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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02626884
Recruitment Status : Completed
First Posted : December 10, 2015
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Andreas Engert, University of Cologne

Study Description
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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

Condition or disease Intervention/treatment Phase
Nodular Lymphocyte-Predominant Hodgkin's Lymphoma Drug: Ibrutinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ibrutinib in Relapsed Nodular Lymphocyte-predominant Hodgkin Lymphoma (NLPHL)
Study Start Date : August 2016
Actual Primary Completion Date : August 2020
Actual Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ibrutinib

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Response Rate [ Time Frame: after 6 cycles (each cycle is 21 days) of Ibrutinib ]

Secondary Outcome Measures :
  1. Remission status [ Time Frame: Remission status after six, twelve and 20 21-day cycles of ibrutinib ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02626884


Locations
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Germany
1st Department of Medicine, Cologne University Hospital
Cologne, Germany
Sponsors and Collaborators
University of Cologne
Investigators
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Principal Investigator: Andreas Engert, Prof. University Hospital of Cologne
More Information
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Responsible Party: Prof. Dr. Andreas Engert, Prof., University of Cologne
ClinicalTrials.gov Identifier: NCT02626884    
Other Study ID Numbers: Uni-Koeln-1776
2015-003128-30 ( EudraCT Number )
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases