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

University of Cologne

Status and phase: Completed; Phase 2

Conditions: Nodular Lymphocyte-Predominant Hodgkin's Lymphoma

Treatments: Drug: Ibrutinib

Study type: Interventional

Funder types: Other

Identifiers

NCT02626884

2015-003128-30 (EudraCT Number)

Uni-Koeln-1776

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Ibrutinib

Experimental group

Description:

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

Treatment:

Drug: Ibrutinib