Evaluating treatment effectiveness for relapsed childhood acute lymphoblastic leukemia based on risk groups
Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia
This study is testing different treatment plans for children with relapsed acute lymphoblastic leukemia to see which works best based on their risk level.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 1 Year to 22 Years |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Drugs / interventions | blinatumomab |
| Locations | 7 sites (Hwasun and 6 other locations) |
| Trial ID | NCT05827549 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to 22 years with a histologic diagnosis of relapsed acute lymphoblastic leukemia who have not previously received blinatumomab or allogeneic stem cell transplantation.
Not a fit: Patients with advanced disease requiring immediate intervention or those who have previously received blinatumomab or stem cell transplants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for children with relapsed acute lymphoblastic leukemia by tailoring therapies based on individual risk profiles.
How similar studies have performed: Other studies have shown promising results with similar risk-based treatment approaches in childhood leukemia, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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 * 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 * 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\' 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 this trial is running
Hwasun and 6 other locations
- 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)
- Pusan National University Yangsan Hospital — Yangsan, South Korea (Recruiting)
Study contacts
- Study coordinator: Ho Joon Im
- Email: hojim@amc.seoul.kr
- Phone: +82-10-6231-1573
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.