NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000154

Registered date:13/09/2005

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

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedacute promyelocytic leukemia
Date of first enrollment2004/05/01
Target sample size300
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)All-trans retinoic acid(ATRA) in maintenace therapy. Patients number requires 120. Tamibarotene(Am80) in maintenance therapy. Patients number requires 120

Outcome(s)

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

Key inclusion & exclusion criteria

Age minimum15years-old
Age maximum70years-old
GenderMale and Female
Include criteriaEligibility 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.
Exclude criteriaExclusion 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.

Related Information

Contact

public contact
Name Katsuji Shinagawa
Address 700-8558 Shikata-cho, Okayama city, Okayama, Japan Japan
Telephone 086-235-7227
E-mail jalsgsc@hama-med.ac.jp
Affiliation Okayama University Hospital Division of Hematology and Oncology
scientific contact
Name Katsuji Shinagawa
Address 700-8558 Shikata-cho, Okayama city, Okayama, Japan Japan
Telephone 086-235-7227
E-mail
Affiliation Okayama University Hospital Division of Hematology and Oncology