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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000157 |
Receipt No. | R000000227 |
Scientific Title | Phase III Randomized Study of Induction Therapy Comparing Daunorubicin With Idarubicin Followed By Consolidation Therapy Comparing High-Dose Cytarabine With Sequential Multiagent Chemotherapy in Patients With Previously Untreated De Novo Acute Myeloid Leukemia (JALSG AML201 Study) |
Date of disclosure of the study information | 2005/09/12 |
Last modified on | 2011/09/09 |
Basic information | ||
Public title | Phase III Randomized Study of Induction Therapy Comparing Daunorubicin With Idarubicin Followed By Consolidation Therapy Comparing High-Dose Cytarabine With Sequential Multiagent Chemotherapy in Patients With Previously Untreated De Novo Acute Myeloid Leukemia (JALSG AML201 Study) | |
Acronym | Randomized Study of Induction and Consolidation Therapy in Patients With Previously Untreated AML (JALSG AML201 Study) | |
Scientific Title | Phase III Randomized Study of Induction Therapy Comparing Daunorubicin With Idarubicin Followed By Consolidation Therapy Comparing High-Dose Cytarabine With Sequential Multiagent Chemotherapy in Patients With Previously Untreated De Novo Acute Myeloid Leukemia (JALSG AML201 Study) | |
Scientific Title:Acronym | Randomized Study of Induction and Consolidation Therapy in Patients With Previously Untreated AML (JALSG AML201 Study) | |
Region |
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Condition | ||
Condition | Acute Myeloid Leukemia | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Compare Daunorubicin With Idarubicin in Induction Therap Compare High-Dose Cytarabine With Sequential Multiagent Chemotherapy in Consolidation Therapy |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Phase III |
Assessment | |
Primary outcomes | Complete remission rate in induction therapy Relapse-free survival |
Key secondary outcomes | Overall survival Toxicity more than grade 2 |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | YES |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 4 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Daunorubicin | |
Interventions/Control_2 | Idarubicin | |
Interventions/Control_3 | High-Dose Cytarabine | |
Interventions/Control_4 | Sequential Multiagent Chemotherapy | |
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. Newly diagnosed AML (except M3) 2. PS 0-3 (ECOG) 3. Adequate hepatic, renal, pulmonary and cardiac function 4. Written informed consent | |||
Key exclusion criteria | 1. Atypical leukemia 2. History of MDS 3. History of cancer chemotherapy 4. Other active neoplasms 5. Recent history of myocardial infarction or renal failure, 6. Severe comorbidity (diabetes mellitus, infection or liver cirrhosis) 7. Psychological disorders 8. Pregnant and/or lactating woman 9. Positive anti-HIV antibody | |||
Target sample size | 850 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kanazawa University, Graduate School of Medical Science | ||||||
Division name | Department of Clinical Laboratory Science | ||||||
Zip code | |||||||
Address | 5-11-80 Kodatsuno, Kanazawa, Ishikawa | ||||||
TEL | 076-265-2602 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | JALSG AML201 Study Office | ||||||
Division name | Kanazawa University, Graduate School of Medical Science, Department of Clinical Laboratory Science | ||||||
Zip code | |||||||
Address | 5-11-80 Kodatsuno, Kanazawa, Ishikawa | ||||||
TEL | 076-265-2602 | ||||||
Homepage URL | http://www.jalsg.jp/ | ||||||
sohtake@med3.m.kanazawa-u.ac.jp |
Sponsor | |
Institute | Japan Adult Leukemia Study Group |
Institute | |
Department |
Funding Source | |
Organization | Ministry of Health, Labor and Welfare |
Organization | |
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Category of Funding Organization | |
Nationality of Funding Organization | Japan |
Other related organizations | |
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Name of secondary funder(s) |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
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 | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | Published in
Blood. 117(8): 2358 - 2365, 2011. Blood. 117(8): 2366 - 2372, 2011. |
Management information | |||||||
Registered date |
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Last modified on |
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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=R000000227 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |