UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 2 study of ATRA and arsenic trioxide for acute promyelocytic leukemia
Title of the study (Brief title)	Phase 2 study of ATRA and arsenic trioxide for acute promyelocytic leukemia
Region	Japan

Condition
Condition	acute promyelocytic leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of all-trans retinoic acid (ATRA) and arsenic trioxide for acute promylocytic leukemia (APL)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Complete remission rate (CR)
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	all-trans retinoic acid idarubicin arsenic trioxide
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Newly diagnosed APL (FAB: M3 or M3v) 2. Performance status (ECOG): 0-2 3. Adequate cardiac, pulmonary, hepatic and renal function 4. Written informed consent
Key exclusion criteria	1. Severe co-morbidity 2. Pregnant and/or lactating woman 3. Patients who have a difficulty to enter the study.
Target sample size	45

Research contact person
Name of lead principal investigator	Tatsuo Ichinohe
Organization	Hiroshima University Hospital
Division name	Department of Hematology
Address	1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553, JAPAN
TEL	082-257-5861
Email	nohe@hiroshima-u.ac.jp

Public contact
Name of contact person	Jun Imagawa
Organization	Hiroshima University Hospital
Division name	Department of Hematology
Address	1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553, JAPAN
TEL	082-257-5861
Homepage URL
Email	imagawa@hiroshima-u.ac.jp

Sponsor
Institute	Department of Hematology, Hiroshima University Hospital
Institute
Department

Funding Source
Organization	Department of Hematology and Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University
Organization
Division
Category of Funding Organization	Other
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	2013 Year 10 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 30 Day
Anticipated trial start date	2013 Year 09 Month 01 Day
Last follow-up date	2017 Year 09 Month 30 Day
Date of closure to data entry	2017 Year 09 Month 30 Day
Date trial data considered complete	2017 Year 09 Month 30 Day
Date analysis concluded	2017 Year 09 Month 30 Day

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

Management information
Registered date	2013 Year 10 Month 09 Day
Last modified on	2018 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013271