Nodular Lymphocyte-Predominant Hodgkin's Lymphoma
Conditions
Brief 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
Interventions
DRUGIbrutinib
Sponsors
University of Cologne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | after 6 cycles (each cycle is 21 days) of Ibrutinib |
Secondary
| Measure | Time frame |
|---|---|
| Remission status | Remission status after six, twelve and 20 21-day cycles of ibrutinib |
Countries
Germany
Outcome results
None listed