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

Phase 2

• Conditions: Leukemia; Transplantation, Hematopoietic Stem Cell
• Interventions: Drug: Caspofugin based combination therapy

• Registration Number: NCT01501708
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-26
• Study First Submitted QC: 2011-12-26
• Study First Posted: 2011-12-29
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-09
• Last Update Posted: 2016-05-10
• Primary Completion: 2017-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Caspofugin based combination therapy	Caspofugin based combination therapy	Caspofugin based combination therapy: Patients will recieve caspofungin with voriconazole or amphotericin B

Primary Outcome Measures

Name	Time	Method
Favorable response rate	12 weeks

Secondary Outcome Measures

Name	Time	Method
Overall survival	12 weeks, 1 year

Trial Locations

Locations (1)

Blood & Marrow Transplantation Center, RuiJin Hospital; 🇨🇳 Shanghai, China