A Phase 3 interventional study of Prednisone,Vincristine, Pegylated-asparaginase, Bortezomib,Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, methotrexate, Dexamethasone, Doxorubicin and Prednisone,Vincristine, Pegylated-asparaginase, Bortezomib,Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, methotrexate, Dexamethasone, Doxorubicin in T-cell Lymphoblastic Lymphoma, sponsored by Children's Cancer Group, China. Recruiting at 2 sites in China. Open to participants aged 12 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Children's Cancer Group, China · Phase 3, Interventional, and Treatment
T-cell lymphoblastic lymphoma (T-LBL) is the second most common subtype of non-Hodgkin lymphoma (NHL) in children and adolescents. With current treatment, event-free survival (EFS) rates vary between 75%\~85%. Two different MTX intensification strategies are used commonly: HD-MTX with leucovorin rescue, and Capizzi-style MTX without leucovorin rescue plus PEG-ASP (C-MTX). Although superior outcome of patients with T-ALL receiving C-MTX compared with HD-MTX on the AALL0434 trial, the 2 approaches had not been compared directly in patients with T-LBL. There remains controversy on PET/CT interpretation in children with NHL. Large prospective studies in pediatric patients with T-LBL regarding PET/CT value for this is scarce. Around 1% pediatric patients with T-LBL will not achieve remission at the end of Induction (induction failure). The optimal treatment for this small subgroup is largely unclear. The BFM HR Blocks usually are applied to these patients even though the efficacy is unknown. Novel targeted therapies are needed for use. Dasatinib is identified as a targeted therapy for T-cell ALL in preclinical drug screening.
2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.
This study's planned enrollment of 200 is above the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Children's Cancer Group, China is the lead sponsor of 11 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Any pediatric patients with newly diagnosed T-LBL Stage II to IV who achieve at least a PR at the end of Induction (EOI). Induction I followed by consolidation, Capizzi escalating methotrexate (interim maintenance) , delayed intensification and maintenance therapy. Triple intrathecal injections.
Drug: Prednisone,Vincristine, Pegylated-asparaginase, Bortezomib,Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, methotrexate, Dexamethasone, Doxorubicin
Any pediatric patients with newly diagnosed T-LBL Stage II to IV who achieve at least a PR at the end of Induction (EOI). Induction I followed by consolidation, high dose methotrexate (interim maintenance) , delayed intensification and maintenance therapy. Triple intrathecal injections.
Drug: Prednisone,Vincristine, Pegylated-asparaginase, Bortezomib,Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, methotrexate, Dexamethasone, Doxorubicin
Any pediatric patients with newly diagnosed T-LBL Stage II to IV who fail to achieve at least a PR at the end of Induction (EOI). Induction I followed by 6 intensive polychemotherapy blocks (HR1'-HR2'-HR3'-HR1'-HR2'-HR3'), deIayed intensification, and maintenance therapy. Triple intrathecal injections.
Drug: Prednisone,Vincristine, Pegylated-asparaginase, Bortezomib,Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, methotrexate, Dexamethasone, Doxorubicin, Vindesine, Etoposide, Ifosfamide
Drug pages: Prednisone · Vincristine · Pegaspargase · Bortezomib · Cytarabine · Cyclophosphamide · Daunorubicin · Mercaptopurine · Methotrexate · Dexamethasone · Doxorubicin
Standard risk Arm A: Induction I followed by Consolidation, extracompartmental Capizzi MTX, delayed intensification and 96 weeks' maintenance therapy. Twenty-one or twenty-six triple intrathecal injections for CNS negative or positive patients, respectively.
Drug pages: Prednisone · Vincristine · Pegaspargase · Bortezomib · Cytarabine · Cyclophosphamide · Daunorubicin · Mercaptopurine · Methotrexate · Dexamethasone · Doxorubicin
Standard risk Arm B: Induction I followed by Consolidation, extracompartmental high dose MTX, delayed intensification and 96 weeks' maintenance therapy. Twenty-one or twenty-six triple intrathecal injections for CNS negative or positive patients, respectively.
Drug pages: Prednisone · Vincristine · Pegaspargase · Bortezomib · Cytarabine · Cyclophosphamide · Daunorubicin · Mercaptopurine · Methotrexate · Dexamethasone · Doxorubicin · Vindesine · Etoposide · Ifosfamide
High Risk T-LBL: Induction I followed by 2 cycles of BFM HR Blocks, delayed intensification and 96 weeks' maintenance therapy. Twenty-four or twenty-eight triple intrathecal injections for CNS negative or positive patients, respectively.
Event free survival for standard risk patients
To determine the EFS in patients with newly diagnosed standard T-LBL, through randomization, the modified COG ABFM regimen with CMTX to the regimen with HD MTX
Time frame: 4 years
Event free survival according to bone marrow MDD
After using the modified COG ABFM regimen, to validate whether bone marrow MDD by Flow at diagnosis is still a prognostic factor for pediatric patients newly diagnosed with T-LBL
Time frame: 4 years
Event free survival for high risk patients
To determine the EFS in patients with induction failure who become complete or partial response after using 3 HR BFM Blocks and continue chemotherapy on 3 HR BFM Blocks followed by delayed intensification and maintenance therapy.
Time frame: 4 years
Started Feb 2023 (actual). Primary completion is estimated for Dec 2026, 46 months after the start.
Of 43 non-industry phase 3 interventional studies under Precursor Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 95 months of starting (the median), counting those still running; a quarter within 65 and three quarters within 109. This study's planned 46 months is below that.
Counting every sponsor, half of 59 studies reached it within 86 months; a quarter within 46 and three quarters within 104.
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Studies of the drugs tested here: Prednisone · Vincristine · Pegaspargase · Bortezomib · Cytarabine · Cyclophosphamide · Daunorubicin · Mercaptopurine · Methotrexate · Dexamethasone · Doxorubicin · Vindesine · Etoposide · Ifosfamide
Precursor Cell Lymphoblastic Leukemia-Lymphoma →
Children's Cancer Group, China