UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of liposomal amphotericin B for febrile neutropenia.(C-SHOT1001)
Title of the study (Brief title)	L-AMB for FN.(C-SHOT1001)
Region	Japan

Condition
Condition	Hematological malignancies
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To make clear the effectiveness of empirical therapy of L-AMB for febrile neutropenia in patients with haematological malignancies.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	*Keeping up body temperature under 38degrees celcius for 48 hours. *No invasive fungal infection *No change of antifungal agents *No interruption of treatment due to adverse reactions *Patient survival
Key secondary outcomes	*Frequencies of adverse reactions *Alleviation of fever *The therapy finished.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Empirical therapy of L-AMB
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with haematological malignancies accompanied by febrile neutropenia who do not respond to antibiotics. Age ranging from 16 to 79.
Key exclusion criteria	(1) Allergy to L-AMB (2) Infection with proven pathogens (3) HIV-antibody positive (4) Pregnant or lactating patients (5) Patients after allogeneic stem cell transplantation (6) Invasive fungal infections (7) Those considered inappropriate to be participated
Target sample size	80

Research contact person
Name of lead principal investigator	Nobuhiko Emi
Organization	Fujita Health University
Division name	Department of Hematology
Address	1-9-8 Dengakugakubo Kutsukake-cho Toyoake Aichi
TEL	0562-93-2000
Email

Public contact
Name of contact person	Masashi Sawa
Organization	Anjo Kosei Hospital
Division name	Department hematology and oncology
Address	28 Higashihirokute Anjo-cho Anjo Aichi
TEL	0566-75-2111
Homepage URL
Email	support@c-shot.or.jp

Sponsor
Institute	Center for Supporting Hematology-Oncology Trials
Institute
Department

Funding Source
Organization	Center for Supporting Hematology-Oncology Trials
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2010 Year 02 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 03 Month 11 Day
Anticipated trial start date	2010 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 02 Month 15 Day
Last modified on	2016 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003849