Clinical trial · Interventional
Ibrutinib in Relapsed Nodular Lymphocyte-predominant Hodgkin Lymphoma (NLPHL)
NCT02626884CI-TRIAL-00051162IRENOcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nodular Lymphocyte-Predominant Hodgkin's Lymphoma | Nodular Lymphocyte Predominant B-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibrutinib | Drug | Ibrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ibrutinib
- description
- All patient receive ibrutinib at a dose of 560 mg/d for up to 20 21-day cycles
- interventionNames
- Drug: Ibrutinib
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- after 6 cycles (each cycle is 21 days) of Ibrutinib
Secondary outcomes (1)
- measure
- Remission status
- timeFrame
- Remission status after six, twelve and 20 21-day cycles of ibrutinib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria (key criteria): 1. Histologically proven relapsed nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) as confirmed by expert review 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 (key criteria): 1. Classical HL (cHL) or composite lymphoma 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
References
Publications (0)
Data not yet available
No reference posted for this study.