Spots Global Cancer Trial Database for Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia
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Trial Identification
Brief Title: Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia
Official Title: Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia
Study ID: NCT05827549
Conditions
Interventions
Study Description
Brief 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.
Detailed Description: 1. Baseline demographics: Sex, Birth date, expire date (last follow-up date for the survivals) 2. Diagnosis of Acute lymphoblastic leukemia and treatment history: Diagnosed date, treatment history (Stem cell transplantation history, Administration of Blinatumomab history, recurrence date to check whether recurred within a month after received 4 therapies of induction) 3. Tests before actual administration: EKG and or Echo, Blood sample: Complete Blood Count/Diff/Platelets, Chemistry, Urinalysis, HIV, human chorionic gonadotrophin \[female\], Minimal Residual Disease\[Next-generation sequencing, after induction / could be done after 1st, 2nd consolidation therapy\] 4. Bone marrow aspiration
Keywords
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Severance Hospital, Seoul, Gangnam-gu, Korea, Republic of
Samsung Medical Center, Seoul, Gangnam-gu, Korea, Republic of
The Catholic University of Korea Seoul St.Mary's Hospital, Seoul, Gangnam-gu, Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, Jeollanam-do, Korea, Republic of
Seoul National University Hospital, Seoul, Jongro-gu, Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Contact Details
Name: Ho Joon Im, Professor
Affiliation: Asan Medical Center
Role: STUDY_CHAIR
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