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International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

Study acronym: LBL 2018
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary and study completion dates: Nov 22, 2027 to Apr 22, 2030v10
  2. Study sites: 223 to 228v9
  3. Site details revised at 26 of 223 sitesv8
  4. Re-verified, no change to tracked fieldsv7
  5. Primary and study completion dates: Oct 31, 2027 to Nov 22, 2027
    • Study sites revised (223)
    • Study description shortened, about 2 words
    v6
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  1. Site details revised at 30 of 223 sitesv5
  2. Study sites: 222 to 223v4
  3. Study sites: 221 to 222v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2019 to Aug 23, 2019
    • Site details revised at 221 of 221 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT04043494
Lead Sponsor University Hospital Muenster
Collaborators: Deutsche Krebshilfe e.V., Bonn (Germany)
Conditions
(from sponsor)		 Lymphoblastic Lymphoma, Childhood
Related terms Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 683 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov