Hematological diseases
Conditions
Interventions
3.2mg/kg of IvBu will be administered intravenously for 3 hours once-daily.
Sponsors
Toranomon Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who are suffering from hematological diseases (acute leukemia, myelodysplastic syndrome, chronic myeloid leukemia, myeloproliferative disorders, malignant lymphoma), and who need allogeneic hematopoietic stem cell transplantation. (2) Patients who have appropriate donors available (related, unrelated donor, cord blood donor). (3) Patients who gave written informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients who have active malignant diseases other than hematological diseases (2) Patients who have poorly controlled psychiatric diseases (3) Patients who have active infection (4) Patients who have history of hypersensitivity against ivBu (5) Patients who are pregnant or suspected pregnancy, or are lactating (6) Patients who are considered to be not appropriate candidates for participation by attending physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Incidence of survival and donor cell engraftment at day 100 post-transplant (2) Incidence of achieving complete donor type chimerism at day 100 post transplant (3) Event-free survival rate at day 365 post-transplant (4) Overall survival rate at day 365 post-transplant (5) Incidences of acute or chronic GVHD up to day 365 post-transplant | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Incidence of adverse events up to day 100 post-transplant (2) Non-relapse mortality rate at day 100 post-transplant (3) Incidence of sinusoidal obstruction syndrome up to day 100 post-transplant (4) Rate of achieving optimal ivBu AUC (3,600-6,000micromolxmin/ml) | — |
Countries
Japan
Contacts
Public ContactNaoyuki Uchida
Toranomon Hospital Department of Hematology
Outcome results
None listed