Phase 1 safety trial of bortezomib-based graft-versus-host disease prophylaxis in allogeneic hematopoietic stem cell transplantation from an HLA-mismatched unrelated donor in the Japan marrow donor program (JMDP)
- Conditions
- Adult hematological malignancies who have an indication for allogeneic stem cell transplantation
- Registration Number
- JPRN-UMIN000007723
- Lead Sponsor
- Hematology,Osaka City University, Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 6
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidences of dose-limiting toxicity of high-dose bortezomib (defined as DLT1) and low-dose bortezomib (defined as DLT2)
- Secondary Outcome Measures
Name Time Method