Ibrutinib in relapsed lymphocyte-predominant Hodgkin lymphoma

Phase 1

• Conditions: relapsed lymphocyte-predominant Hodgkin lymphoma; MedDRA version: 20.0Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-003128-30-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-21
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

•Histologically proven relapsed nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
•18-99 years
•No prior Btk inhibitor Treatment

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

•Classical HL or composite lymphoma
•Concurrent disease which precludes protocol treatment
•Pregnancy, lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The Aim of the study is to establish a novel, non-toxic treatment option for patients with relapsed NLPHL.;Secondary Objective: ;Primary end point(s): - Disease stabilization/response rate after six 21-day cycles of ibrutinib ;Timepoint(s) of evaluation of this end point: The expected duration from the beginning of recruitment to the final data analysis of the primary endpoint will be about 3.5 years.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Remission status after six, twelve and 20 21-day cycles of ibrutinib <br>- Progression-free survival (PFS), 1.5-yr PFS rate<br>- Overall survival (OS), 1.5-yr OS rate<br>- Feasibility<br>- Adverse Events (incidence of severe toxicities, NCI-CTC grade III and IV)<br>- Quality of life (QoL) aspects<br>