Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia-prospective, Nationwide, Multi-center Study

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

* Clinical and genetic factors consistent with High risk : Induction → Consolidation 1. BM MRD \&lt; 0.01% : IM #1 → DI #1 → IM #2 → Maintenance 2. BM MRD ≥ 0.01% : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance 3. BM MRD ≥ 0.01% after Consolidation <!-- --> 1. T cell ALL : Change to very high risk regimen 2. Pre-B ALL : IM #1 → Intensification 1. BM MRD \&lt; 0.01% after IM #1 : DI #1 → IM #2 → DI #2 → Maintenance 2. BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen * Difference in the number of \&#39;interim maintenance(IM)\&#39; and \&#39;delayed intensification(DI)\&#39; is important for chemotherapies based on MRD.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 19
Healthy Volunteers: f
View:

• Age: 1year\

∙ 19years of age at diagnosis

• Patients who are newly diagnosed Pre-B ALL and meet one of the following criteria

‣ High-risk group according to the National Cancer Institute (NCI)/Rome: Age greater than or equal to 10 years and less than 19 years at diagnosis, or white blood cell count greater than or equal to 50 x 10\^9/L at diagnosis

⁃ If extra-bone marrow lesions are identified at the time of diagnosis, Central nervous system involvement (CNS3) or testicular involvement

⁃ High-risk gene variants:

∙ KMT2A rearrangement intrachromosomal amplification of chromosome 21 (iAMP21)

∙ ● If subjects are under the age of 10 at the time of diagnosis and took steroids for more than 24 hours within two weeks before the diagnosis, the risk group will be determined by the presence of a whole blood test within three days before starting steroids. If a whole blood test is performed within three days before beginning steroids, the risk group will be assessed based on the white blood cell count in the test. If there is no whole blood test before starting steroids, subjects are classified as a high-risk group. If subjects are ten or older at diagnosis, pre-diagnosis steroid treatment will not affect the risk classification.

• Newly diagnosed T cell ALL

Locations
Other Locations
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Korea University Anam Hospital
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Seoul saint Mary's Hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
Pusan National University Yangsan Hospital
RECRUITING
Yangsan
Contact Information
Primary
Jae Wook Lee, Ph.D
dashwood@catholic.ac.kr
82-2-2258-6192
Time Frame
Start Date: 2024-08-10
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 370
Treatments
Experimental: ALL, High risk with DI #2(Doxorubicin)
* Clinical and genetic factors consistent with High risk : Induction → Consolidation~ 1. BM MRD \&lt; 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance~ 2. BM MRD ≥ 0.01% after Induction, \&lt; 0.01% after Consolidation : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance~ 3. BM MRD ≥ 0.01% after Consolidation~ <!-- -->~ 1. T cell ALL : Change to very high risk regimen~ 2. Pre-B ALL : IM #1 → Intensification~ 1. BM MRD \&lt; 0.01% after IM #1 : Continue with \&#39;No. 2\&#39; of High risk regimen starting with DI #1~ 2. BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen~ * T cell ALL patients with M1 BM post-Consolidation will start IM #1. However, the patients will switch to Very high risk regimen at the next chemotherapy cycle once post-Consolidation MRD ≥ 0.01% has been reported.
Sponsors
Collaborators: Seoul National University Hospital, Samsung Medical Center, Asan Medical Center, Pusan National University Yangsan Hospital, Severance Hospital, Korea University Anam Hospital
Leads: Jae Wook Lee

This content was sourced from clinicaltrials.gov