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Trial record 89 of 318 for:    ibrutinib

Bruton's Tyrosine Kinase Inhibitor Ibrutinib as Maintenance Treatment in Elderly Patients With Primary CNS Lymphoma

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ClinicalTrials.gov Identifier: NCT02623010
Recruitment Status : Recruiting
First Posted : December 7, 2015
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Osnat Bairey, Rabin Medical Center

Brief Summary:

The study will include 30 elderly patients age 60-85 with primary CNS DLBCL . Induction treatment will include Rituximab and high dose methotrexate protocol (containing at least methotrexate and one more chemotherapy agent).

Patients with MRI documented response CR or PR will enter the study protocol maintenance phase which will include continous treatment with Ibrutinib 560 mg day until relapse or disease progression or occurrence of limiting toxicities


Condition or disease Intervention/treatment Phase
Central Nervous System Lymphoma Drug: Imbruvica Phase 2

Detailed Description:

30 elderly patients age 60-85 with primary CNS DLBCL who will achieve response CR or PR will enter the study protocol maintenance phase.

Induction treatment will include Rituximab and high dose methotrexate protocol (containing at least methotrexate and one more chemotherapy agent).

Patients with MRI documented response CR or PR will enter the study protocol maintenance phase.

Maintenance: 28 day cycles of Ibrutinib 560 mg orally once daily until relapse or disease progression or occurrence of limiting toxicities

Evaluation of response:

Radiologic evaluation by MRI will be performed every 3 months. Neurologic status evaluation every 2 months Neurocognitive evaluation every 6 months


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib as Maintenance Treatment in Elderly Patients With Primary CNS Lymphoma Following First Line Chemotherapy Treatment
Actual Study Start Date : October 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: Single arm
Imbruvica (ibrutinib) will be given as maintenance treatment until relapse or toxicity to 30 elderly PCNSL patients after achieving response to first line treatment
Drug: Imbruvica
Bruton's Tyrosine Kinase Inhibitor Ibrutinib as maintenance treatment in elderly patients with primary CNS lymphoma following first line chemotherapy treatment
Other Names:
  • Ibrutinib
  • JNJ-54179060




Primary Outcome Measures :
  1. PFS- progression free survival [ Time Frame: 3 years ]
    Progression free survival


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 4 years ]
    Overall survival



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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed PCNSL patients whose age is >60 years and achieved response (CR/PR) after first line immunochemotherapy treatment
  • Tissue diagnosis is mandatory unless positive cerebrospinal fluid (CSF) cytology or vitrectomy are diagnostic with no evidence for systemic disease
  • No contraindication for high dose methotrexate (HD-MTX) (adequate renal function)
  • KPS > 40%, ECOG < 3
  • Hematology values must be within the following limits:

Absolute neutrophil count (ANC) ≥ 1000/µl independent of growth factor support Platelets ≥100,000/µl or ≥50,000/µl if bone marrow involvement independent of transfusion support in either situation • Biochemical values within the following limits: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) Total bilirubin ≤ 1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin Serum creatinine ≤ 2 x ULN or estimated Glomerular Filtration Rate (Cockroft Gault≥ 40 mL/min

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Exclusion Criteria:

  • Major surgery within 4 weeks of randomization.
  • History of stroke or intracranial hemorrhage within 6 months prior to randomization.
  • Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon).
  • Requires treatment with strong CYP3A inhibitors.
  • Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.
  • Vaccinated with live, attenuated vaccines within 4 weeks of randomization.
  • Known history of human immunodeficiency virus (HIV) or active Hepatitis C Virus or active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (IV) 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 capsules, or put the study outcomes at undue risk.

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): NCT02623010


Contacts
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Contact: Osnat Bairey, MD 972504065471 osnatb@clalit.org.il
Contact: Tali Siegal, MD 97239377950 talisi1@clalit.org.il

Locations
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Israel
Hematology Institute Recruiting
Petah Tikva, Israel, 494192
Contact: Osnat Bairey, MD    972504065471    osnatb@clalit.org.il   
Contact: Tali Siegal, MD    97239377950    talisi1@clalit.org.il   
Sponsors and Collaborators
Rabin Medical Center
Janssen, LP
Investigators
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Principal Investigator: Osnat Bairey, MD Senior Hematologist, Rabin Medical Center

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Responsible Party: Osnat Bairey, MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02623010     History of Changes
Other Study ID Numbers: 0356-15-RMC
First Posted: December 7, 2015    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Keywords provided by Osnat Bairey, Rabin Medical Center:
Primary CNS lymphoma
Ibrutinib
Elderly
Maintenance
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases