relapsed acute promyelocytic leukemia (APL)
Conditions
Interventions
This protocol is composed of the following four steps of therapy. 1.Induction therapy :Arsenic trioxide regime 2.Consolidation therapy: two couses of ATO regime 3.PBSCH: High dose araC regime 4.A
Sponsors
Japan adult leukemia study group ( JALSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Relapsed APL 2. Age between 18 and 65 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. Abnormal reaction to ATO and AraC 7. Another severe and/or life threatening disease 8. Pregnant and/or lactating woman 9. Relapse after stem cell transplantation 10.Impossible to process this protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Frequency of abnormal reactions 2.Complete remission rate 3.The amount of CD34 positive cell in PBSCH 4.Frequency of PML/RAR positivity 5.Engraftment of autologous stem cell transplantation 6.Overall Survival 7.Risk analysis | — |
Countries
Japan
Contacts
Public ContactNobuhiko EMI
JALSG Office for JALSG APL205R
Outcome results
None listed