Trial Information
Phase II Study of Caspofungin Based Combined Anti-fungal Therapy for Patients With Proven or Probable Invasive Fungal Infection After Allogeneic Stem Cell Transplantation From HLA-matched Unrelated or HLA-mismatched Related Donors
Inclusion Criteria:
- adult patient undergoing allogeneic hematopoietic stem cell transplantation
- age 18-55 years
- with inform consent
- no contraindication for allogeneic transplantation: active infection, allergy to
FLu/Bu/CTX, liver and renal function damage
- HLA mismatched related (3~5/6) or unrelated donors (at least 8/10)
- proven or probable IFI
Exclusion Criteria:
- age less than 18 years or over 56 years
- HLA mismatched related donor
- liver function/renal function damage (over 2 X upper normal range)
- with mental disease
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Favorable response rate
Outcome Time Frame:
12 weeks
Safety Issue:
No
Principal Investigator
Ling Wang, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Authority:
China: Ethics Committee
Study ID:
RJH-2011-71
NCT ID:
NCT01501708
Start Date:
December 2011
Completion Date:
June 2014
Related Keywords:
- Leukemia,
- ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION
- caspofungin
- IFI
- allogenei hematopoietic stem cell transplantation
- Leukemia
- Mycoses