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IRENO

AcronymISRCTNEudraCTClinicaltrials.govDRKS
Uni-Koeln-17762015-003128-30NCT02626884

Ibrutinib in relapsed nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL)

Status: Active (Recruitment Closed)

Purpose / Objectives

Primary Outcome

  • Disease stabilization/response rate after six 21-day cycles of Ibrutinib

Secondary Outcomes

  • Remission status after six, twelve and 20 21-day cycles of Ibrutinib
  • Progression-free survival (PFS)
  • Overall survival (OS)
  • Feasibility
  • Adverse Events (incidence of severe toxicities, NCI-CTC grade III and IV)
  • Quality of life (QoL) aspects

Diagnosis

Patient attributes

Stage

relapsed

Age

18-99

Inclusion criteria

  • Histologically proven relapsed nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) as confirmed by expert review
  • Age at entry 18-99 years
  • WHO status 0-2
  • Absolute leukocyte count > 2.500/mm3
  • Absolute neutrophil count > 1.000/mm3
  • Platelet count > 100.000/mm3 or > 50.000/mm3 in case of bone marrow involvement
  • Bilirubin < 2 mg/dl, GOT and GPT ≤ 3 x upper limit of normal
  • Serum creatinine ≤ 2 x upper limit of normal or glomerular filtration rate ≥ 40 ml/min/1.73 m2
  • Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug.
  • Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [b-hCG]) or urine pregnancy test at screening. Women who are pregnant or breastfeeding are ineligible for this study.
  • Patient has given his/her written informed consent to participate in the trial
  • Normal organ function
  • Negative HIV test
  • [...]

Exclusion criteria

  • Classical HL (cHL) or composite lymphoma
  • Known central nervous lymphoma
  • Prior Btk inhibitor treatment
  • Major surgery within 4 weeks of study inclusion
  • History of stroke or intracranial hemorrhage within 6 months of study inclusion
  • Current anticoagulation with warfarin or equivalent vitamin K antagonists
  • Treatment with strong CYPA3 inhibitors
  • Vaccination with live, attenuated vaccines within 4 weeks of study inclusion
  • Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within six months of study inclusion, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
  • Known history of immunodeficiency virus (HIV), active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection or any uncontrolled systemic infection requiring intravenous antibiotics
  • Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator´s opinion, could compromise the subject´s safety, interfere with the absorption or metabolism of Ibrutinib, or put the study outcomes at undue risk
  • Poorly controlled diabetes mellitus (Hba1c > 7.5%)
  • Elevated fasting blood sugar > 200 mg/dl
  • Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated cervical in situ carcinoma are eligible
  • Glucocorticoid use, unless given in doses ≤ 100 mg daily hydrocortisone (or equivalent dose of other glucocorticoid) for < 7 days for exacerbations other than NLPHL (e.g. asthma)
  • Pregnancy, lactation
  • [...]

Trial design

  • Phase II
  • Multicenter
  • Prospective
  • One-arm
  • Open Label

Intervention

Up to 20 21-day cycles of the oral Bruton tyrosine kinase (Btk) inhibitor Ibrutinib at a dose of 560 mg/d

Documents (password protected)

Responsibilities in overall trial

Universität zu Köln

  • Tel. +49 (0)221 478 0

National Coordinating Investigator

Univ.-Prof. Dr. med. Andreas Engert

Study Sites

Klinik I für Innere Medizin

Study office

  • Klinisches Studienzentrum der Klinik I für Innere Medizin Köln

Status

Active (Recruitment Closed)

Principal Investigator

Univ.-Prof. Dr. med. Andreas Engert

Deputy of Principal Investigator

  • Dr. med. Dennis Eichenauer

Subinvestigator

  • Dr. med. Sascha Ansén
  • PD Dr. med. Boris Böll
  • Sven Borchmann
  • Dr. med. Paul Bröckelmann
  • Dr. Stefanie Kreissl
  • Prof. Dr. med. Christian Pallasch
  • Dr. med. Armin Tuchscherer
  • PD Dr. med. Thomas Zander
  • Dr. med. Janine Böll, geb. Schwamb
  • Dr. med. Anja Jühling
  • Johanna Prinz

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