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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


Phase 2
18 Years
55 Years
Open (Enrolling)
Both
Leukemia,, Allogeneic Hematopoietic Stem Cell Transplantation

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Favorable response rate

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Ling Wang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

Authority:

China: Ethics Committee

Study ID:

RJH-2011-71

NCT ID:

NCT01501708

Start Date:

December 2011

Completion Date:

June 2014

Related Keywords:

  • Leukemia,
  • ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION
  • caspofungin
  • IFI
  • allogenei hematopoietic stem cell transplantation
  • Leukemia
  • Mycoses

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