A Phase 3 interventional study of Cyclophosphamide and Cytarabine in Lymphoblastic Lymphoma, Childhood, sponsored by University Hospital Muenster. Recruiting at 228 sites in 21 countries. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by University Hospital Muenster · Phase 3, Interventional, and Treatment
Primary objectives:
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:
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).
Patients in the risk groups SR I/II and SR are randomized (R1) in two arms after a cytoreductive prephase with prednisone. Patients in standard arm receive the standard induction phase with prednisone. Patients in the experimental arm receive an induction phase with dexamethasone instead of prednisone.
In SR group, induction phase is followed by the consolidation phase, the non-HR extra-compartment phase with HD-MTX (high-dose methotrexate), the reintensification phase and the maintenance therapy for the total therapy duration of 24 months. In SR I/II group, patients receive no reintensification phase. The Induction phase is followed by the consolidation phase, the non-HR extra-compartment phase and the maintenance therapy for the total therapy duration of 24 months.
Patients in the HR group are eligible for randomization (R1) as outlined above. In addition high risk patients are eligible for second randomization (R2) at the end of induction phase. In the standard arm, HR-patients receive the consolidation phase and the non-HR extra-compartment phase. In the experimental arm, HR-patients receive a consolidation phase including two additional doses of PEG asparaginase and the HR-intensified extra-compartment phase consisting of two high risk courses alternating with two HD-MTX courses. Either phase is followed by the reintensification phase and the maintenance therapy for the total therapy duration of 24 months.
Patients with involvement of the CNS (CNS positive) are stratified to the high risk group (HR) and are eligible for both randomizations (R1 and R2). Additionally, patients with CNS involvement (CNS positive) receive intensified intrathecal therapy. Intrathecal therapy consists of TIT (triple intrathecal therapy) after diagnosis of CNS involvement. TIT is administered twice weekly until clearance of blasts in the cerebrospinal fluid is achieved. Further intrathecal therapy is provided at the same points of time as for patients without CNS involvement, but TIT instead of MTX IT. In addition, patients receive four additional doses of TIT during maintenance. Cranial irradiation is omitted for patients with CNS involvement.
2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.
This study's planned enrollment of 683 is above the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →University Hospital Muenster is the lead sponsor of 192 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
non-lymphoma related relevant medical, psychiatric or social conditions incompatible with trial treatment, including among others
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Drug: Cytarabine · Drug: Daunorubicin · Drug: 6-Mercaptopurine · Drug: Methotrexate · Drug: PEG asparaginase · Drug: Prednisone · Drug: Prednisolone · Drug: Vincristine
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 · Drug: Cytarabine · Drug: Dexamethasone · Drug: Daunorubicin · Drug: 6-Mercaptopurine · Drug: Methotrexate · Drug: PEG asparaginase · Drug: Prednisone · Drug: Prednisolone · Drug: Vincristine
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 · Drug: Cytarabine · Drug: Dexamethasone · Drug: Daunorubicin · Drug: Doxorubicin · Drug: 6-Mercaptopurine · Drug: Methotrexate · Drug: PEG asparaginase · Drug: Prednisone · Drug: Prednisolone · Drug: Thioguanine · Drug: Vincristine
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 · Drug: Cytarabine · Drug: Dexamethasone · Drug: Daunorubicin · Drug: Doxorubicin · Drug: 6-Mercaptopurine · Drug: Methotrexate · Drug: PEG asparaginase · Drug: Prednisone · Drug: Prednisolone · Drug: Thioguanine · Drug: Vincristine
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 · Drug: Cytarabine · Drug: Dexamethasone · Drug: Daunorubicin · Drug: Doxorubicin · Drug: 6-Mercaptopurine · Drug: Methotrexate · Drug: PEG asparaginase · Drug: Prednisone · Drug: Prednisolone · Drug: Thioguanine · Drug: Vincristine
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 · Drug: Cytarabine · Drug: Dexamethasone · Drug: Daunorubicin · Drug: Doxorubicin · Drug: 6-Mercaptopurine · Drug: Methotrexate · Drug: PEG asparaginase · Drug: Prednisone · Drug: Prednisolone · Drug: Thioguanine · Drug: Vincristine
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 · 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
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 · 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
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)
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)
Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)
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)
Part of standard chemotherapy
Part of the experimental therapy in Randomization R2 (Intensified Protocol M)
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)
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)
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)
Part of standard chemotherapy
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
Part of standard chemotherapy
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)
Part of the experimental therapy in Randomization R2 (Intensified Protocol M)
Cumulative incidence of relapse with involvement of the CNS (CNS-relapse, pCICR)
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.
Time frame: through study completion, maximal 7.25 years
Estimated probability of event-free survival (pEFS)
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.
Time frame: through study completion, maximal 7.25 years
Survival (pOS)
Survival (pOS) is defined as time from diagnosis to death due to any cause or to the date of last contact for patients alive
Time frame: through study completion, maximal 7.25 years
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
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
Frequency of adverse events of interest and severe adverse events overall
Time frame: through study completion, maximal 7.25 years
Rate of evaluable patients for risk group stratification
Time frame: during recruitment
Cumulative incidence of relapses in association with molecular markers
Time frame: through study completion, maximal 7.25 years
Cumulative incidence of relapses in association with minimal residual disease results
Time frame: through study completion, maximal 7.25 years
Showing the first 100 of 228 sites across 21 countries. Choose a country and city above to see the rest.
Plan to share: No
Started Aug 2019 (actual). Primary completion is estimated for Apr 2030, 127 months after the start.
Of 43 non-industry phase 3 interventional studies under Precursor Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 95 months of starting (the median), counting those still running; a quarter within 65 and three quarters within 109. This study's planned 127 months is above that.
Counting every sponsor, half of 59 studies reached it within 86 months; a quarter within 46 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drugs tested here: Dexamethasone · Doxorubicin · Ifosfamide · Thioguanine · Vindesine
Precursor Cell Lymphoblastic Leukemia-Lymphoma →
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