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

• Status: Not yet recruiting
• Trial end date: 2032-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is open-label, multi-center, prospective study, which targets childhood patients with recurred acute lymphostatic leukemia including recurrence around marrow. This study is designed to administer Idarubicin for Reinduction stage. Patients with recurrence are sorted into groups with their potential risk, and depending on their recurrence point, time, reaction to treatment etc, they are sorted into low-risk group, high-risk group, and highest-risk group.

Patients with high-risk group are going to be given blinatumomab at consolidation stage before hematopoietic stem cell transplantation.

Patients with low-risk group who are not suitable for hematopoietic stem cell transplantation are going to be maintaining maintenance therapy for 2 years for chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ho Joon Im
• Treatments: Blinatumomab

Criteria

Inclusion Criteria:

• Patients who are confirmed as relapse, aged above a year (12 months), below 22

• 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

• Patients who relapsed within a month after completing 4 therapies

• Adequate Renal Function Creatinine clearance or radioisotope Glomerular filtration rate≥ 70 mL/min/1.73 m2, or

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

Exclusion Criteria:

• Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia

• Patients with genetic syndrome: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome bone marrow failure syndrome

• Patients with 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)