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Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia

ConditionLeukemia, Lymphoid
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Consolidation #4(without daunorubicin)

    Drug

    1. Induction chemotherapy(5wks) : Prednisolone, Dexamethasone, Vincristine, Daunorubicin, L-asparaginase, Cytarabine, intrathecal cytarabine, intrathecal methotrexate 2. Low Risk Cosolidation 1 chemotherapy(3wks) : Cytarabine, Etoposide, Cyclophosphamide, intrathecal methotrexate 3. Low Risk Cosolidation 2 chemotherapy(3wks) : Methotrexate, 6-mercaptopurine, intrathecal methotrexate 4. Low Risk Cosolidation 3 chemotherapy(3wks) : Cytarabine, L-asparaginase, intrathecal methotrexate 5. Low Risk Cosolidation 3 chemotherapy(8wks) : Dexamethasone, Vincristine, Daunorubicin, Cytarabine, Cyclophosphamide, 6-mercaptopurine, intrathecal methotrexate 6. Maintenance chemotherapy(about 2yrs) : Vincristine, Dexamethasone, 6-mercaptopurine, intrathecal methotrexate

  • Consolidation #4(with daunorubicin)

    Drug

    1. Induction chemotherapy(5wks) : Prednisolone, Dexamethasone, Vincristine, Daunorubicin, L-asparaginase, Cytarabine, intrathecal cytarabine, intrathecal methotrexate 2. High Risk Cosolidation 1 chemotherapy(3wks) : Cytarabine, Etoposide, Cyclophosphamide, Daunorubicin intrathecal methotrexate 3. High Risk Cosolidation 2 chemotherapy(3wks) : Methotrexate, 6-mercaptopurine, intrathecal methotrexate 4. High Risk Cosolidation 3 chemotherapy(3wks) : Cytarabine, L-asparaginase, intrathecal methotrexate 5. High Risk Cosolidation 3 chemotherapy(8wks) : Dexamethasone, Vincristine, Daunorubicin, Cytarabine, Cyclophosphamide, 6-mercaptopurine, intrathecal methotrexate 6. Maintenance chemotherapy(about 2yrs) : Vincristine, Dexamethasone, 6-mercaptopurine, intrathecal methotrexate

  • Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin)

    Drug

    1. Induction chemotherapy(5wks) : Prednisolone, Dexamethasone, Vincristine, Daunorubicin, L-asparaginase, Cytarabine, intrathecal cytarabine, intrathecal methotrexate 2. High Risk Cosolidation 1 chemotherapy(3wks) : Cytarabine, Etoposide, Cyclophosphamide, Daunorubicin intrathecal methotrexate 3. High Risk Cosolidation 2 chemotherapy(3wks) : Methotrexate, 6-mercaptopurine, intrathecal methotrexate 4. High Risk Cosolidation 3 chemotherapy(3wks) : Cytarabine, L-asparaginase, intrathecal methotrexate 5. High Risk Cosolidation 3 chemotherapy(8wks) : Dexamethasone, Vincristine, Daunorubicin, Cytarabine, Cyclophosphamide, 6-mercaptopurine, intrathecal methotrexate 6. Allogeneic hematopoietic stem cell transplantation

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: Low risk groupExperimental treatment 1 intervention
Group B: Intermediate risk groupExperimental treatment 1 intervention
Group C: High risk groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

3-years Overall survival(OS) rate

The 3-years overall survival rate defined as the percentage of subject in a treatment group who are alive three years after the start of treatm

Time frame
3-years

Secondary outcomes

1

Overall survival (OS)

The overall survival rate defined as the percentage of subject in a treatment group who are alive five years after the start of treatment.

Time frame
Up to 5years
2

Event Free Survial(EFS)

EFS is defined as the period from study enrollment until disease progression, including hematological recurrence of ALL, development of secondary malignancy, or death from any causes, whichever occurs earlier.

Time frame
3-years and 5-years
3

The rate of hematopoietic stem cell transplant patients by risk group

through study completion, an average of 1 year

Time frame
Up to 5years
4

recurred rate

As a the period from enrollment to disease progression/recurrence

Time frame
Up to 5years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yonsei University

Lead sponsor

Source ClinicalTrials.gov
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