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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
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 |
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 |
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Condition | ||
Condition | acute promyelocytic leukemia | |
Classification by specialty |
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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 |
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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 | |
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Eligibility | ||||
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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 |
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Name of lead principal investigator |
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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 | ||||||
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Name of contact person |
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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 | |
Institute | Japan Adult Leukemia Study Group (JALSG) |
Institute | |
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Funding Source | |
Organization | Ministry of Health, Labour and Welfare |
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Nationality of Funding Organization | Japan |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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Study ID_2 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | http://web.kanazawa-u.ac.jp/sohtake/jalsg/ |
Publication of results | Unpublished |
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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 | |
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