International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
Recruiting
Phase 3
Interventional Study
Lymphoblastic Lymphoma, Childhood
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- Up to 18
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 683 (estimated)
- Sponsor
- University Hospital Muenster · Other
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About This Trial
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…
Trial Locations
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Eligibility 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
* will…
Contacts