Phase II study of fixed‐duration single‐agent ibrutinib in relapsed nodular lymphocyte‐predominant Hodgkin lymphoma: A report from the German Hodgkin Study Group

Abstract

Nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) is a rare lymphoma entity accounting for approximately 5% of all Hodgkin lymphoma (HL) cases. Patients with NLPHL have an excellent long-term survival although disease recurrence is more common than in classical HL. 1 No standard of care for relapsed NLPHL is defined until now. 2 Single-agent anti-CD20 antibody treatment, radiotherapy (RT) alone or conventional chemotherapy optionally combined with an anti-CD20 antibody and/or RT are mostly sufficient. 3,4 High-dose chemotherapy and autologous stem cell transplantation (ASCT) is only considered in poor-risk patients. 5 Due to the increased relapse rate on one hand and the very good long-term prognosis on the other hand, novel approaches with an optimized balance between efficacy and toxicity are needed for NLPHL patients. Given the frequent expression of the Bruton tyrosine kinase (Btk) in this disease, a phase II study investigating the Btk inhibitor ibrutinib in individuals with relapsed NLPHL was initiated. 6 The study was conducted at 3 sites in Germany. Patients with biopsy-proven NLPHL recurrence aged ≥18 years were eligible. All patients initially received 6 cycles (duration of each cycle: 21 days) of study treatment consisting of single-agent ibrutinib at 560 mg/ d before positron emission tomography (PET) and computed tomography (CT) (PET/CT) were conducted. In case the PET/CT revealed at least stable disease (SD), 6 additional cycles were given.At the end of the 6 additional cycles, patients underwent CT-based staging. Patients with a partial remission (PR) or a complete remission (CR) had another 8 cycles for a total of 20 cycles whereas patients with ongoing SD or progressive disease (PD) did not continue treatment. After the final re-staging, patients had follow-up examinations every 3 months within the first year and every 6 months thereafter. The study was approved by the review boards of the

Treatment of Nodular Lymphocyte-Predominant Hodgkin Lymphoma: Where Do We Stand? Where Do We Go?

“…At a median follow-up of 25 months, the 18-month PFS rate was 56.3%. Thus, disease control with this approach was worse than with single-agent anti-CD20 antibody treatment [ 42 ].…”

Individualized patient care in nodular lymphocyte-predominant Hodgkin lymphoma

“…A recent study has eval u ated ibru tinib in relapsed NLPHL, but 18month PFS was dis ap point ing at 56%. 29 Options for relapsed NLPHL are sum ma rized in Table 3.…”