Caspofungin Based Combined Anti-fungal Therapy for Proven or Probable Invasive Fungal Infection
Information source: Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia,; Allogeneic Stem Cell Transplantation
Intervention: Caspofugin based combination therapy (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Shanghai Jiao Tong University School of Medicine Official(s) and/or principal investigator(s):
Ling Wang, M.D., Principal Investigator, Affiliation: Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Overall contact:
Jiong HU, M.D., Phone: 86-21-64370045, Ext: 601818, Email: hujiong@medmail.com.cn
Summary
In this prospective phase II observational study, we plan to assess the efficacy and
tolerability of caspofungin based combined anti-fungal therapy for proven or probable IFI in
a group of patients received allo-HSCT transplantation with high risk of IFI: HLA matched
unrelated donor or mismatched donor conditioning with ATG containing regimen or present
III-IV aGVHD or extensive GVHD undergoing high-dose steroid treatment.
Clinical Details
Official title: 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
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Favorable response rate
Secondary outcome: Overall survival
Detailed description:
Patients will recieve caspofungin with either voriconazole or amphotericin B as combination
therapy for fungal infection
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Jiong HU, M.D., Phone: 86-21-64370045, Ext: 601818, Email: hujiong@medmail.com.cn
Blood & Marrow Transplantation Center, RuiJin Hospital, Shanghai 200025, China; Recruiting
Ling Wang, M.D, Phone: 86-21-64370045, Ext: 601818
Additional Information
Starting date: December 2011
Last updated: May 20, 2015
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