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

April 6, 2021 updated by: Prof. Dr. Andreas Engert, University of Cologne

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany
        • 1st Department of Medicine, Cologne University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ibrutinib
All patient receive ibrutinib at a dose of 560 mg/d for up to 20 21-day cycles
Drug: Ibrutinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response Rate
Time Frame: after 6 cycles (each cycle is 21 days) of Ibrutinib
after 6 cycles (each cycle is 21 days) of Ibrutinib

Secondary Outcome Measures

Outcome Measure
Time Frame
Remission status
Time Frame: Remission status after six, twelve and 20 21-day cycles of ibrutinib
Remission status after six, twelve and 20 21-day cycles of ibrutinib

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Investigators

  • Principal Investigator: Andreas Engert, Prof., University Hospital of Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

December 2, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (Estimate)

December 10, 2015

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uni-Koeln-1776
  • 2015-003128-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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