Multicenter study of a randomized controlled trial with or without maintenance/intensification therapy in patients with previously untreated acute promyelocytic leukemia (JALSG APL97 study)

Multicenter study of a randomized controlled trial with or without maintenance/intensification therapy in patients with previously untreated acute promyelocytic leukemia (JALSG APL97 study) - Randomized trial with or without maintenance/intensification therapy in patients with acute promyelocytic leukemia (JALSG APL97 study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000206

Enrollment

234

Registered

2005-09-14

Start date

1997-05-01

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 (APL)

Interventions

6 courses of maintenance/intencification therapy consisting of enocitabine, daunorubicin, mercaptopurine, mitoxantrone, etoposide, vindesine, and aclarubicin no maintenance/intensification therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Previously untreated APL 2. Age between 15 and 70 years 3. Performance status between 0 and 3 (ECOG criteria) 4. Adequate functioning of the liver (serum bilirubin level 60 mmHg or SpO2 > 93%) and heart (no severe abnormalities detected on electrocardiograms) 5. Written informed consent to participate the trial

Exclusion criteria

Exclusion criteria: 1. Uncontrolled active infection 2. Past history of myocardial infarction or cardiac failure 3. Past history of renal failure 4. Uncontrolled diabetes mellitus 5. Liver cirrhosis 6. Leukemic involvement in the CNS 7. Another severe and/or life threatening disease 8. Pregnant and/or lactating woman 9. Positive for HIV antibody test

Design outcomes

Primary

Measure	Time frame
relapse-free survival at 5 years	—

Secondary

Measure	Time frame
overall survival at 5 years, complete remission rate, event-free survival at 5 years, efficacy of detection of PML-RARalpha	—

Countries

Japan

Contacts

Public ContactNorio Asou

Kumamoto University School of Medicine Department of Hematology

ktcnasou@gpo.kumamoto-u.ac.jp096-373-5156

Outcome results

None listed

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