Lymphoblastic Leukemia, Acute
Conditions
Keywords
acute lymphoblastic leukemia, newly diagnosed, BCR-ABL-negative
Brief summary
The purpose of this study is to investigate the efficacy and safety for treating adult ALL patients with the pediatric protocol.
Detailed description
The prognosis for adult acute lymphoblastic leukemia (ALL) remains poor, which contrasts with that for pediatric ALL. It is regarded that the prognostic diversity is attributable to several differences between adults and children with respect to biological characteristics of leukemic cells, tolerance to anticancer drugs, treatment itself, and so on. It has been reported that adolescent ALL patients who were treated according to the pediatric protocol had a significantly better survival than those who were treated according to the adult protocol, indicating that the difference of treatment may be of considerable importance. To test the hypothesis, the Japan Adult Leukemia Study Group (JALSG) has planned a phase 2 study to treat younger ALL patients who are negative for BCR-ABL with the pediatric regimen which was used by the Japan Association of Childhood Leukemia Study. Those who are positive for BCR-ABL can participate in a separate protocol. The regimen is especially characterized by dose-intensified L-asparaginase, high-dose methotrexate, and intensified maintenance therapy.
Interventions
DRUGMethotrexate
DRUGPrednisolone
DRUGDexamethasone
DRUGVincristine
DRUGPirarubicin
DRUGCyclophosphamide
DRUGL-asparaginase
DRUGCytarabine
DRUGHydrocortisone
DRUGMercaptopurine
Sponsors
Japan Adult Leukemia Study Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* Previously untreated BCR-ABL-negative ALL * Age between 15 and 24 years * Performance status between 0 and 3 (ECOG criteria) * Adequate functioning of the liver (serum bilirubin level \< 2.0 mg/dL); kidneys (serum creatinine level \< 2.0 mg/dL); and heart (left ventricular ejection fraction greater than 50% and no severe abnormalities detected on electrocardiograms and echocardiographs). * Written informed consent to participate in the trial
Exclusion criteria
* Uncontrolled active infection * Another severe and/or life-threatening disease * Positive for HIV antibody and/or hepatitis B surface (HBs) antigen tests * Another primary malignancy which is clinically active and/or requires medical interventions * Pregnant and/or lactating women * Past history of renal failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| The rate of complete remission | 3 years |
Countries
Japan
Contacts
Primary ContactFumihiko Hayakawa, MD
Outcome results
None listed