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

Phase 2

Completed

• Conditions: Nodular Lymphocyte-Predominant Hodgkin's Lymphoma
• Interventions: Drug: Ibrutinib

• Registration Number: NCT02626884
• Lead Sponsor: University of Cologne

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-10
• Study Start: 2016-08
• Primary Completion: 2020-08
• Study Completion: 2020-08
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ibrutinib	Ibrutinib	All patient receive ibrutinib at a dose of 560 mg/d for up to 20 21-day cycles

Primary Outcome Measures

Name	Time	Method
Response Rate	after 6 cycles (each cycle is 21 days) of Ibrutinib

Secondary Outcome Measures

Name	Time	Method
Remission status	Remission status after six, twelve and 20 21-day cycles of ibrutinib

Trial Locations

Locations (1)

1st Department of Medicine, Cologne University Hospital; 🇩🇪 Cologne, Germany