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

S

Shanghai Jiao Tong University School of Medicine

Status and phase

Unknown
Phase 2

Conditions

Leukemia
Transplantation, Hematopoietic Stem Cell

Treatments

Drug: Caspofugin based combination therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01501708
RJH-2011-71

Details and patient eligibility

About

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.

Full description

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

Enrollment

55 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

55 participants in 1 patient group

Caspofugin based combination therapy
Experimental group
Description:
Caspofugin based combination therapy: Patients will recieve caspofungin with voriconazole or amphotericin B
Treatment:
Drug: Caspofugin based combination therapy

Trial contacts and locations

1

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Central trial contact

Jiong HU, M.D.

Data sourced from clinicaltrials.gov

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