Newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL)
Conditions
Interventions
Induction CPM 1.2 g/m2 (*800 mg/m2) day 1 DNR 60 mg/m2 (*30 mg/m2) day 1-3 VCR 1.3 mg/m2 (max 2 mg)day 1,8,15,22 PSL 60 mg/m2 PO on day 1-21 (*7) tapered Imatinib 600 mg/body/day on day 8-42 MTX
Sponsors
Japan Adult Leukemia Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Informed as ALL 2) Performance Status (ECOG):0-3 3) Total bilirubin <2.0 mg/dL 4) Creatinine <2.0 mg/dL 5) ECG showed no arrythmia of more than grade 3 by CTCAE 6) Obtained written informed consent
Exclusion criteria
Exclusion criteria: 1) Infectious disease of Grade 4 2) Positive HIVAb or HBsAg 3) Active cancer other than ALL 4) Female patients who are pregnant or breast-feeding 5) Reject by responsible physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two-year event free survival. Events are defined as any induction failure, relapse or death of any reason. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Complete remission rate 2) Rate of adverse events 3) Five year overall survival 4) Conversion rate of BCR-ABL product, time to MRD negativity, time to reappearance of MRD and the mutation status of the gene. 5) Efficay and toxicity of transplantation | — |
Countries
Japan
Contacts
Public ContactHideki Akiyama
Tokyo Metropolitan Komagome Hospital Hematology Division
Outcome results
None listed