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

Nodular Lymphocyte-Predominant Hodgkin's Lymphoma Clinical Trial

— IRENO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02626884
• Other study ID #: Uni-Koeln-1776
• Secondary ID: 2015-003128-30
• Status: Completed
• Phase: Phase 2
• Start date: August 2016
• Est. completion date: August 2020

Study information

• Verified date: April 2021
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Nodular Lymphocyte-Predominant Hodgkin's Lymphoma

Intervention

Drug:
• Ibrutinib

Locations

Country	Name	City	State
Germany	1st Department of Medicine, Cologne University Hospital	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate		after 6 cycles (each cycle is 21 days) of Ibrutinib
Secondary	Remission status		Remission status after six, twelve and 20 21-day cycles of ibrutinib