Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 2
SponsorYonsei University

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Burkitt leukemia/lymphoma or mature B-cell leukemia

Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or other bone marrow failure syndrome, hematopoietic stem cell transplantation

Relapsed infant leukemia

Participants with contraindication to medication

Trial design

Treatments tested in this trial

  • Consolidation #4(without daunorubicin)
  • Consolidation #4(with daunorubicin)
  • Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin)

Treatment groups

40 Participants
are divided into 3 treatment groups

Sponsors and collaborators