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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04043494
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : September 30, 2020
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
University Hospital Muenster

Brief Summary:

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)

Condition or disease Intervention/treatment Phase
Lymphoblastic Lymphoma, Childhood Drug: Cyclophosphamide Drug: Cytarabine Drug: Dexamethasone Drug: Daunorubicin Drug: Doxorubicin Drug: Ifosfamide Drug: 6-Mercaptopurine Drug: Methotrexate Drug: PEG asparaginase Drug: Prednisone Drug: Prednisolone Drug: Thioguanine Drug: Vincristine Drug: Vindesine Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 683 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LBL 2018 - International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
Actual Study Start Date : August 23, 2019
Estimated Primary Completion Date : October 31, 2027
Estimated Study Completion Date : October 31, 2027


Arm Intervention/treatment
SR I/II: R1 into protocol Ia-Pred
  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
Drug: Cyclophosphamide
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Cytarabine

No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2).

Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)


Drug: Daunorubicin
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Methotrexate
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: PEG asparaginase
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib* (Randomization R2)

Drug: Prednisone
Part of standard chemotherapy

Drug: Prednisolone
No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2

Drug: Vincristine
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Experimental: SR I/II: R1 into protocol Ia-Dexa
  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
Drug: Cyclophosphamide
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Cytarabine

No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2).

Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)


Drug: Dexamethasone
Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)

Drug: Daunorubicin
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Methotrexate
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: PEG asparaginase
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib* (Randomization R2)

Drug: Prednisone
Part of standard chemotherapy

Drug: Prednisolone
No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2

Drug: Vincristine
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

SR: R1 into protocol Ia-Pred
  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
Drug: Cyclophosphamide
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Cytarabine

No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2).

Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)


Drug: Dexamethasone
Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)

Drug: Daunorubicin
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Doxorubicin
Part of standard chemotherapy

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Methotrexate
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: PEG asparaginase
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib* (Randomization R2)

Drug: Prednisone
Part of standard chemotherapy

Drug: Prednisolone
No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2

Drug: Thioguanine
Part of standard chemotherapy

Drug: Vincristine
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Experimental: SR: R1 into protocol Ia-Dexa
  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
Drug: Cyclophosphamide
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Cytarabine

No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2).

Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)


Drug: Dexamethasone
Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)

Drug: Daunorubicin
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Doxorubicin
Part of standard chemotherapy

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Methotrexate
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: PEG asparaginase
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib* (Randomization R2)

Drug: Prednisone
Part of standard chemotherapy

Drug: Prednisolone
No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2

Drug: Thioguanine
Part of standard chemotherapy

Drug: Vincristine
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

HR: R1 into "Pred" and R2 into non-HR extra-compartment phase
  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
Drug: Cyclophosphamide
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Cytarabine

No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2).

Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)


Drug: Dexamethasone
Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)

Drug: Daunorubicin
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Doxorubicin
Part of standard chemotherapy

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Methotrexate
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: PEG asparaginase
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib* (Randomization R2)

Drug: Prednisone
Part of standard chemotherapy

Drug: Prednisolone
No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2

Drug: Thioguanine
Part of standard chemotherapy

Drug: Vincristine
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Experimental: HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase
  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
Drug: Cyclophosphamide
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Cytarabine

No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2).

Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)


Drug: Dexamethasone
Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)

Drug: Daunorubicin
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Doxorubicin
Part of standard chemotherapy

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Methotrexate
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: PEG asparaginase
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib* (Randomization R2)

Drug: Prednisone
Part of standard chemotherapy

Drug: Prednisolone
No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2

Drug: Thioguanine
Part of standard chemotherapy

Drug: Vincristine
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Experimental: HR: R1 into "Pred" and R2 into HR extra-compartment phase
  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
Drug: Cyclophosphamide
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Cytarabine

No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2).

Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)


Drug: Dexamethasone
Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)

Drug: Daunorubicin
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Doxorubicin
Part of standard chemotherapy

Drug: Ifosfamide
Part of the experimental therapy in Randomization R2 (Intensified Protocol M)

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Methotrexate
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: PEG asparaginase
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib* (Randomization R2)

Drug: Prednisone
Part of standard chemotherapy

Drug: Prednisolone
No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2

Drug: Thioguanine
Part of standard chemotherapy

Drug: Vincristine
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Vindesine
Part of the experimental therapy in Randomization R2 (Intensified Protocol M)

Experimental: HR: R1 into "Dexa" and R2 into HR extra-compartment phase
  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
Drug: Cyclophosphamide
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Cytarabine

No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2).

Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)


Drug: Dexamethasone
Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)

Drug: Daunorubicin
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Doxorubicin
Part of standard chemotherapy

Drug: Ifosfamide
Part of the experimental therapy in Randomization R2 (Intensified Protocol M)

Drug: 6-Mercaptopurine
Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Methotrexate
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: PEG asparaginase
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib* (Randomization R2)

Drug: Prednisone
Part of standard chemotherapy

Drug: Prednisolone
No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2

Drug: Thioguanine
Part of standard chemotherapy

Drug: Vincristine
Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Drug: Vindesine
Part of the experimental therapy in Randomization R2 (Intensified Protocol M)




Primary Outcome Measures :
  1. Cumulative incidence of relapse with involvement of the CNS (CNS-relapse, pCICR) [ Time Frame: 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.

  2. Estimated probability of event-free survival (pEFS) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Survival (pOS) [ Time Frame: through study completion, maximal 7.25 years ]
    Survival (pOS) is defined as time from diagnosis to death due to any cause or to the date of last contact for patients alive

  2. Frequency of treatment-related toxicity overall and in specific protocol elements, randomized arms and during follow up [ Time Frame: through study completion, maximal 7.25 years ]
  3. Frequency of treatment-related mortality overall and in specific protocol elements, randomized arms and during follow up [ Time Frame: through study completion, maximal 7.25 years ]
  4. Frequency of adverse events of interest and severe adverse events overall [ Time Frame: through study completion, maximal 7.25 years ]
  5. Rate of evaluable patients for risk group stratification [ Time Frame: during recruitment ]
  6. Cumulative incidence of relapses in association with molecular markers [ Time Frame: through study completion, maximal 7.25 years ]
  7. Cumulative incidence of relapses in association with minimal residual disease results [ Time Frame: through study completion, maximal 7.25 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04043494


Contacts
Layout table for location contacts
Contact: Birgit Burkhardt, Prof. Dr. Dr. +49 251 83 55696 LBL2018@ukmuenster.de

Locations
Show Show 223 study locations
Sponsors and Collaborators
University Hospital Muenster
Deutsche Krebshilfe e.V., Bonn (Germany)
Investigators
Layout table for investigator information
Principal Investigator: Birgit Burkhardt, Prof. Dr. Dr. University Hospital Muenster, Klinik für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie
Layout table for additonal information
Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT04043494    
Other Study ID Numbers: UKM17_0023
2017-001691-39 ( EudraCT Number )
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia
Cytarabine
Dexamethasone
Prednisone
Prednisolone
Cyclophosphamide
Ifosfamide
Doxorubicin
Methotrexate
Vincristine
Daunorubicin
Asparaginase
Mercaptopurine
Thioguanine
Pegaspargase
Vindesine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents