, and 2 years.
Incidence of acute GVHD and chronic GVHD 100 days, 1 year, and 2 years The incidence of acute GVHD and chronic GVHD at 100 days, 1 year, and 2 years.
Incidence of relapse 100 days, 1 year, and 2 years The incidence of relapse at 100 days, 1 year, and 2 years.
Non-relapse mortality 100 days, 1 year, and 2 years Non-relapse mortality at 100 days, 1 year, and 2 years.
Proportion of patients who stopped immunosuppressive drugs 1 year and 2 year The proportion of patients who stopped immunosuppressive drugs within 1 year and 2 year.
Noninfectious fever 7 days after transplantation Noninfectious fever within 7 days after transplantation.
Disease-free survival 100 days, 1 year, and 2 years Disease-free survival at 100 days, 1 year, and 2 years.
GVHD free, relapse free survival (GRFS) 100 days, 1 year, and 2 years GVHD free, relapse free survival (GRFS) at 100 days, 1 year, and 2 years.
Grade 3-4 non-hematologic toxicity 100 days Grade 3-4 non-hematologic toxicity within 100 days.
Subgroup analysis according to conditioning regimen Subgroup analysis according to conditioning regimen.
Subgroup analysis according to disease risk index (DRI) Subgroup analysis according to disease risk index (DRI).