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

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 - Randomized controlled Phase 3 trial of maintenance therapy in patients with adult acute promyelocytic leukemia (JALSG APL204 Study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000154

Enrollment

300

Registered

2005-09-13

Start date

2004-07-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute promyelocytic leukemia

Interventions

All-trans retinoic acid(ATRA) in maintenace therapy. Patients number requires 120. Tamibarotene(Am80) in maintenance therapy. Patients number requires 120

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Primary endpoint is relapse free survival at the time of hematological or molecular relapse in maintenance therapy period.	—

Secondary

Measure	Time frame
Secondary endpoints include complete remission rate, event free survival(EFS), overall survival(OS) and frequency of adverse effects.	—

Countries

Japan

Contacts

Public ContactKatsuji Shinagawa

Okayama University Hospital Division of Hematology and Oncology

jalsgsc@hama-med.ac.jp086-235-7227

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026