Infants with newly diagnosed acute lymphoblastic leukemia (ALL) less than 1 year of age at the time of diagnosis without prior history of treatment
Conditions
Interventions
Combination chemotherapy. Allogeneic hematopoietic stem cell transplantation for High Risk patients.
Sponsors
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients should meet all the criteria listed below: 1. Patients must be newly diagnosed with acute lymphoblastic leukemia (ALL), acute mixed lineage leukemia (AMLL), acute undifferentiated leukemia (AUL), acute bilineal leukemia, provided the morphology and immunophenotype are predominately lymphoid and non T-lineage. Patients with Mature B-cell ALL, T-ALL, the presence of t(9;22)(q34;q11), t(8;14)(q24;q32), t(2;8)(p13;q24), and t(8;22)(q24;q11), Down syndrome, AMLL with T-ALL criteria, or acute myeloid leukemia (AML) are NOT eligible. 2. Patients must be less than 1 year old at the time of diagnosis. 3. All patients and/or their parents or legal guardians must sign a written informed consent.
Exclusion criteria
Exclusion criteria: Patients should be excluded if either of the below criteria is met: 1. Neonates younger than 30 days AND less than 36 weeks gestational age at the time of diagnosis. 2. Patients whose performance status (PS) score is 4. 3. Patients with organ dysfunction that is inappropriate for the protocol therapy: 3-1. uncontrollable heart failure 3-2. uncontrollable renal failure 3-3. respiratory disease requiring mechanichal ventilation 3-4. severe CNS hemorrhage 4. Patients with uncontrollable infection. 5. Patients with congenital disease or complications that is inappropriate for the protocol therapy. 6. Patients with other malignant disease. 7. Patients with prior history of chemotherapy, radiation therapy, using systemic steroids within 1 week. 8. Patients without signed informed consent legal guardians. 9. Patients whose local physician decided not eligible for the study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year event-free survival (EFS) of infants with MLL-R ALL | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete remission (CR) rate, and bone marrow response after the 1st induciton course. 2. 1-, 3-, and 5-year EFS and overall survival (OS) 3. Feasibility of the protocol therapy for IR/HR patients, and rate of HSCT recieved for HR patients 4. To evaluate relations between Busulphan pharamacokinetics and transplant-related toxicities. 5. To evaluate toxicities with CTCAE ver.3.0 6. Three- or 5-year EFS and OS for all registered patients. *Prognostic factors including MLL status, risk groups, predonisolone response, minimal residual disease (MRD), CR rate, age, WBC, translocation partners in MLL-R group, immunophenotype will be evaluated | — |
Countries
Japan
Contacts
Public ContactDaisuke Tomizawa
National Center for Child Health and Development Division of Leukemia and Lymphoma, Children's Cancer Center
Outcome results
None listed