Back to resultsCaspofungin Based Combined Anti-fungal Therapy for Proven or Probable Invasive Fungal Infection
Primary Purpose
Leukemia, Transplantation, Hematopoietic Stem Cell
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Caspofugin based combination therapy
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring caspofungin, IFI, allogeneic hematopoietic stem cell transplantation
Eligibility 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
Sites / Locations
- Blood & Marrow Transplantation Center, RuiJin HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Caspofugin based combination therapy
Arm Description
Caspofugin based combination therapy: Patients will recieve caspofungin with voriconazole or amphotericin B
Outcomes
Primary Outcome Measures
Favorable response rate
Secondary Outcome Measures
Overall survival
Full Information
NCT ID
NCT01501708
First Posted
December 26, 2011
Last Updated
May 9, 2016
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01501708
Brief Title
Caspofungin Based Combined Anti-fungal Therapy for Proven or Probable Invasive Fungal Infection
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 Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
Patients will recieve caspofungin with either voriconazole or amphotericin B as combination therapy for fungal infection
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Transplantation, Hematopoietic Stem Cell
Keywords
caspofungin, IFI, allogeneic hematopoietic stem cell transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Caspofugin based combination therapy
Arm Type
Experimental
Arm Description
Caspofugin based combination therapy:
Patients will recieve caspofungin with voriconazole or amphotericin B
Intervention Type
Drug
Intervention Name(s)
Caspofugin based combination therapy
Other Intervention Name(s)
caspofungin + voriconazole or amphotericin B
Intervention Description
Caspofungin: 70 mg on the first day of therapy, followed by 50 mg q.d.
All patients received azoles as prophylaxis (fluconazole as prophylaxis and itraconazole or voriconazole as secondary prophylaxis), combination with liposomal amphotericin B at a dosage 3mg/kg q.d will be given.
In case of renal function damage, combination with voriconazole 6mg/kg followed by 4 mg/kg b.i.d. will be given.
Primary Outcome Measure Information:
Title
Favorable response rate
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
12 weeks, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiong HU, M.D.
Phone
86-21-64370045
Ext
601818
Email
hujiong@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ling Wang, M.D.
Organizational Affiliation
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blood & Marrow Transplantation Center, RuiJin Hospital
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Wang, M.D
Phone
86-21-64370045
Ext
601818
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Caspofungin Based Combined Anti-fungal Therapy for Proven or Probable Invasive Fungal Infection
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