Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia

Launched by HO JOON IM · Apr 12, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how effective different treatments are for children with relapsed acute lymphoblastic leukemia (ALL), a type of blood cancer. The study involves children aged 1 to 21 who have experienced a relapse of their leukemia, meaning their cancer has returned after treatment. Participants will be grouped based on their risk level—low, high, or highest risk—according to factors such as how long it's been since their last treatment and their response to it. Depending on their group, they may receive a chemotherapy drug called Idarubicin during the reinduction stage, and those in the high-risk group may also get another medication called blinatumomab before a stem cell transplant.

To be eligible for this trial, children must have a confirmed diagnosis of ALL and have not previously undergone certain treatments, like stem cell transplants. They should also have good kidney, liver, and heart function. If your child is selected to participate, they can expect to receive specialized treatments tailored to their needs, and they will be closely monitored throughout the study. It's important for families to know that this trial is actively recruiting participants and aims to improve future treatments for relapsed leukemia in children.

Gender

ALL

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
• • 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