Multicenter clinical trial of reduced-intensity conditioning regimen for unrelated bone marrow transplantation with fludarabine, iv busulfan, and low-dose ATG-F
Not Applicable
Recruiting
- Conditions
- Hematologic malignancy
- Registration Number
- JPRN-UMIN000004681
- Lead Sponsor
- ational Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Patients with organ dysfunction as defined below are excluded. (a) EF <40% (b) %VC <30%, FEV1.0% <40%, or PaO2 <50 mmHg or SO2 <90% on room air (c) Serum Cr 2.0 mg/dl or above (d) Serum bilirubin >2.0 mg/dl, ALT(GPT) >3xUNL, chronic active hepatitis, or liver cirrhosis. (2) Uncontrollable hypertension (3) Positive anti-HIV antibody (4) Uncontrollable active infection (5) Uncontrollable CNS disease (6) During pregnancy or breast-feeding (7) Patients with severe psychiatric problems (8) Allergy to drugs for conditioning and GVHD prophylaxis (9) Patients who are considered as ineligible by attending physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Day 100 survival with donor cell engraftment
- Secondary Outcome Measures
Name Time Method 1-year OS and PFS 1-year non-relapse mortality Primary and secondary graft failure Time to neutrophil engraftment and complete chimerism Acute and chronic GVHD Regimen-related toxicity (CTCAE ver 3.0) Relapse or progression Bacterial, fungal, and viral infection Immune reconstitution