Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children with Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL)

PHASE3RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

February 6, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2029

Conditions
T-cell Lymphoblastic Lymphoma
Interventions
DRUG

Prednisone,Vincristine, Pegylated-asparaginase, Bortezomib,Cytarabine, Cyclophosphamide, Daunorubicin, 6-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

Prednisone,Vincristine, Pegylated-asparaginase, Bortezomib,Cytarabine, Cyclophosphamide, Daunorubicin, 6-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

Prednisone,Vincristine, Pegylated-asparaginase, Bortezomib,Cytarabine, Cyclophosphamide, Daunorubicin, 6-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.

Trial Locations (2)

200127

RECRUITING

Shanghai Children's Medical Center, Shanghai

Unknown

NOT_YET_RECRUITING

West China Second University Hospital, Chengdu

All Listed Sponsors
collaborator

Shanghai Children's Medical Center

OTHER

collaborator

Beijing Children's Hospital

OTHER

collaborator

Children's Hospital of Scow University

UNKNOWN

collaborator

West China Second University Hospital

OTHER

collaborator

Nanjing Children's Hospital

OTHER

collaborator

Qilu Hospital of Shandong University

OTHER

collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

collaborator

Tongji Hospital

OTHER

collaborator

Xiangya Hospital of Central South University

OTHER

collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

collaborator

Cancer hospital of Shandong Province

UNKNOWN

collaborator

Shenzhen Children's Hospital

OTHER_GOV

collaborator

Wuhan Children's Hospital

OTHER

collaborator

Zhejiang University School of Medicine Children's Hospital

UNKNOWN

collaborator

Shanghai Children's Hospital

OTHER

collaborator

Ruijin Hospital

OTHER

collaborator

Second Affiliated Hospital of Anhui Medical University

UNKNOWN

collaborator

Children's Hospital of Hebei Province

OTHER

collaborator

Cancer Hospital of Henan Province

UNKNOWN

collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

collaborator

Qilu Children's Hospital

UNKNOWN

lead

Children's Cancer Group, China

NETWORK