drugset / Trial / NCT02845882
LBL-2016 for Children or Adolescents in China
Phase 3
Active not recruiting
150 enrolled
Children's Cancer Group, China
Children's Hospital of Soochow University · collabNanjing Children's Hospital · collabQilu Hospital of Shandong University · collabShanghai Children's Medical Center · collabTianjin Medical University Cancer Institute and Hospital · collabTongji Hospital · collabWest China Second University Hospital · collabXiangya Hospital of Central South University · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2016-01
- Primary completion
- 2023-12-31
- Completion
- 2031-12
Publications
- Results Burkhardt B, Reiter A, Landmann E, Lang P, Lassay L, Dickerhoff R, Lakomek M, Henze G, von Stackelberg A. Poor outcome for children and adolescents with progressive disease or relapse of lymphoblastic lymphoma: a report from the berlin-frankfurt-muenster group. J Clin Oncol. 2009 Jul 10;27(20):3363-9. doi: 10.1200/JCO.2008.19.3367. Epub 2009 May 11.
- Results Reiter A, Schrappe M, Ludwig WD, Tiemann M, Parwaresch R, Zimmermann M, Schirg E, Henze G, Schellong G, Gadner H, Riehm H. Intensive ALL-type therapy without local radiotherapy provides a 90% event-free survival for children with T-cell lymphoblastic lymphoma: a BFM group report. Blood. 2000 Jan 15;95(2):416-21.
- Results Moghrabi A, Levy DE, Asselin B, Barr R, Clavell L, Hurwitz C, Samson Y, Schorin M, Dalton VK, Lipshultz SE, Neuberg DS, Gelber RD, Cohen HJ, Sallan SE, Silverman LB. Results of the Dana-Farber Cancer Institute ALL Consortium Protocol 95-01 for children with acute lymphoblastic leukemia. Blood. 2007 Feb 1;109(3):896-904. doi: 10.1182/blood-2006-06-027714. Epub 2006 Sep 26.
- Results Stary J, Zimmermann M, Campbell M, Castillo L, Dibar E, Donska S, Gonzalez A, Izraeli S, Janic D, Jazbec J, Konja J, Kaiserova E, Kowalczyk J, Kovacs G, Li CK, Magyarosy E, Popa A, Stark B, Jabali Y, Trka J, Hrusak O, Riehm H, Masera G, Schrappe M. Intensive chemotherapy for childhood acute lymphoblastic leukemia: results of the randomized intercontinental trial ALL IC-BFM 2002. J Clin Oncol. 2014 Jan 20;32(3):174-84. doi: 10.1200/JCO.2013.48.6522. Epub 2013 Dec 16.
- Results Lymphoma Study Group, Subspecialty Group of Hematology, the Society of Pediatrics, Chinese Medical Association; Lymphoma Study Group Committee of Pediatrics Chinese Anti-Cancer Association. [A collaborative study of children with lymphoblastic non-Hodgkin's lymphoma in China]. Zhonghua Er Ke Za Zhi. 2015 Dec;53(12):931-7. Chinese.
- Results Burkhardt B, Woessmann W, Zimmermann M, Kontny U, Vormoor J, Doerffel W, Mann G, Henze G, Niggli F, Ludwig WD, Janssen D, Riehm H, Schrappe M, Reiter A. Impact of cranial radiotherapy on central nervous system prophylaxis in children and adolescents with central nervous system-negative stage III or IV lymphoblastic lymphoma. J Clin Oncol. 2006 Jan 20;24(3):491-9. doi: 10.1200/JCO.2005.02.2707.
- Results Widjajanto PH, Sumadiono S, Purwanto I, Sutaryo S, Veerman AJ. L-asparaginase: long-term results of a randomized trial of the effect of additional 3 doses during consolidation treatment in the Indonesian WK-ALL-2000 protocol. J Pediatr Hematol Oncol. 2013 Nov;35(8):597-602. doi: 10.1097/MPH.0b013e31827e7f89.
- Yu Q, Wang G, Wang J, Zhang W, Meng L, Cao Y. Primary Testicular and Cutaneous Philadelphia Chromosome Positive B-Cell Lymphoblastic Lymphoma: A Rare Case and Review. Cancer Manag Res. 2022 Apr 21;14:1507-1514. doi: 10.2147/CMAR.S353022. eCollection 2022.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 200 mg/m2 | — |
| Subject | Cyclophosphamide | Other / unclassified | 1000 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 75 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 2000 mg/m2 | — |
| Subject | Daunorubicin | Small molecule | 25 mg/m2 | — |
| Subject | Daunorubicin | Small molecule | 30 mg/m2 | — |
| Subject | Dexamethasone | Small molecule | 10 mg/m2 | — |
| Subject | Dexamethasone | Small molecule | 20 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 30 mg/m2 | — |
| Subject | Etoposide | Small molecule | 100 mg/m2 | — |
| Subject | Ifosfamide | Small molecule | 800 mg/m2 | — |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | 25 mg/m2 | — |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | 50 mg/m2 | — |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | 60 mg/m2 | — |
| Subject | Methotrexate | Small molecule | 20 mg/m2 | — |
| Subject | Methotrexate | Small molecule | 5 g | — |
| Subject | Methotrexate | Small molecule | 5000 mg/m2 | — |
| Subject | Pegylated asparaginase | Unknown | 2000 unknown | — |
| Subject | Prednisone | Other / unclassified | 60 mg/m2 | — |
| Subject | Vincristine | Small molecule | 1.5 mg/m2 | — |
| Subject | Vindesine | Small molecule | 3 mg/m2 | — |