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

May 9, 2016 updated by: Jiong HU, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200025
        • Recruiting
        • Blood & Marrow Transplantation Center, RuiJin Hospital
        • Contact:
          • Ling Wang, M.D
          • Phone Number: 601818 86-21-64370045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Caspofugin based combination therapy

Caspofugin based combination therapy:

Patients will recieve caspofungin with voriconazole or amphotericin B
Drug: Caspofugin based combination therapy

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.
Other Names:
  • caspofungin + voriconazole or amphotericin B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Favorable response rate
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 12 weeks, 1 year
12 weeks, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Ling Wang, M.D., Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 26, 2011

First Submitted That Met QC Criteria

December 26, 2011

First Posted (Estimate)

December 29, 2011

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 9, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJH-2011-71

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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