Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02339350
Other study ID # KSPHO_HRALL
Secondary ID
Status Recruiting
Phase Phase 2
First received January 12, 2015
Last updated January 15, 2015
Start date January 2015
Est. completion date April 2023

Study information

Verified date January 2015
Source The Korean Society of Pediatric Hematology Oncology
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

Treatment of pediatric acute lymphoblastic leukemia (ALL) has advanced and the overall survival exceeds 80% nowadays. However the overall survival of high risk ALL remains 75-90%, thus recent studies focus on treatment intensification according to the risk group. According to the previous reports, we designed a multicenter prospective trial for pediatric ALL.


Description:

Purpose of the study

1. For slow early responder (SER), to confirm if the augmented interim maintenance using intravenous high dose methotrexate will improve the treatment outcome.

2. For slow early responder (SER), to confirm if removal of prophylactic radiotherapy will relieve long term complications.

3. To predict the treatment response and prognosis high risk pediatric ALL by monitoring of minimal residual disease (MRD).

Inclusion criteria

1. Diagnosis

1. Newly diagnosed B-precursor ALL meeting criteria 1.2

2. Newly diagnosed B-precursor ALL who was previously treated with steroid.

3. Newly diagnosed T cell ALL, excluding early T-cell precursor (ETP) leukemia

1.2 Initial WBC count

1. from 1 years old to 9 years old : WBC ≥ 50,000/μL

2. from 10 years old to 21 years old : Any WBC

3. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date April 2023
Est. primary completion date April 2023
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 21 Years
Eligibility Inclusion Criteria:

1. Diagnosis

1. Newly diagnosed B-precursor ALL meeting criteria 1.2

2. Newly diagnosed B-precursor ALL who was previously treated with steroid.

3. Newly diagnosed T cell ALL, excluding early T-cell precursor (ETP) leukemia

1.2 Initial WBC count

1. from 1 years old to 9 years old : WBC = 50,000/µL

2. from 10 years old to 21 years old : Any WBC

3. from 1 years old to 21 years old : Any WBC with Testicular leukemia or CNS leukemia (CNS3)

Exclusion Criteria:

1. Philadelphia chromosome (+) or bcr/abl rearrangement (+)

2. Chromosome <45 by cytogenetics

3. Induction failure (Day 28 M3 marrow (>25% blasts))

4. t(4:11) (as identified by cytogenetics, FISH or molecular studies)

5. Early T-cell precursor leukemia

6. Down syndrome ALL

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
Intrathecal triple chemotherapy
Intrathecal triple chemotherapy for SEG group instead of radiotherapy

Locations

Country Name City State
Korea, Republic of Seoul National University, College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
The Korean Society of Pediatric Hematology Oncology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary event-free survival of SER group 5 years from diagnosis No
Secondary Number of adverse events 5 years from diagnosis Yes
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Recruiting NCT05772000 - Clinical Significance of Occult Central Nervous System Localization
Recruiting NCT05618041 - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies N/A
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Active, not recruiting NCT03114865 - A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance Phase 1/Phase 2
Not yet recruiting NCT06308588 - Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Phase 2
Recruiting NCT05579132 - A Phase Ib/II Study of CN201 in Precursor B-cell Acute Lymphoblastic Leukemia Phase 1/Phase 2
Recruiting NCT04904588 - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide Phase 2
Terminated NCT02231853 - Phase I/II Trial of Early Infusion of Rapidly-generated Multivirus Specific T Cells (MVST) to Prevent Post Transplant Viral Infections Phase 1
Recruiting NCT04969601 - Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings Phase 1/Phase 2
Recruiting NCT06195891 - Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome Phase 1
Withdrawn NCT02815059 - Study of Pts With Philadelphia Chromosome-Pos ALL With Comb of Ibrutinib, Dasatinib, and Prednisone Phase 1
Completed NCT00390793 - Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia. Phase 2
Recruiting NCT05866887 - Insomnia Prevention in Children With Acute Lymphoblastic Leukemia N/A
Completed NCT00026780 - Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
Completed NCT04666025 - SARS-CoV-2 Donor-Recipient Immunity Transfer
Not yet recruiting NCT06350994 - Early Assessment of Cardiac Function After Treatment With CAR-T Cells
Withdrawn NCT04282174 - CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies Phase 2
Not yet recruiting NCT04488237 - Vitamin D and Methotrexate Adverse Effects
Completed NCT02544438 - Study Evaluating the Safety and Efficacy of Astarabine in Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Phase 1/Phase 2