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Recruitment status
Unique ID issued by UMIN C000000154
Receipt No. R000000225
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
Date of disclosure of the study information 2005/09/13
Last modified on 2005/09/13

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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

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
Adverse events
Outcome measures
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
Date analysis concluded

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
Registered date File name

Research case data
Registered date File name


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