Caspofungin Based Combined Anti-fungal Therapy for Proven or Probable Invasive Fungal Infection

Study Overview
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Brief Summary
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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
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Patients will recieve caspofungin with either voriconazole or amphotericin B as combination therapy for fungal infection

Official Title
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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

Conditions
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Leukemia, Transplantation, Hematopoietic Stem Cell

Intervention / Treatment
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* Drug: Caspofugin based combination therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caspofugin based combination therapy<br>Caspofugin based combination therapy: Patients will recieve caspofungin with voriconazole or amphotericin B | Drug: Caspofugin based combination therapy<br>* 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.<br>* Other names: caspofungin + voriconazole or amphotericin B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Favorable response rate |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 12 weeks, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caspofungin, IFI, allogeneic hematopoietic stem cell transplantation