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

This study is currently recruiting participants.
Verified March 2014 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Jiong HU, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01501708
First received: December 26, 2011
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Leukemia,
Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Caspofugin + voriconazole or amphotericin B
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Favorable response rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 12 weeks, 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: December 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caspofugin Drug: Caspofugin + voriconazole or amphotericin B

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501708

Contacts
Contact: Jiong HU, M.D. 86-21-64370045 ext 601818 hujiong@medmail.com.cn

Locations
China
Blood & Marrow Transplantation Center, RuiJin Hospital Recruiting
Shanghai, China, 200025
Contact: Ling Wang, M.D    86-21-64370045 ext 601818      
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Ling Wang, M.D. Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
  More Information

No publications provided

Responsible Party: Jiong HU, M.D., Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01501708     History of Changes
Other Study ID Numbers: RJH-2011-71
Study First Received: December 26, 2011
Last Updated: March 18, 2014
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
caspofungin
IFI
allogenei hematopoietic stem cell transplantation

Additional relevant MeSH terms:
Leukemia
Mycoses
Neoplasms by Histologic Type
Neoplasms
Amphotericin B
Liposomal amphotericin B
Antifungal Agents
Voriconazole
Caspofungin
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014