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

NCT01501708 | Unknown Phase 2

• 1 other identifier: RJH-2011-71
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia; Transplantation, Hematopoietic Stem Cell

Keywords

caspofungin; IFI; allogeneic hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Favorable response rate

  12 weeks

Secondary Outcomes (1)

• Overall survival

  12 weeks, 1 year

Study Arms (1)

Caspofugin based combination therapy

EXPERIMENTAL

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

Drug: Caspofugin based combination therapy

Interventions

Caspofugin based combination therapy DRUG

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.

Also known as: caspofungin + voriconazole or amphotericin B

Caspofugin based combination therapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Blood & Marrow Transplantation Center, RuiJin Hospital

Shanghai, 200025, China

RECRUITING

MeSH Terms

Conditions

Leukemia

Interventions

Caspofungin; Voriconazole; Amphotericin B

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Ling Wang, M.D.

  Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiong HU, M.D.

CONTACT

86-21-64370045; hujiong@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 26, 2011
• First Posted: December 29, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 10, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)