Lymphoblastic LymphomaPhase 3NCT02845882
LBL-2016 for Children or Adolescents in China
A Phase 3 study testing Prednisone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, 6-mercaptopurine,Methotrexate and Dexamethasone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Doxorubicin, 6-mercaptopurine in people with Lymphoblastic Lymphoma, run by Children's Cancer Group, China at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 months to 18 years
- Conditions the study is for
- Lymphoblastic Lymphoma
- What is being tested?
- Prednisone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, 6-mercaptopurine,Methotrexate and Dexamethasone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Doxorubicin, 6-mercaptopurine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2016to Dec 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must have newly diagnosed lymphoblastic lymphoma; Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids (<420mg/m2)
Who cannot join
- Patients with Down syndrome;
- Morphologically unclassifiable lymphoma
- Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology.
- Evidence of pregnancy or lactation period.
- Ph+ lymphoblastic lymphoma
Trial locations and contacts
2 sites in 1 country.
China2 sites
West China Second University Hospital
Chengdu
Shanghai Children's Medical Center
Shanghai, 200127
About this study
Official title: Modified BFM (Berlin-Frankfurt-Munster)Backbone Therapy for Chinese Children or Adolescents With Newly Diagnosed Lymphoblastic Lymphoma
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.
Read the detailed description
The treatment for LBL is an ALL (acute lymphoblastic leukemia)-based treatment. Additional, high dose L-asparaginase was reported to improve disease-free survival for patients with ALL. The event free survival (EFS) for pediatric LBL in most western countries have achieved 75% to 85%. However, the outcomes of children with LBL in China were not unexpected. In the previous study (CCCG-LBL-2010, 2009-2013), 96 patients with newly diagnosed LBL from 7 Chinese pediatric oncology centers were included. At a median follow-up of 21 months (range, 0.3~60.7months), the 2-year event free survival was 68±5% in all patients. Patients who had achieved complete remission on day 33 of induction had significantly better EFS than those who had not (77±6% v.s.17±10%, p<0.005). In the current trial, the investigators try to improve survival for children with LBL in China through further modification treatment protocols and strengthen domestic multicenter collaboration.
The BFM backbone will be used as the standard backbone therapy for this study. Three doses of daunorubicin are prescribed in induction compared with 4 doses in BFM studies. Cranial radiotherapy only saved for patients (>2 yrs) with CNS disease at presentation.
Complete remission (CR) is defined as at least 75% tumor regression, less than 5% BM (bone marrow)blasts, no CNS (central nervous system) disease, and disappearances of all evidence of disease from all sites for at least 4 weeks. Partial response (PR) is defined as > 50% tumor regression, and no new lesions.Response to treatment is evaluated on day 33 and day 64 of induction.Patients will be stratified into 3 risk groups.
Low risk group: patients (stage I or II) receive induction protocol I followed by the extracompartmental protocol M, and maintenance for up to a total therapy duration of 96 weeks. Totally, 3 doses of PEG-asparaginase (Pegylated-asparaginase) are applied in this group.
Intermediate risk group: patients (stage III or IV or receiving steroids within one week prior to the diagnosis) receive induction protocol I followed by the extracompartmental protocol M, reintensification protocol II, and maintenance for up to a total therapy duration of 104 weeks.Totally, 5 doses of PEG-asparaginase are applied in this group.
High risk group:patients (failure to qualify a PR, or >5% BM blasts, or with CNS disease on d33 of induction) receive induction protocol I followed by 6 intensive polychemotherapy blocks (R'), reintensification protocol II, and maintenance for up to a total therapy duration of 104 weeks. Totally, 11 doses of PEG-asparaginase are applied in this group.
Second look biopsy/resection is indicated for patients without CR on day 64 of induction. Allo- or auto-hematopoietic stem-cell transplantation is recommended for patients with residual tumor. Patients who have disease progression at any time will be removed from this protocol therapy.
- Conditions
- Lymphoblastic Lymphoma
- Being tested
- Prednisone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, 6-mercaptopurine,Methotrexate, Dexamethasone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Doxorubicin, 6-mercaptopurine, Dexamethasone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Methotrexate, Dexamethasone, Vindesine, Methotrexate, Ifosfamide, Daunorubicin, Pegylated-asparaginase
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurineDrug
Also called Induction I
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
Also called Protocol M
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
Also called Reinduction II
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
Also called HR 1'
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
Also called HR 2'
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
Also called HR 3'
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
Also called maintenance therapy
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;
| Study group | Role | What they receive |
|---|---|---|
| Low risk group | Other | Stage I or II: Induction I followed by extracompartmental Protocol M, and maintenance therapy for up to a total therapy duration of 96 weeks. Twenty triple intrathecal injections. Receives: Drug: Prednisone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine; Drug: 6-mercaptopurine,Methotrexate; Drug: Methotrexate, 6-mercaptopurine |
| Intermediate risk group | Other | Stage III or IV or receiving steroids within one week prior to the diagnosis: Induction protocol I followed by the extracompartmental protocol M, reintensification protocol II, and maintenance therapy for up to a total therapy duration of 104 weeks. Twenty-two triple intrathecal injections. Receives: Drug: Prednisone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine; Drug: 6-mercaptopurine,Methotrexate; Drug: Dexamethasone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Doxorubicin, 6-mercaptopurine; Drug: Methotrexate, 6-mercaptopurine |
| High risk group | Other | Failure to qualify a PR, or >5% BM blasts, or with CNS disease on d33 of induction: Induction protocol I followed by 6 intensive polychemotherapy blocks (HR1'-HR2'-HR3'-HR1'-HR2'-HR3'), reintensification protocol II, and maintenance therapy for up to a total therapy duration of 104 weeks. Twenty-two triple intrathecal injections. Receives: Drug: Prednisone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine; Drug: Dexamethasone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Doxorubicin, 6-mercaptopurine; Drug: Dexamethasone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Methotrexate; Drug: Dexamethasone, Vindesine, Methotrexate, Ifosfamide, Daunorubicin, Pegylated-asparaginase; Drug: Dexamethasone, Cytarabine, Etoposide, Pegylated-asparaginase; Drug: Methotrexate, 6-mercaptopurine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival for the whole cohort
Measured: 3 years
Event free survival for patients in High risk group
Measured: 3 years
Secondary outcomes (1)
Overall survival for all patients
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startJan 2016
- Primary completion31 Dec 2023
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Lymphoblastic LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer Group, China
- Sponsor type
- Research network
- Collaborators
- Shanghai 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
- Responsible party
- Sponsor
- Investigators
- Yi-Jin Gao, M.D., Principal investigator, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845882
- Sponsor's protocol ID
- CCCG-LBL-2016
- Status last verified
- Mar 2026
- First submitted
- 24 Jul 2016
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19433688Reiter 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.
PubMed 10627444Moghrabi 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.
PubMed 17003366Stary 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.
PubMed 24344215Lymphoma 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.
PubMed 26887549Burkhardt 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.
PubMed 16421426Widjajanto 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.
PubMed 23389497Yu 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.
PubMed 35478711
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified BFM (Berlin-Frankfurt-Munster)Backbone Therapy for Chinese Children or Adolescents With Newly Diagnosed Lymphoblastic Lymphoma
- ClinicalTrials.gov ID
- NCT02845882
- Acronym / sponsor ID
- CCCG-LBL-2016
- Conditions
- Lymphoblastic Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Children's Cancer Group, ChinaResearch network
- Collaborators
- Shanghai 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
- Study start
- Jan 2016 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- Dec 2031 (estimated)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The treatment for LBL is an ALL (acute lymphoblastic leukemia)-based treatment. Additional, high dose L-asparaginase was reported to improve disease-free survival for patients with ALL. The event free survival (EFS) for pediatric LBL in most western countries have achieved 75% to 85%. However, the outcomes of children with LBL in China were not unexpected. In the previous study (CCCG-LBL-2010, 2009-2013), 96 patients with newly diagnosed LBL from 7 Chinese pediatric oncology centers were included. At a median follow-up of 21 months (range, 0.3~60.7months), the 2-year event free survival was 68±5% in all patients. Patients who had achieved complete remission on day 33 of induction had significantly better EFS than those who had not (77±6% v.s.17±10%, p<0.005). In the current trial, the investigators try to improve survival for children with LBL in China through further modification treatment protocols and strengthen domestic multicenter collaboration.
The BFM backbone will be used as the standard backbone therapy for this study. Three doses of daunorubicin are prescribed in induction compared with 4 doses in BFM studies. Cranial radiotherapy only saved for patients (>2 yrs) with CNS disease at presentation.
Complete remission (CR) is defined as at least 75% tumor regression, less than 5% BM (bone marrow)blasts, no CNS (central nervous system) disease, and disappearances of all evidence of disease from all sites for at least 4 weeks. Partial response (PR) is defined as > 50% tumor regression, and no new lesions.Response to treatment is evaluated on day 33 and day 64 of induction.Patients will be stratified into 3 risk groups.
Low risk group: patients (stage I or II) receive induction protocol I followed by the extracompartmental protocol M, and maintenance for up to a total therapy duration of 96 weeks. Totally, 3 doses of PEG-asparaginase (Pegylated-asparaginase) are applied in this group.
Intermediate risk group: patients (stage III or IV or receiving steroids within one week prior to the diagnosis) receive induction protocol I followed by the extracompartmental protocol M, reintensification protocol II, and maintenance for up to a total therapy duration of 104 weeks.Totally, 5 doses of PEG-asparaginase are applied in this group.
High risk group:patients (failure to qualify a PR, or >5% BM blasts, or with CNS disease on d33 of induction) receive induction protocol I followed by 6 intensive polychemotherapy blocks (R'), reintensification protocol II, and maintenance for up to a total therapy duration of 104 weeks. Totally, 11 doses of PEG-asparaginase are applied in this group.
Second look biopsy/resection is indicated for patients without CR on day 64 of induction. Allo- or auto-hematopoietic stem-cell transplantation is recommended for patients with residual tumor. Patients who have disease progression at any time will be removed from this protocol therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low risk group | Other | Drug: Prednisone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, Drug: 6-mercaptopurine,Methotrexate, Drug: Methotrexate, 6-mercaptopurineStage I or II: Induction I followed by extracompartmental Protocol M, and maintenance therapy for up to a total therapy duration of 96 weeks. Twenty triple intrathecal injections. |
| Intermediate risk group | Other | Drug: Prednisone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, Drug: 6-mercaptopurine,Methotrexate, Drug: Dexamethasone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Doxorubicin, 6-mercaptopurine, Drug: Methotrexate, 6-mercaptopurineStage III or IV or receiving steroids within one week prior to the diagnosis: Induction protocol I followed by the extracompartmental protocol M, reintensification protocol II, and maintenance therapy for up to a total therapy duration of 104 weeks. Twenty-two triple intrathecal injections. |
| High risk group | Other | Drug: Prednisone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, Drug: Dexamethasone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Doxorubicin, 6-mercaptopurine, Drug: Dexamethasone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Methotrexate, Drug: Dexamethasone, Vindesine, Methotrexate, Ifosfamide, Daunorubicin, Pegylated-asparaginase, Drug: Dexamethasone, Cytarabine, Etoposide, Pegylated-asparaginase, Drug: Methotrexate, 6-mercaptopurineFailure to qualify a PR, or >5% BM blasts, or with CNS disease on d33 of induction: Induction protocol I followed by 6 intensive polychemotherapy blocks (HR1'-HR2'-HR3'-HR1'-HR2'-HR3'), reintensification protocol II, and maintenance therapy for up to a total therapy duration of 104 weeks. Twenty-two triple intrathecal injections. |
Who may qualify
- Ages
- 12 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients must have newly diagnosed lymphoblastic lymphoma; Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids (<420mg/m2)
Key exclusion criteria (5 listed)
- Patients with Down syndrome;
- Morphologically unclassifiable lymphoma
- Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology.
- Evidence of pregnancy or lactation period.
- Ph+ lymphoblastic lymphoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurineAlso: Induction IPrednisone 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 | Drug | High risk group, Intermediate risk group, Low risk group |
| 6-mercaptopurine,MethotrexateAlso: Protocol M6-Mercaptopurine 25 mg/m2 per day, d1-56; Methotrexate 5g/m2 per dose, d1, 15, 29, 43; Triple it, d1, 15, 29, 43; | Drug | Intermediate risk group, Low risk group |
| Dexamethasone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Doxorubicin, 6-mercaptopurineAlso: Reinduction IIDexamethasone 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; | Drug | High risk group, Intermediate risk group |
| Dexamethasone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, MethotrexateAlso: HR 1'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; | Drug | High risk group |
| Dexamethasone, Vindesine, Methotrexate, Ifosfamide, Daunorubicin, Pegylated-asparaginaseAlso: HR 2'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; | Drug | High risk group |
| Dexamethasone, Cytarabine, Etoposide, Pegylated-asparaginaseAlso: HR 3'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; | Drug | High risk group |
| Methotrexate, 6-mercaptopurineAlso: maintenance therapy6-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; | Drug | High risk group, Intermediate risk group, Low risk group |
Primary outcome
Event free survival for the whole cohort
Time frame: 3 years
Event free survival for patients in High risk group
Time frame: 3 years
1 secondary outcome
Overall survival for all patients
Time frame: 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Results publication: PubMed 19433688Burkhardt 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 publication: PubMed 10627444Reiter 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 publication: PubMed 17003366Moghrabi 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 publication: PubMed 24344215Stary 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 publication: PubMed 26887549Lymphoma 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 publication: PubMed 16421426Burkhardt 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 publication: PubMed 23389497Widjajanto 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.
- Derived from this study: PubMed 35478711Yu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Jin Gao, M.D. principal investigator
Shanghai Children's Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prednisone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, 6-mercaptopurine,Methotrexate and Dexamethasone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Doxorubicin, 6-mercaptopurine in people with Lymphoblastic Lymphoma, run by Children's Cancer Group, China at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event free survival for the whole cohort (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02845882, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.