UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000154 |
|---|---|
| Receipt number | 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 19:33:47 |
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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
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/
jalsgsc@hama-med.ac.jp
Sponsor or person
Institute
Japan Adult Leukemia Study Group (JALSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000225
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