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New treatment option for Lymphoblastic Lymphoma, Childhood
Official title International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
ClinicalTrials.gov ID: NCT04043494
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an once-weekly, being studied as a potential treatment for lymphoblastic lymphoma, childhood.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 18
You may be able to join if
- 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...
- willingness of patients and the investigator/pathologist to provide adequate slides/blocks for reference (molecular) pathology and international...
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Graz, Austria
- Innsbruck, Austria
- Linz, Austria
- Salzburg, Austria
- Vienna, Austria
- Brussels, Belgium
- Edegem, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Liège, Belgium
- Montegnée, Belgium
- Hong Kong, China
- Brno, Czechia
- Prague, Czechia
- Aalborg, Denmark
- Aarhus, Denmark
- Copenhagen, Denmark
- Odense, Denmark
- Helsinki, Finland
- Kuopio, Finland
+ 192 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Graz, Austria; Innsbruck, Austria; Linz, Austria; Salzburg, Austria; Vienna, Austria; Brussels, Belgium and 206 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.