Evaluation of treatment efficacy according to risk group in relapsed childhood acute lymphoblastic leukemia
- Conditions
- Neoplasms
- Registration Number
- KCT0008729
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 90
1. Patients >= 1 year and < 22 years of age at the time of relapse will be eligible
2. 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
3. 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)
4. Patients who have never received allogeneic stem cell transplant
5. Patients who have never received blinatumomab before
6. 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)
7. Adequate Liver Function defined as a direct bilirubin < 3.0 mg/dL
8. Adequate Cardiac Function defined as
Shortening fraction of = 27% by echocardiogram, or
Ejection fraction of = 50% by echocardiogram
9. Lansky (age < 16 years) or Karnofsky (age = 16 years) performance status = 60% at screening
10. Patients with a life expectancy of 1 or more year
11. Patients who are expected to comply with all required study procedures and follow the study protocol in the opinion of the investigator
12. Signed written informed consent and assent forms must be obtained prior to any study procedures
1. Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia
2. Patients with Philadelphia chromosome positive (Ph+) ALL
3. 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
4. In case of relapsed within 1 month after the end of induction with the same 4-drug therapy used in this study
5. Patients with mixed phenotype leukemia
6. Patients with genetic syndrome: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome bone marrow failure syndrome
7. Patients with HIV
8. 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)
9. Currently receiving treatment in another investigational drug study or clinical trial
10. Evidence of unstable conditions that would pose a risk to subject safety or interfere with the patients' compliance
11. 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
12. Known hypersensitivity to drugs or components to be administered: Idarubicin, Etoposide, Ifosfamide, Cytarabine, Vincristine, Mercaptopurine, Blinatumomab
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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