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Treatment protocol for acute promyelocytic leukemia -FBMTG-APL2009-

Treatment protocol for acute promyelocytic leukemia -FBMTG-APL2009- - FBMTG-APL2009

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001742
Enrollment
50
Registered
2009-03-01
Start date
2009-03-01
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

Interventions

APL patients who present white blood cell count &gt
3,000 on admission, will receive high-dose of cytarabine plus intrathecal injection in addition to conventional chemotherapy plus ATRA therapy at the consolidation chemotherapy. APL patients who prese
3,000 on admission, will receive conventional chemotherapy combined with ATRA therapy.

Sponsors

Fukuoka Blood & Marrow Transplant Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Acute promyelocytic leukemia by WHO classification 2. The first time treatment example which does not catch chemotherapy or the radiotherapy 3. The case that is equal to or less than 65 years old more than age 15 years old 4. Performance status 0-2 5. A case without the dangerously ill internal organs disorder; T.Bil equal to or less than 2.0mg/dL, Cr equal to or less than 2.0mg/dL 6. The case that an agreement by the document is provided from a patient on explanation because of final examination contents

Exclusion criteria

Exclusion criteria: 1. The case having double cancers 2. The case with an infectious disease having difficulty with control 3. The case with a severe mental disorder 4. The pregnancy or breast-feeding woman 5. The case that the medical attendant judged to be inappropriate

Design outcomes

Primary

MeasureTime frame
3 years disease-free survival

Secondary

MeasureTime frame
5 years disease free survival, CR rate, treatment-related toxicities

Countries

Japan

Contacts

Public ContactToshihiro Miyamoto

Kyushu University Hospital Hematology/ Oncology

toshmiya@intmed1.med.kyushu-u.ac.jp092-642-5230

Outcome results

None listed

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