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

• Status: Completed
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cologne

Criteria

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