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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01501708

Enrollment

Registered

2011-12-29

Start date

2011-12-31

Completion date

2017-12-31

Last updated

2016-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Transplantation, Hematopoietic Stem Cell

Keywords

caspofungin, IFI, allogeneic hematopoietic stem cell transplantation

Brief summary

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.

Detailed description

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

Interventions

DRUGCaspofugin 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
Favorable response rate	12 weeks

Secondary

Measure	Time frame
Overall survival	12 weeks, 1 year

Countries

China

Contacts

Primary ContactJiong HU, M.D.

hujiong@medmail.com.cn86-21-64370045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026