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

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01501708
• Other study ID #: RJH-2011-71
• Status: Recruiting
• Phase: Phase 2
• First received: December 26, 2011
• Last updated: May 9, 2016
• Start date: December 2011
• Est. completion date: December 2017

Study information

• Verified date: May 2016
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Jiong HU, M.D.
• Phone: 86-21-64370045
• Email: hujiong[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Mycoses
• Transplantation, Hematopoietic Stem Cell

Intervention

Drug:
• Caspofugin based combination therapy
Caspofungin: 70 mg on the ?rst 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.

Locations

Country	Name	City	State
China	Blood & Marrow Transplantation Center, RuiJin Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Favorable response rate		12 weeks	No
Secondary	Overall survival		12 weeks, 1 year	Yes