Trial Title:
Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia
NCT ID:
NCT06516679
Condition:
Leukemia, Lymphoid
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Daunorubicin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
- Low risk group : KMT2A wild type & minimal residual disease(MRD) (-) after
consolidation 1
- Intermediate risk group : Intermediate 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
- High risk group : Somatic KMT2A mutation (+) & minimal residual disease (MRD) (+)
after consolidation 1
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Consolidation #4(without daunorubicin)
Description:
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
Arm group label:
Low risk group
Intervention type:
Drug
Intervention name:
Consolidation #4(with daunorubicin)
Description:
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
Arm group label:
Intermediate risk group
Intervention type:
Drug
Intervention name:
Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin)
Description:
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
Arm group label:
High risk group
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.
Detailed description:
Infant leukemia patients are classified into low/intermediate/high risk groups and
hematopoietic stem cell transplantation is performed after chemotherapy or chemotherapy
as shown in the schema below.
- Low risk group : Induction chemotherapy-Low Risk Consolidation chemotherapy 1~4 -
Maintenance chemotherapy
- Intermediate risk group : Induction chemotherapy-High Risk Consolidation
chemotherapy 1~4 - Maintenance chemotherapy
- High risk group : Induction chemotherapy-High Risk Consolidation chemotherapy 1~4 -
hematopoietic stem cell transplantation
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Administered systemic steroid therapy within 4 weeks prior to this study
- Participants in other interventional studies other than this protocol
Gender:
All
Minimum age:
N/A
Maximum age:
2 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Severance Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Contact:
Last name:
seung min Hahn, MD
Phone:
+82-2-2228-2050
Email:
bluenile88@yuhs.ac
Start date:
August 2024
Completion date:
December 31, 2032
Lead sponsor:
Agency:
Yonsei University
Agency class:
Other
Source:
Yonsei University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06516679
