hematologic malignancies relapesd after allogeneic stem cell transplantation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: cases with hematologic malignancies relapsed after allogeneic stem cell transplantation who fulfill the following (patient and spousal donor), [patient] 1) Written informed consent 2) no expectancy of cure with standard therapies including DLI [family donor] 1) healthy family member who desires to become the donor 2) no available or suitable donor in unrelate bank, cord blood bank, haploidentical relatives (confirmed by our conference) 3) If there is an aveilable spousal donor, the patient and the family can participate either in this protocol or in spousal transplantation protocol (spousal hematopoietic stem cell transplantation for posttransplant relapse UMIN000004132).
Exclusion criteria
Exclusion criteria: 1) Cre > 2.0 mg/dl 2) EF < 40% 3) T-Bil > 2.0 mg/dl 4) AST and/or ALT > 200 U/L 5) SpO2 < 90% (room air) 6) PS (ECOG score) 3-4 Patients with these data due to original diseases are not excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of donor cell engraftment (>90% of donor origin) on day 35 | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Incidence and severity of chronic GVHD b) transplantion-associated complications, especially TMA c) relapse rate within three months | — |
Countries
Japan
Contacts
Hyogo College of Medicine Division of Hematology, Department of Internal Medicine