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OpenTrials
Completed

NCT Number: NCT02626884

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

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

Completed

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Key information

Conditions

Nodular Lymphocyte-Predominant Hodgkin's Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1st Department of Medicine, Cologne University Hospital

Cologne, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(key criteria):

  • Histologically proven relapsed nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) as confirmed by expert review
  • Age at entry 18-99 years
  • ECOG status 0-2
  • Absolute leukocyte count > 2.500/mm3
  • Absolute neutrophil count > 1.000/mm3 independent of growth factor support
  • Platelet count > 100.000/mm3 or > 50.000/mm3 in case of bone marrow involvement independent of transfusion support in either situation
  • GPT and GOT ≤ 3 x upper limit of normal (ULN)

Exclusion criteria

(key criteria):

  • Classical HL (cHL) or composite lymphoma
  • Known central nervous lymphoma
  • Prior Btk inhibitor treatment
  • Life expectancy < 3 months
  • Major surgery within 4 weeks of study inclusion
  • History of stroke or intracranial hemorrhage within 6 months prior to the first study drug
  • Current anticoagulation with warfarin or equivalent vitamin K antagonists

Treatment and study plan

Ibrutinib

Drug

Primary outcomes

  1. Response Rate

    Time frame: after 6 cycles (each cycle is 21 days) of Ibrutinib

Secondary outcomes

  1. Remission status

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

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Acronym: IRENO

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 10, 2015
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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