Ibrutinib in Relapsed Nodular Lymphocyte-predominant Hodgkin Lymphoma (NLPHL)
NCT ID: NCT02626884
Last Updated: 2021-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
14 participants
INTERVENTIONAL
2016-08-31
2020-08-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ibrutinib
All patient receive ibrutinib at a dose of 560 mg/d for up to 20 21-day cycles
Ibrutinib
Interventions
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Ibrutinib
Eligibility Criteria
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Inclusion Criteria
2. Age at entry 18-99 years
3. ECOG status 0-2
4. Absolute leukocyte count \> 2.500/mm3
5. Absolute neutrophil count \> 1.000/mm3 independent of growth factor support
6. Platelet count \> 100.000/mm3 or \> 50.000/mm3 in case of bone marrow involvement independent of transfusion support in either situation
7. GPT and GOT ≤ 3 x upper limit of normal (ULN)
Exclusion Criteria
2. Known central nervous lymphoma
3. Prior Btk inhibitor treatment
4. Life expectancy \< 3 months
5. Major surgery within 4 weeks of study inclusion
6. History of stroke or intracranial hemorrhage within 6 months prior to the first study drug
7. Current anticoagulation with warfarin or equivalent vitamin K antagonists
18 Years
99 Years
ALL
No
Sponsors
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University of Cologne
OTHER
Responsible Party
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Prof. Dr. Andreas Engert
Prof.
Principal Investigators
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Andreas Engert, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Cologne
Locations
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1st Department of Medicine, Cologne University Hospital
Cologne, , Germany
Countries
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Other Identifiers
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Uni-Koeln-1776
Identifier Type: -
Identifier Source: org_study_id
2015-003128-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
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