Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia (ReCALL)
Acute Lymphoid Leukemia
About this trial
This is an interventional health services research trial for Acute Lymphoid Leukemia focused on measuring combination chemotherapy
Eligibility Criteria
Inclusion Criteria: Patients >= 1 year and < 22 years of age at the time of relapse will be eligible Participants must have a histologic diagnosis of acute lymphoblastic leukemia: B-ALL: Precursor B-cell acute lymphoblastic leukemia T-ALL: Precursor T-cell acute lymphoblastic leukemia 1st recurred acute lymphoblastic leukemia patients, recurred parts including marrow. Enrolling patients with combined extra medullary relapse including bone marrow is acceptable. (No limits for extra medullary site) Additionally, subjects whose blast cells in bone marrow are less than 5% (ALL whether type M2 or M3 must be definite) Patients who have never received allogeneic stem cell transplant Patients who have never received blinatumomab before Patients who relapsed within a month after completing 4 therapies Adequate Renal Function -A serum creatinine based on age/gender as follows: 1 to < 2 years - Male (0.6) Female (0.6) 2 to < 6 years - Male (0.8) Female (0.8) 6 to < 10 years - Male (1) Female (1) 10 to < 13 years - Male (1.2) Female (1.2) 13 to < 16 years - Male (1.5) Female (1.4) ≥ 16 years - Male (1.7) Female (1.4) Adequate Liver Function defined as a direct bilirubin <3.0 mg/dL Adequate Cardiac Function defined as: Shortening fraction of ≥ 27% by echocardiogram, or Ejection fraction of ≥ 50% by echocardiogram Lansky (age < 16 years) or Karnofsky (age ≥ 16 years) performance status ≥ 60% at screening Patients with a life expectancy of 1 or more year Patients who are expected to comply with all required study procedures and follow the study protocol in the opinion of the investigator Signed written informed consent and assent forms must be obtained prior to any study procedures Exclusion Criteria: Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia Patients with Philadelphia chromosome positive (Ph+) ALL Patients with CD19-negative recurrent progenitor B-cell acute lymphoblastic leukemia (non-expression of CD19 in peripheral blood or bone marrow by flow cytometry) are not eligible for administration of Blinatumomab Patients with mixed phenotype leukemia Patients with genetic syndrome: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome bone marrow failure syndrome Patients with HIV Female patients who are not proved as infertile or pregnant (Evidence of infertility: History taking of possibilities of pregnancy or urine human chorionic gonadotrophin test negative, amenorrhea more than a year, Natural or artificial (Ex.hormone therapy) menopause status more than a year, surgical sterilization(Ex.Hysterectomy or ovariotomy etc) Currently receiving treatment in another investigational drug study or clinical trial Evidence of unstable conditions that would pose a risk to subject safety or interfere with the patients' compliance Patients with clinically relevant central nervous system (CNS) pathology or active CNS involvement including: unstable epilepsy, uncontrolled seizure, paralysis, aphasia, history of severe brain injury, cerebellar disease, organic brain syndrome, psychosis, coordination/movement disorder Known hypersensitivity to drugs or components to be administered: Idarubicin, Etoposide, Ifosfamide, Cytarabine, Vincristine, Mercaptopurine, Blinatumomab
Sites / Locations
- Severance Hospital
- Samsung Medical Center
- The Catholic University of Korea Seoul St.Mary's Hospital
- Seoul National University Hospital
- Asan Medical Center
Arms of the Study
Arm 1
Experimental
Single group study
Apply Blinatumomab Cycle 1,2, S cycle 1, 2 (High Risk Group)- 4 weeks to patients before transplantation