Post remission therapy with arsenic trioxide and gemtuzumab ozogamicin in acute promylocytic leukemia, a phase II study (JALSG APL212 Study)

Post remission therapy with arsenic trioxide and gemtuzumab ozogamicin in acute promylocytic leukemia, a phase II study (JALSG APL212 Study) - Post remission therapy with arsenic trioxide and gemtuzumab ozogamicin in acute promylocytic leukemia (JALSG APL212)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008470

Enrollment

222

Registered

2012-07-19

Start date

2012-07-01

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

Adult acute promylocytic leukemia

Interventions

all-trans retinoic acid idarubicin cytarabine arsenic trioxide daunorubicin gemtuzumab ozogamicin tamibarotene (Am80)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed APL (FAB: M3 or M3v) 2. Performance status (ECOG): 0-2 3. Adequate cardiac, pulmonary, hepatic and renal function 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. History of myelodysplastic syndrome 2. Atypical acute leukemia 3. Uncontrollable infection 4. Severe co-morbidity 5. Positive anti-HIV antibody, HBs antigen or anti-HCV antibody 6. Other active neoplasm 7. Pregnant and/or lactating woman 8. Psychological disorders 9. Patients who have a difficulty to enter the study.

Design outcomes

Primary

Measure	Time frame
3-year event free survival (EFS)	—

Secondary

Measure	Time frame
1. Complete remission rate (CR) 2. 3- and 5-year disease free survival (DFS)of patients in CR 3. 3- and 5-year overall survival (OS) 4. 5-year event free survival (EFS) 5. CR, DFS and OS of each group 6. Adverse events. 7. Analyses of PML-RARA isoform, FLT3/ITD mutation, CD56 expression, additional chromosome abnormality and their effects on prognosis 8. Coagulation and fibrinolysis factors, and their effects on prognosis. 9. Determination of genetic abnormality and polymorphism of by genome and exome analyses for treatment related adverse events including APL differentiation syndrome. 10. Determination of genetic abnormality and polymorphism of by genome and exome analyses for the efficacy of treatment.	—

Measure

Time frame

1. Complete remission rate (CR) 2. 3- and 5-year disease free survival (DFS)of patients in CR 3. 3- and 5-year overall survival (OS) 4. 5-year event free survival (EFS) 5. CR, DFS and OS of each group 6. Adverse events. 7. Analyses of PML-RARA isoform, FLT3/ITD mutation, CD56 expression, additional chromosome abnormality and their effects on prognosis 8. Coagulation and fibrinolysis factors, and their effects on prognosis. 9. Determination of genetic abnormality and polymorphism of by genome and exome analyses for treatment related adverse events including APL differentiation syndrome. 10. Determination of genetic abnormality and polymorphism of by genome and exome analyses for the efficacy of treatment.

—

Countries

Japan

Contacts

Public ContactAkihiro Takeshita

Hamamatsu University School of Medicine Internal Medicine

akihirot@hama-med.ac.jp(+81)-53-433-4993

Outcome results

None listed

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