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Tests treatment safety and results for Acute Lymphoid Leukemia
Official title Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT05827549
What this study is testing
What is Reinduction(4weeks)?
Reinduction(4weeks) is an investigational medicine, being studied as a potential treatment for acute lymphoid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is open-label, multi-center, prospective study, which targets childhood patients with relapsed acute lymphostatic leukemia including bone marrow recurrence. Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for relapsed acute lymphoblastic leukemia in children and adolescents.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 22
You may be able to join if
- Patients \ 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...
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- Patients \ 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)...
- 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 -...
- 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
- 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...
- 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...
- Known hypersensitivity to drugs or components to be administered: Idarubicin, Etoposide, Ifosfamide, Cytarabine, Vincristine, Mercaptopurine, Blinatumomab
The study team makes the final eligibility decision.
Where it's taking place
- Hwasun, South Korea
- Seoul, South Korea
- Yangsan, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 22 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hwasun, South Korea; Seoul, South Korea; Yangsan, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.