UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled Phase 3 trial of all-trans retinoic acid(ATRA) versus new synthetic retinoid Tamibarotene(Am80) for maintenance therapy in patients with adult acute promyelocytic leukemia: Japan Adult Leukemia Study Group (JALSG) APL204 Study
Acronym	Randomized controlled Phase 3 trial of maintenance therapy in patients with adult acute promyelocytic leukemia (JALSG APL204 Study)
Scientific Title	Randomized controlled Phase 3 trial of all-trans retinoic acid(ATRA) versus new synthetic retinoid Tamibarotene(Am80) for maintenance therapy in patients with adult acute promyelocytic leukemia: Japan Adult Leukemia Study Group (JALSG) APL204 Study
Scientific Title:Acronym	Randomized controlled Phase 3 trial of maintenance therapy in patients with adult acute promyelocytic leukemia (JALSG APL204 Study)
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 the new synthetic retinoid Tamibarotene(Am80) compared to all-trans retinoic acid(ATRA) in the maintenance therapy of adult acute promyelocytic leukemia(between the age of 15 to 70) in first complete remission. Study design is multicenter prospective randomized Phase3 trial and primary endpoint is relapse free survival at the time of hematological or molecular relapse in maintenance therapy period. Molecular relapse is defined as over 100copies/microgram RNA of PML/RAR alfa mRNA by real time RT-PCR method.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Primary endpoint is relapse free survival at the time of hematological or molecular relapse in maintenance therapy period.
Key secondary outcomes	Secondary endpoints include complete remission rate, event free survival(EFS), overall survival(OS) and frequency of adverse effects.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	All-trans retinoic acid(ATRA) in maintenace therapy. Patients number requires 120.
Interventions/Control_2	Tamibarotene(Am80) in maintenance therapy. Patients number requires 120
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	15 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Eligibility criteria are as follows, all criteria should be necessary for registration of the study. 1) Patient are informed for APL. 2) Previously untreated APL. MDS derived or atypical leukemia are excluded. Note: PML/RAR alfa negative APL patients are excluded because those are impossible for evaluating MRD. 3) Age: 15 to 70. 4) Performance status(ECOG):0,1,2,3 5) Adequate organ functions are needed. T-Bil below 2.0 mg/dl Creatinine below 2.0 mg/dl PaO2 over 60mmHg or SpO2 over 93% Severe abnormality of ECG or dysfunction by measurement of cardiac echography(EF beyond 50%) 6) Written Informed consent should be necessary.
Key exclusion criteria	Exclusion criteria are as follows, 1) Patients with uncontrolled infection including active tuberculosis. 2) Patients with severe complications: malignant hypertension, congestive heart failure, acute myocardial infarction occurred within 3 months, liver cirrhosis, poorly controlled diabetes mellitus, pulmonary fibrosis, interstitial pneumonitis, etc) 3) HIV or HBs or HCV are positive. 4) Patients with other malignancy that are untreated or uncontrollable. 5) During or possibility of pregnancy, and lactation for infants. 6) Patients with severe mental disorders. 7) Patients with past history of renal insufficiency. 8) Any conditions that may be inappropriate for registration judged by doctors concerning for patients.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Katsuji Shinagawa
Organization	Okayama University Hospital
Division name	Division of Hematology and Oncology
Zip code
Address	700-8558 Shikata-cho, Okayama city, Okayama, Japan
TEL	086-235-7227
Email

Public contact
Name of contact person	1st name Middle name Last name Katsuji Shinagawa
Organization	Okayama University Hospital
Division name	Division of Hematology and Oncology
Zip code
Address	700-8558 Shikata-cho, Okayama city, Okayama, Japan
TEL	086-235-7227
Homepage URL	http://web.kanazawa-u.ac.jp/sohtake/jalsg/
Email	jalsgsc@hama-med.ac.jp

Sponsor
Institute	Japan Adult Leukemia Study Group (JALSG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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IRB Contact (For public release)
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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	2005 Year 09 Month 13 Day

Related information
URL releasing protocol	http://web.kanazawa-u.ac.jp/sohtake/jalsg/
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
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Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status
Date of protocol fixation	2004 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date	2004 Year 05 Month 01 Day
Last follow-up date	2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
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Other
Other related information

Management information
Registered date	2005 Year 09 Month 10 Day
Last modified on	2005 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000225

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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