CompletedPhase 2

Ibrutinib in Relapsed Nodular Lymphocyte-predominant Hodgkin Lymphoma (NLPHL)

Germany14 participantsStarted 2016-08

Plain-language summary

The purpose of this trial is to determine 1. Disease stabilization/response rate after six 21-day cycles of ibrutinib 2. Remission status after six, twelve and 20 21-day cycles of ibrutinib

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. Histologically proven relapsed nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) as confirmed by expert review
✓. Age at entry 18-99 years
✓. ECOG status 0-2
✓. Absolute leukocyte count \> 2.500/mm3
✓. Absolute neutrophil count \> 1.000/mm3 independent of growth factor support
✓. Platelet count \> 100.000/mm3 or \> 50.000/mm3 in case of bone marrow involvement independent of transfusion support in either situation
✓. GPT and GOT ≤ 3 x upper limit of normal (ULN)

Exclusion criteria

✕. Classical HL (cHL) or composite lymphoma
✕. Known central nervous lymphoma
✕. Prior Btk inhibitor treatment
✕. Life expectancy \< 3 months
✕. Major surgery within 4 weeks of study inclusion
✕. History of stroke or intracranial hemorrhage within 6 months prior to the first study drug
✕. Current anticoagulation with warfarin or equivalent vitamin K antagonists

What they're measuring

Response Rate

Timeframe: after 6 cycles (each cycle is 21 days) of Ibrutinib

Trial details

NCT IDNCT02626884

SponsorUniversity of Cologne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-08

View on ClinicalTrials.gov More Nodular Lymphocyte-Predominant Hodgkin's Lymphoma trials