Children with first relapsed infant MLL gene rearrangement positive acute lymphoblastic leukemia
Conditions
Interventions
Either DL1 or DL0 would be given as a trial therapy. DL1: AZA 2.5mg/kg/dose, 30min DIV, 7 days DL0: AZA 2mg/kg/dose, 30min DIV, 7 days Following 7-day of AZA, one course of chemotherapy selected
Sponsors
National Center for Child Health and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients should meet all the criteria listed below: (1) Patients must be diagnosed as B-cell precursor acute lymphoblastic leukemia (ALL) with MLL gene rearrangement confirmed by FISH. (2) Patients must be a first relapsed case. (3) Patients must be less than 1 year old at the time of initial ALL diagnosis. (4) Patients must be in complete remission following one course of standard induction chemotherapy for relapsed ALL. (5) All patients' parents or legal guardians must sign a written informed consent. (6) Patients must have performance score (PS) of 0 to 3. (7) Patients' peripheral blood cell counts must meet the following criteria; 1. ANC 500/mcL or higher, after 48 hours or longer cessation of G-CSF. 2. Platelet count 50,000/mcL or higher, without platelet transfusion within 3 days. (8) Patients must have sufficient organ function (liver, kidney, heart, lung) at the trial entry; 1. SpO2 96% or higher in room air, no abnormal findings in chest X-ray. 2. No abnormal ECG and UCG findings which require interventions. 3. AST and ALT value within 5 times of normal upper limit. 4. Serum bilirubin value within 2 times of normal upper limit. 5. Creatinine value within 2 times of normal upper limit.
Exclusion criteria
Exclusion criteria: Patients should be excluded if either of the below criteria is met: (1) Patients with uncontrollable infections. (2) Patients with congenital heart disease which require any interventions. (3) Patients with somatic chromosomal abnormalities. (4) Patients with active hemorrhage at study entry. (5) Patients with CNS symptoms at study entry. (6) Patients with other malignant diseases. (7) Patients with isolated extramedullary relapse. (8) Patients with CNS relapse. (9) Patients not eligible for the study entry decided by the primary/co-investigators of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence rate of dose limiting toxicity (DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete remission (CR) rate at the end of the test drug (AZA) administration. 2. CR rate at the end of the trial. | — |
Countries
Japan
Contacts
Public ContactDaisuke Tomizawa
National Center for Child Health and Development Children's Cancer Center
Outcome results
None listed