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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014