Aplastic anemia
Conditions
Interventions
Alemtuzumab is added to the fludarabine-based regimen at 0.16 –
0.25 mg/kg per day for 6 days (days -10 to -5).
Sponsors
GCP-ISS HE0403 group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with transfusion-dependent moderately severe, severe or very severe acquired aplastic anemia persisting for 6 months or longer after immunosuppressant treatment with ATG alone or in combination with cyclospoline. (2) Patients who have an HLA-matched or 1-locus-mismatched related donor or an HLA-matched unrelated donor. (3) ECOG performance status of 0 or 1. (4) Good major organ functions.
Exclusion criteria
Exclusion criteria: (1) Diabetes uncontrollable even with regular insulin use. (2) Uncontrollable hypertension. (3) Current active infection. (4) 5% or more malignant cell involvement in bone marrow. (5) Abnormality in chromosome 7 detected by bone marrow G-banding or FISH. (6) Current active cancer. (7) Pregnant or nursing women or women who may be pregnant. (8) Uncontrollable mental illness. (9) Hepatitis B virus antigen-positive (HBsAg or HBeAg). (10) HIV-positive. (11) A history of hypersensitivity to transplant conditioning agents (fludarabine phosphate, cyclophosphamide) or agents for GVHD prophylaxis (ciclosporin, methotrexate). (12) A history of hematopoietic stem cell transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival on day 60 after transplantation Engraftment within 60 days Incidence of grade II to IV acute GVHD within 60 days | — |
Secondary
| Measure | Time frame |
|---|---|
| • Regimen-related toxicity • Incidence of infectious disease • Overall survival at day 365 • Therapeutic efficacy for aplastic anemia | — |
Countries
Japan
Contacts
Public ContactYoshinobu Kanda
The University of Tokyo Hospital Department of Hematology & Oncology
Outcome results
None listed