hematological malignancies
Conditions
Interventions
Patients will take oligopeptide from the beginning of conditioning regimen and up to 21 days after transplantation
Patients in non-oligopeptide group will not take oligopeptide
Sponsors
Research supported by Ministry of Health, Labour and Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patient with hematological malignancy which has the indication for the allogeneic transplant. (2) Patient who receives an unrelated stem cell source (3) Patient who can take oligopeptide (4) Age from 18 to 70 (5) ECOG PS 0 or 1 (6) Patient who cannot tolerate myeloablative conditioning regimen (7) Patient who had the informed consent (8) Patient who expects to survive longer than 3 months
Exclusion criteria
Exclusion criteria: (1) Patient with severe organ dysfunction (2) Patient with the postitivity of anti-HIV antibody (3) Patient with uncontrolled infection (4) Patient with pregnancy or breast feeding (5) Patient with pshycological disease (6) Patient with allergy against the drugs which are used for allogeneic transplant including chemotherapy and GVHD prophylaxis (7) Patient with allergy against oligopeptide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Probability of more than grade 3 intestinal toxicity up to 28 days after transplant | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) 1-year overall survival and 1-year progression-free survival (2) Total duration of more than grade 3 intestinal toxicity up to 28 days (3) Treatment-related toxicity (4) Engraftment (5) Acute GVHD (6) Infection (7) Duration of TPN (8) Dose and duration of intravenous molphine (9) Total dose of insulin (10) Hyperglycemia and hypoglycemia (11) DAO activity (12) Laboratory data (total protein, albumin, cholinesterase, pre-albumin, RBP, CRP, urinary creatinine) | — |
Countries
Japan
Contacts
Public ContactSung-Won Kim
National Cancer Center Hospital Department of hematology
Outcome results
None listed