Adult hematological malignancies who have an indication for allogeneic stem cell transplantation
Conditions
Interventions
Bortezomib is given at day 1, 4 and 7 after transplantation for GVHD prophylaxis. Three dose levels are planned (level 0: 1.0 mg/m2, level1: 1.3 mg/m2 and level2: 1.5 mg/m2) and 1.3mg/m2 (level 1) is
Sponsors
Hematology,Osaka City University, Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Documented informed consent 2. PS 0 or 1 3. Patient with hematological malignancy who have an indication for allogeneic hematopoietic stem cell transplantation but lacks a suitable donor including related HLA-matched, related 1-antigen mismatched and unrelated HLA-matched donor, and both of the following two conditions 3-1 and 3-2 should be met. 3-1: Single antigen mismatch at HLA-A, B, C or DR locus (with 7/8 allele match), or single allele mismatch at HLA-A or B locus (with 7/8 allele match). Only one antigen or one allele mismatch at HLA-C locus except for severe acute GVHD high-risk mismatch combination is excluded. 3-2: One antigen and one allele mismatch at HLA-A, B, C or DR (with 6/8 allele match) except for mismatches at the same locus. 4. Normal function of major organ
Exclusion criteria
Exclusion criteria: 1. Uncontrolled active infection 2. Uncontrolled CNS invasion 3. Poorly controlled insulin-treated diabetes mellitus 4. Poorly controlled hypertension 5. Patients with a severe complication including heart failure, coronary failure, acute myocardial infarction within the last 3 months, liver cirrhosis or interstitial pneumonia 6. Pregnant, nursing or possibly pregnant woman 7. Patients with severe mental disorder who are unlikely to unable to participate in the study due to a severe mental disorder 8. A history of hypersensitivity or allergy to any drugs in the conditioning regimen of this transplant 9. HIV antibody positivity 10. Peripheral neuropathy >= grade2 11. Unable to give methotrexate due to pleural effusion and ascites 12. ATG or Campath-1H containing conditioning regimen 13. Nonmyeloablative conditioning regimens, the dose intensity of which are equal to or less than that of truly mini-conditioning developed in Seattle "TBI2Gy + Fludarabine 90mg/m2" 14. Progression or relapse is expected within day 100 after transplantation 15. Other active malignancy 16. Patients with a donor-specific anti-HLA antibodyies 17. Inappropriate to participate in this study as no indication for this study judged by physician in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidences of dose-limiting toxicity of high-dose bortezomib (defined as DLT1) and low-dose bortezomib (defined as DLT2) | — |
Countries
Japan
Contacts
Public ContactTakahiko Nakane
Osaka City University, Graduate School of Medicine Hematology
Outcome results
None listed