None listed
Conditions
Interventions
Drug : Apply Blinatumomab Cycle 1, 2, S cycle 1, 2 (High Risk Group) – 4 Weeks to patients before transplantation.
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients >= 1 year and < 22 years of age at the time of relapse will be eligible 2. Diagnosis • 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 • Patients with acute lymphoblastic leukemia who relapsed primarily in a site including the bone marrow. However, patients with combined extra-medullary relapse including the bone marrow can be enrolled (No restrictions on extra-medullary sites) In addition, subjects must have = 5% blast cells in the bone marrow (M2 or M3 ALL must be present.) 3. Patients who have not previously received blinatumomab 4. Adequate Renal Function 4.1 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) 4.2 Adequate Liver Function defined as a direct bilirubin < 3.0 mg/dL 5. Other • 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
Exclusion criteria: • B-cell ALL exclusions; - Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia - Patients with Philadelphia chromosome positive (Ph+) ALL • Patients are not eligible for administration of Blinatumomab : CD19-negative recurrent precursor B-cell acute lymphoblastic leukemia • mixed phenotype leukemia • Patient who was relapsed within 1 month after the end of induction therapy with the same 4-drug regimen to be used in this study. • Patients with genetic syndrome: - Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome bone marrow failure syndrome • 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 • In case of contraindications to the drugs used in this clinical trial • In the presence of electrocardiographic findings suggesting uncontrolled cardiac dysfunction (e.g., unstable ischemia, symptomatic arrhythmia, congestive heart failure) or congenital long QT syndrom • Known HIV infection patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients with relapsed acute lymphoblastic leukemia are being treated after sorted into groups with their potential risk, and disease-free surviavl rate will be checked. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bilnatumomab is used before transplantation to patients with high risk, and disease-free survival rate will be compared with the study before.;Patients with standard risk who are not eligible for allogenic stem cell transplantation are given consolidation and maintainence therapies, and disease-free survival rate will be compared with the study before.;Comparing minimal residual disease negative rate with the study before by adding bilnatumomab to patients in high risk group;children and adolescents who have relapsed acute lymphoblastic leukemia are administered different treatments depending on their assigned groups, and disease-free survival rate will be compared with the study before.;Comparing remission rate and occurrence rate of toxicity during re-intervention therapy after changed schedules of idraubicin;Checking occurenece rate of toxicity related to treatment during consolidation for patients in low-risk group | — |
Countries
Korea, Republic of
Contacts
Public ContactYun Jung Go
The Korean Society of Pediatric Hematology-Oncology
Outcome results
None listed