Hematological malignancies
Conditions
Interventions
Alemtuzumab is added to the TBI-based or fludarabine-based regimens at 0.16 –
0.25 mg/kg per day for 6 days (days -8 to -3).
Sponsors
GCP-ISS HE0402 group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Disease (a) Acute myelogenous leukemia(AML)  Refractory case (other than CR1)  AML secondry to MDS (including CR1) (b) Acute lymphocytic leukemia (ALL)  Refractory case (other than CR1)  Patients who did not achieve CR within 50 days after the initiation of the therapy.  Philadelphia-positive ALL (including CR1) (a) Chronic myelogenous leukemia (CML)  Advanced case (other than CP1) (b) Myelodysplastic syndrome (MDS)  Neutrophil count below 500/mm3 (for 1 month or longer)  More than 20% blastic cells in bone marrow (c) Malignant lymphoma (ML)  Refractory case  Relapse after autologous transplantation (2) Patients who do not have an available HLA-A/B/DR-matched or 1-locus-mismatched donor in family members. (3) Patients who do not have an HLA-matched unrelated donor or whose disease status precluded time-consuming donor coordination. (4)ECOG performance status of 0 or 1 . (5)Good major organ functions. (6)CD34-positive cells harvested from the donor at least 3.0 x 106 per kg of patient body weight.
Exclusion criteria
Exclusion criteria: (1) Adult T cell leukemia/lymphoma (2) Diabetes uncontrollable even with regular insulin use. (3) Uncontrollable hypertension. (4) Active infection. (5) Refractory hematological malignancies with bone marrow involvement more than 30% of tumor cells. (6) Active central nervous system involvement. (7) Current active double cancer. (8) Women who are or may be pregnant, or who are nursing. (9) Uncontrollable mental illness. (10) Hepatitis B virus antigen-positive (HBsAg or HBeAg). (11) HIV-positive. (12) A history of hypersensitivity to transplant conditioning agents (fludarabine phosphate, busulfan, cyclophosphamide) or agents for GVHD prophylaxis (ciclosporin, methotrexate). (13) A history of hematopoietic stem cell transplantation. However, a single prior autologous transplantation is permitted.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| • Progression-free survival at day 365 • Progression-free mortality at day 365 • Regimen-related toxicity • Incidence of infectious disease • Overall survival at day 365 • Anti-tumor effects | — |
Primary
| Measure | Time frame |
|---|---|
| Survival on day 60 after transplantation Engraftment within 60 days Incidence of grade III to IV acute GVHD within 60 days | — |
Countries
Japan
Contacts
Public ContactYoshinobu Kanda
The University of Tokyo Hospital Department of Hematology & Oncology
Outcome results
None listed