CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 150 target
Drug / intervention
Prednisone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine +6 moredrug
Likely dose
Prednisone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine 60 mg/m2from record
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Search/NCT02845882
NCT02845882Phase 3ActiveUpdate OverdueUpdated 3mo ago · Completion was 30mo ago
Enrollment Stalled
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Modified BFM (Berlin-Frankfurt-Munster)Backbone Therapy for Chinese Children or Adolescents With Newly Diagnosed Lymphoblastic Lymphoma

Children's Cancer Group, China·interventional·Posted Jul 27, 2016·Updated Mar 18, 2026

In Brief

A Phase 3 clinical trial evaluating Prednisone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, 6-mercaptopurine,Methotrexate, and 5 other interventions for Lymphoblastic Lymphoma. Active but no longer recruiting, targeting 150 participants across 2 sites.

Signals

Enrollment appears stalled

Detailed Summary

The outcomes of children with lymphoblastic lymphoma (LBL) in China in the investigators' previous study were not unexpected. In this study, through further modification treatment protocols and strengthen domestic multicenter collaboration, the investigators try to improve survival for children with LBL when compared to the previous study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoblastic Lymphoma
CountriesChina
CollaboratorsShanghai Children's Medical Center, Tongji Hospital, West China Second University Hospital, Qilu Hospital of Shandong University, Tianjin Medical University Cancer Institute and Hospital, Children's Hospital of Soochow University, Nanjing Children's Hospital, Xiangya Hospital of Central South University

Timeline

Phase 3Active
20162017201820192020202120222023202420252026202720282029203020312032
First PostedJul 27, 2016
Enrollment StartJan 1, 2016
Primary CompletionDec 31, 2023
Study CompletionDec 1, 2031
TodayJul 1, 2026
Enrollment to primary: 8 yearsPosted 9.9 years ago

Interventions

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

Prednisone 60 mg/m2 per day,d1-28, then taper over 9 days; Vincristine 1.5 mg/m2 per day (max 2 mg),d1,8, 15, 22; Daunorubicin 30 mg/m2 per dose,d5,12,19; Pegylated-asparaginase 2000 IU/m2 per dose,d16,36,57; Cyclophosphamide 1000 mg/m2 per dose, d36, 57; Cytarabine 75 mg/m2 /d, d36-42,d 57-63; 6-Mercaptopurine 60 mg/m2 per day, d36-42, 57-63; Triple it, d8,29,36,57 1,8, 15, 22

6-mercaptopurine,Methotrexatedrug

6-Mercaptopurine 25 mg/m2 per day, d1-56; Methotrexate 5g/m2 per dose, d1, 15, 29, 43; Triple it, d1, 15, 29, 43;

Dexamethasone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Doxorubicin, 6-mercaptopurinedrug

Dexamethasone 10 mg/m2 per day, d1-7, d15-21; Vincristine 1.5 mg/m2 per day (max 2 mg), d1, 8, 15; Doxorubicin 30 mg/m2 per dose, d1, 8, 15; Pegylated-asparaginase 2,000 IU/m2 per dose, d3, 24; Cyclophosphamide 1000 mg/m2 per dose, d29; Cytarabine 75 mg/m2 /d, d29-35; 6-Mercaptopurine 60 mg/m2 per day, d29-35; Triple it, d1, 29;

Dexamethasone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Methotrexatedrug

Dexamethasone 20mg/m2/day, d1-5; Vincristine 1.5 mg/m2 per day (max 2 mg), d1, 6; Methotrexate 5000mg/m2, d1; Cyclophosphamide 200mg/m2/dose, q12h×5, d2-4; Cytarabine 2000mg/m2/dose, ，q12h×2, d5; Pegylated-asparaginase 2,000 IU/m2 per dose, d6; Triple it, d1;

Dexamethasone, Vindesine, Methotrexate, Ifosfamide, Daunorubicin, Pegylated-asparaginasedrug

Dexamethasone 20mg/m2/day, d1-5; Vindesine 3mg/m2（MAX 5mg）, d1, 6; Methotrexate 5000mg/m2, d1; Ifosfamide 800mg/m2/dose, q12h×5,d2-4; Daunorubicin 25mg/m2/dose, d5; Pegylated-asparaginase 2,000 IU/m2 per dose, d6; Triple it, d1;

Dexamethasone, Cytarabine, Etoposide, Pegylated-asparaginasedrug

Dexamethasone 20mg/m2/day, d1-5; Cytarabine 2000mg/m2/dose，q12h× 4, d1, 2; Etoposide 100mg/m2/dose，q12h×5, d3,4,5; Pegylated-asparaginase 2,000 IU/m2 per dose, d6; Triple it, d5;

Methotrexate, 6-mercaptopurinedrug

6-mercaptopurine 50 mg/m2 per day, Daily; Methotrexate 20 mg/m2 per dose, Once a week; Triple it, Once every 4 weeks for 12 times;