Evaluating treatment effectiveness for relapsed childhood acute lymphoblastic leukemia based on risk groups

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multi-center, prospective study focuses on children with relapsed acute lymphoblastic leukemia (ALL). Patients are categorized into low, high, and highest-risk groups based on their recurrence characteristics and treatment responses. The study involves administering Idarubicin during the reinduction phase, with high-risk patients receiving blinatumomab before hematopoietic stem cell transplantation, while low-risk patients undergo maintenance chemotherapy for two years. Comprehensive assessments, including blood tests and bone marrow aspirations, are conducted to monitor patient health and treatment efficacy.

Why it matters

Who can join: the full rules

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
* Adequate Renal Function

  -A serum creatinine based on age/gender as follows:

  1 to \&lt; 2 years - Male (0.6) Female (0.6) 2 to \&lt; 6 years - Male (0.8) Female (0.8) 6 to \&lt; 10 years - Male (1) Female (1) 10 to \&lt; 13 years - Male (1.2) Female (1.2) 13 to \&lt; 16 years - Male (1.5) Female (1.4)

  ≥ 16 years - Male (1.7) Female (1.4)
* Adequate Liver Function defined as a direct bilirubin \&lt;3.0 mg/dL
* Adequate Cardiac Function defined as: Shortening fraction of ≥ 27% by echocardiogram, or Ejection fraction of ≥ 50% by echocardiogram
* Lansky (age \&lt; 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
* In case of relapsed within 1 month after the end of induction with the same 4-drug therapy used in this study
* Patients with 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
* Patients with known 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\&#39; 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

Where it's running

• Chonnam National University Hwasun Hospital
  Hwasun, South Korea Recruiting
• Seoul National University Hospital
  Seoul, South Korea Recruiting
• Severance Hospital
  Seoul, South Korea Recruiting
• Asan Medical Center
  Seoul, South Korea Recruiting
• Samsung Medical Center
  Seoul, South Korea Recruiting
• Seoul saint Mary's Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Ho Joon Im
• Email: hojim@amc.seoul.kr
• Phone: +82-10-6231-1573

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.