Treatment of Newly Diagnosed High Risk Acute Lymphoblastic Leukemia in Children
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|ClinicalTrials.gov Identifier: NCT02339350|
Recruitment Status : Recruiting
First Posted : January 15, 2015
Last Update Posted : January 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia Child||Drug: high dose methotrexate Drug: Intrathecal triple chemotherapy||Phase 2|
Purpose of the study
- For slow early responder (SER), to confirm if the augmented interim maintenance using intravenous high dose methotrexate will improve the treatment outcome.
- For slow early responder (SER), to confirm if removal of prophylactic radiotherapy will relieve long term complications.
- To predict the treatment response and prognosis high risk pediatric ALL by monitoring of minimal residual disease (MRD).
- Newly diagnosed B-precursor ALL meeting criteria 1.2
- Newly diagnosed B-precursor ALL who was previously treated with steroid.
- Newly diagnosed T cell ALL, excluding early T-cell precursor (ETP) leukemia
1.2 Initial WBC count
- from 1 years old to 9 years old : WBC ≥ 50,000/μL
- from 10 years old to 21 years old : Any WBC
- from 1 years old to 21 years old : Any WBC with Testicular leukemia or CNS leukemia (CNS3)
Exclusion criteria (who are classified as very high risk group) 2.1 Philadelphia chromosome (+) or bcr/abl rearrangement (+) 2.2 Chromosome <45 by cytogenetics 2.3 Induction failure (Day 28 M3 marrow (>25% blasts)) 2.4 t(4:11) (as identified by cytogenetics, FISH or molecular studies) 2.5 Early T-cell precursor leukemia 2.6 Down syndrome ALL
Methods We will classify the patients to rapid early responder (RER) and slow early responder (SER), according to the treatment response after induction remission and risk factors at diagnosis. SER includes M2 (5-25% or leukemic cells at bone marrow exam) or M3 (25% or more of leukemic cells at bone marrow exam) response at the 14th day of the start of induction remission. If a patient showed total WBC count ≥ 100,000/μL, had testis or CNS (CNS 3) involvement at diagnosis and was diagnosed as T-ALL, the patients will also be included into the SER group.
Rapid early responders will undergo interim maintenance two times and reinduction for one time. Slow early responders will undergo two times of interim maintenance treatment with high dose intravenous methotrexate. For SER, adriamycin was previously administered only when absolute neutrophil count and platelet was normal, but it will be administered without restriction in this study. Both groups (RER and SER) will undergo maintenance chemotherapy thereafter, with the treatment duration of 3 years from the 1st interim maintenance for boys and 2 years for girls.
For SER group, prophylactic radiotherapy will not be done and it will be replaced by high dose intravenous methotrexate and intensification of intrathecal chemotherapy by replacing the intrathecal methotrexate to intrathecal cytarabine, methotrexate and hydrocortisone.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Newly Diagnosed High Risk Acute Lymphoblastic Leukemia in Children|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2023|
No Intervention: Rapid early responder group
Experimental: Slow early responder group
Includes : SER, Testis(+), CNS 3, T-cell (non ETP), Initial PB WBC ≥ 100,000/μL
1. SER Consolidation
Drug: high dose methotrexate
HD-MTX IV 5,000 mg/m2 I.V. over 4hr on day 0, 14, 28, 42 of SER interim maintenance schedule
Drug: Intrathecal triple chemotherapy
Intrathecal triple chemotherapy for SEG group instead of radiotherapy
- event-free survival of SER group [ Time Frame: 5 years from diagnosis ]
- Number of adverse events [ Time Frame: 5 years from diagnosis ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02339350
|Korea, Republic of|
|Seoul National University, College of Medicine||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Hee Young Shin, MD, PhD 82-2-2072-2917 firstname.lastname@example.org|