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Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia: A Multicenter, Prospective Study

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This clinical trial is an open-label, multicenter, prospective phase 2 clinical trial targeting pediatric leukemia patients of infant age. The goal is to improve survival rates by varying the presence or absence of chemotherapy and hematopoietic stem cell transplantation based on genetic characteristics at the time of diagnosis and minimal residual disease (MRD) values measured by various methods after treatment. In addition, by clearly defining the patient group that requires hematopoietic stem cell transplantation, it is expected that the role of hematopoietic stem cell transplantation in infantile leukemia, for which there have been various guidelines for hematopoietic stem cell transplantation, can be confirmed. Additionally, due to the characteristics of infants, this study aim to identify long-term sequelae or prognosis related to treatment by prospectively collecting side effect data related to treatment during and after treatment.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 2
Healthy Volunteers: f
View:

• The age of diagnosis is less than 1 year old

• The disgnosisi of ALL or ALAL(lymphoid predominant)

• Informed consent of the parents(guardians) before participation in this study

Locations
Other Locations
Republic of Korea
Chonnam National University Hwasun Hospital
RECRUITING
Hwasun
Jeju National University Hospital
RECRUITING
Jeju City
Pusan National University Yangsan Hospital
RECRUITING
Pusan
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Cente
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Seoul saint Mary's Hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
Time Frame
Start Date: 2024-12-11
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 40
Treatments
Experimental: Low risk group
KMT2A wild type \& minimal residual disease(MRD) (-) after consolidation 1
Experimental: Intermediate risk group
ntermediate risk (If one of the two cases below applies)~* KMT2A: MLL mutation (+) \& minimal residual disease (MRD) (-) after consolidation 1~ * KMT2A: wild type \& minimal residual disease (MRD) (+) after consolidation 1
Experimental: High risk group
Somatic KMT2A mutation (+) \& minimal residual disease (MRD) (+) after consolidation 1
Related Therapeutic Areas
Sponsors
Leads: Yonsei University

This content was sourced from clinicaltrials.gov

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