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

Primary Purpose

Nodular Lymphocyte-Predominant Hodgkin's Lymphoma

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Ibrutinib
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nodular Lymphocyte-Predominant Hodgkin's Lymphoma

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1st Department of Medicine, Cologne University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ibrutinib

Arm Description

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

Outcomes

Primary Outcome Measures

Response Rate

Secondary Outcome Measures

Remission status

Full Information

First Posted
December 2, 2015
Last Updated
April 6, 2021
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT02626884
Brief Title
Ibrutinib in Relapsed Nodular Lymphocyte-predominant Hodgkin Lymphoma (NLPHL)
Acronym
IRENO
Official Title
Ibrutinib in Relapsed Nodular Lymphocyte-predominant Hodgkin Lymphoma (NLPHL)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2020 (Actual)
Study Completion Date
August 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this trial is to determine Disease stabilization/response rate after six 21-day cycles of ibrutinib Remission status after six, twelve and 20 21-day cycles of ibrutinib

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nodular Lymphocyte-Predominant Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibrutinib
Arm Type
Experimental
Arm Description
All patient receive ibrutinib at a dose of 560 mg/d for up to 20 21-day cycles
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Primary Outcome Measure Information:
Title
Response Rate
Time Frame
after 6 cycles (each cycle is 21 days) of Ibrutinib
Secondary Outcome Measure Information:
Title
Remission status
Time Frame
Remission status after six, twelve and 20 21-day cycles of ibrutinib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Engert, Prof.
Organizational Affiliation
University Hospital of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st Department of Medicine, Cologne University Hospital
City
Cologne
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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