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临床试验/NCT04043494
NCT04043494招募中3 期

LBL 2018 - International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

University Hospital Muenster439 个研究点 分布在 7 个国家目标入组 683 人开始时间: 2019年8月23日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
683
试验地点
439
主要终点
Cumulative incidence of relapse with involvement of the CNS (CNS-relapse, pCICR)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Primary objectives:

  • Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm)
  • Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02)

详细描述

The trial LBL 2018 is a collaborative prospective, multi-national, multi-center, randomized clinical trial for the treatment of children and adolescents with newly diagnosed lymphoblastic lymphoma.

The LBL 2018 trial will be open for the qualified centers of following participating study Groups (core study cohort): AIEOP (Italy), BFM (Austria, Czech Republic, Germany, Switzerland), BSPHO (Belgium), CoALL (Germany), DCOG (The Netherlands), NOPHO (Denmark, Finland, Norway, Sweden), PPLLSG (Poland), SEHOP (Spain) and SFCE (France). HKPHOSG (Hong Kong), HPOG (Hungary), ISPHO (Israel), NSPHO (Moscow), SHOP (Portugal) and SPS (Slovak Republic) start patient recruitment into the extended study cohort (without randomization). Over the trial period study groups may switch from the extended study cohort to the core study cohort.

Primary objectives:

  • Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm)
  • Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02)

Patients are stratified into 3 different risk groups according to CNS status, immunophenotype, genetic markers and stage of disease at diagnosis: high risk group (HR), standard risk group I/II (SR I/II) and standard risk group (SR).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 18 Years（Child, Adult）
性别
All
接受健康志愿者
否

入选标准

  • •newly diagnosed lymphoblastic lymphoma
  • •age <18 years
  • •patient enrolled in a participating center
  • •written informed consent of patient (>14 years of age or according to local law and regulation) and parents to trial participation and transfer and processing of data
  • •willingness of patients and the investigator/pathologist to provide adequate slides/blocks for reference (molecular) pathology and international pathology panel and/or fresh or fresh frozen samples for genetic risk group stratification if these samples are available after standard diagnostic procedures.

排除标准

  • •lymphoblastic lymphoma as secondary malignancy
  • •non-lymphoma related relevant medical, psychiatric or social conditions incompatible with trial treatment, including among others
  • •prior organ transplant
  • •severe immunodeficiency
  • •demyelinating Charcot-Marie Tooth syndrome
  • •serious acute or chronic infections, such as HIV, VZV and tuberculosis
  • •urinary tract infection, cystitis, urinary outflow obstruction, severe renal impairment (creatinine clearance less than 20 ml/min)
  • •severe hepatic impairment (bilirubin >3 times ULN, transaminases >10 times ULN)
  • •myocardial insufficiency, severe arrhythmias
  • •ulcers of the oral cavity and known active gastrointestinal ulcer disease
  • •known hypersensitivity to any IMP and to any excipient (listed in section 6.1 of the respective SmPC)
  • •steroid pre-treatment with ≥ 1 mg/kg/d for more than two weeks during the last month before diagnosis
  • •vaccination with live vaccines within 2 weeks before start of protocol treatment
  • •treatment started according to another protocol or pre-treatment with cytostatic drugs
  • •participation in another clinical trial that interferes with the protocol, except NHL-BFM Registry 2012 and trials with different endpoints, involving aspects of supportive treatment, which can run parallel to LBL 2018 without influencing the outcome of this trial (e.g. trials on antiemetics, antibiotics, strategies for psychosocial support)
  • •evidence of pregnancy or lactation period
  • •sexually active adolescents not willing to use highly effective contraceptive method (pearl index < 1) until 12 months after end of cytostatic therapy

研究组 & 干预措施

SR I/II: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. maintenance therapy

干预措施: Cyclophosphamide (Drug)

SR I/II: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. maintenance therapy

干预措施: PEG asparaginase (Drug)

SR I/II: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment Phase (protocol M)
  5. maintenance therapy

干预措施: Cyclophosphamide (Drug)

SR I/II: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment Phase (protocol M)
  5. maintenance therapy

干预措施: Cytarabine (Drug)

SR I/II: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment Phase (protocol M)
  5. maintenance therapy

干预措施: Dexamethasone (Drug)

SR I/II: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment Phase (protocol M)
  5. maintenance therapy

干预措施: Daunorubicin (Drug)

SR I/II: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment Phase (protocol M)
  5. maintenance therapy

干预措施: 6-Mercaptopurine (Drug)

SR: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: 6-Mercaptopurine (Drug)

HR: R1 into "Pred" and R2 into non-HR extra-compartment phase

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Doxorubicin (Drug)

HR: R1 into "Pred" and R2 into non-HR extra-compartment phase

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Prednisone (Drug)

HR: R1 into "Pred" and R2 into non-HR extra-compartment phase

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Prednisolone (Drug)

HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Dexamethasone (Drug)

HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: 6-Mercaptopurine (Drug)

HR: R1 into "Pred" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: PEG asparaginase (Drug)

HR: R1 into "Pred" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: 6-Mercaptopurine (Drug)

HR: R1 into "Pred" and R2 into non-HR extra-compartment phase

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: PEG asparaginase (Drug)

SR I/II: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment Phase (protocol M)
  5. maintenance therapy

干预措施: PEG asparaginase (Drug)

SR: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: PEG asparaginase (Drug)

SR: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: PEG asparaginase (Drug)

HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: PEG asparaginase (Drug)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: PEG asparaginase (Drug)

SR I/II: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. maintenance therapy

干预措施: Cytarabine (Drug)

SR I/II: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. maintenance therapy

干预措施: Daunorubicin (Drug)

SR I/II: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. maintenance therapy

干预措施: 6-Mercaptopurine (Drug)

SR I/II: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. maintenance therapy

干预措施: Methotrexate (Drug)

SR I/II: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. maintenance therapy

干预措施: Prednisone (Drug)

SR I/II: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. maintenance therapy

干预措施: Prednisolone (Drug)

SR I/II: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. maintenance therapy

干预措施: Vincristine (Drug)

SR I/II: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment Phase (protocol M)
  5. maintenance therapy

干预措施: Methotrexate (Drug)

SR I/II: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment Phase (protocol M)
  5. maintenance therapy

干预措施: Prednisone (Drug)

SR I/II: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment Phase (protocol M)
  5. maintenance therapy

干预措施: Prednisolone (Drug)

SR I/II: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment Phase (protocol M)
  5. maintenance therapy

干预措施: Vincristine (Drug)

SR: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Cyclophosphamide (Drug)

SR: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Dexamethasone (Drug)

SR: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Cytarabine (Drug)

SR: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Daunorubicin (Drug)

SR: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Methotrexate (Drug)

SR: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Prednisolone (Drug)

SR: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Doxorubicin (Drug)

SR: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: 6-Mercaptopurine (Drug)

SR: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Prednisone (Drug)

SR: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Thioguanine (Drug)

SR: R1 into protocol Ia-Pred

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Vincristine (Drug)

SR: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Cyclophosphamide (Drug)

SR: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Cytarabine (Drug)

SR: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Doxorubicin (Drug)

SR: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Dexamethasone (Drug)

SR: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Daunorubicin (Drug)

SR: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Methotrexate (Drug)

SR: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Prednisone (Drug)

SR: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Thioguanine (Drug)

SR: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Prednisolone (Drug)

HR: R1 into "Pred" and R2 into non-HR extra-compartment phase

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Cyclophosphamide (Drug)

SR: R1 into protocol Ia-Dexa

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Vincristine (Drug)

HR: R1 into "Pred" and R2 into non-HR extra-compartment phase

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Daunorubicin (Drug)

HR: R1 into "Pred" and R2 into non-HR extra-compartment phase

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Cytarabine (Drug)

HR: R1 into "Pred" and R2 into non-HR extra-compartment phase

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Dexamethasone (Drug)

HR: R1 into "Pred" and R2 into non-HR extra-compartment phase

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: 6-Mercaptopurine (Drug)

HR: R1 into "Pred" and R2 into non-HR extra-compartment phase

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Methotrexate (Drug)

HR: R1 into "Pred" and R2 into non-HR extra-compartment phase

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Thioguanine (Drug)

HR: R1 into "Pred" and R2 into non-HR extra-compartment phase

Other
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Vincristine (Drug)

HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Cytarabine (Drug)

HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Cyclophosphamide (Drug)

HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Daunorubicin (Drug)

HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Doxorubicin (Drug)

HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Methotrexate (Drug)

HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Prednisone (Drug)

HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Prednisolone (Drug)

HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Thioguanine (Drug)

HR: R1 into "Pred" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Cyclophosphamide (Drug)

HR: R1 into "Pred" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Cytarabine (Drug)

HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib)
  4. non-HR extra-compartment phase (protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Vincristine (Drug)

HR: R1 into "Pred" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Dexamethasone (Drug)

HR: R1 into "Pred" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Doxorubicin (Drug)

HR: R1 into "Pred" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Daunorubicin (Drug)

HR: R1 into "Pred" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Ifosfamide (Drug)

HR: R1 into "Pred" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Methotrexate (Drug)

HR: R1 into "Pred" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Prednisone (Drug)

HR: R1 into "Pred" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Prednisolone (Drug)

HR: R1 into "Pred" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Vincristine (Drug)

HR: R1 into "Pred" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Thioguanine (Drug)

HR: R1 into "Pred" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. standard induction phase (protocol Ia-prednisone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Vindesine (Drug)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Cytarabine (Drug)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Cyclophosphamide (Drug)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Dexamethasone (Drug)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: 6-Mercaptopurine (Drug)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Doxorubicin (Drug)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Daunorubicin (Drug)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Methotrexate (Drug)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Ifosfamide (Drug)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Prednisone (Drug)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Prednisolone (Drug)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Vindesine (Drug)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Thioguanine (Drug)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase

Experimental
  1. cytoreductive prephase with prednisone
  2. experimental induction phase (protocol Ia-dexamethasone)
  3. consolidation phase (protocol Ib*)
  4. HR extra-compartment phase (intensified protocol M)
  5. reintensification phase (protocol II)
  6. maintenance therapy

干预措施: Vincristine (Drug)

结局指标

主要结局

Cumulative incidence of relapse with involvement of the CNS (CNS-relapse, pCICR)

时间窗: through study completion, maximal 7.25 years

The time to relapse is defined as the time from randomization to the first relapse or the date of last follow-up. Other events (non-response, progressive disease, relapse, second malignancy or death before and in CR) will be taken into account as competing events.

Estimated probability of event-free survival (pEFS)

时间窗: through study completion, maximal 7.25 years

The pEFS is defined as the time from randomization to the first event (non-response, progressive disease, relapse, second malignancy or death from any cause) or date of last follow-up.

次要结局

  • Survival (pOS)(through study completion, maximal 7.25 years)
  • Frequency of treatment-related toxicity overall and in specific protocol elements, randomized arms and during follow up(through study completion, maximal 7.25 years)
  • Frequency of treatment-related mortality overall and in specific protocol elements, randomized arms and during follow up(through study completion, maximal 7.25 years)
  • Frequency of adverse events of interest and severe adverse events overall(through study completion, maximal 7.25 years)
  • Cumulative incidence of relapses in association with molecular markers(through study completion, maximal 7.25 years)
  • Cumulative incidence of relapses in association with minimal residual disease results(through study completion, maximal 7.25 years)
  • Rate of evaluable patients for risk group stratification(during recruitment)

研究者

发起方
University Hospital Muenster
申办方类型
Other
责任方
Sponsor

研究点 (439)

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