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

  • STATUS
    Recruiting
  • End date
    Dec 29, 2022
  • participants needed
    30
  • sponsor
    Rabin Medical Center
Updated on 29 March 2021
renal function
methotrexate
rituximab
growth factor
maintenance treatment
neutrophil count
diffuse large b-cell lymphoma
ibrutinib
imbruvica

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

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

Details
Condition Primary Central Nervous System Lymphoma, Central Nervous System Lymphoma, Primary CNS Lymphoma, cns lymphoma
Treatment Imbruvica
Clinical Study IdentifierNCT02623010
SponsorRabin Medical Center
Last Modified on29 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 60 yrs and 85 yrs?
Gender: Male or Female
Do you have Central Nervous System Lymphoma?
Do you have any of these conditions: Central Nervous System Lymphoma or cns lymphoma or Primary CNS Lymphoma or Primary Central Nervous System Lymphoma?
Do you have any of these conditions: Primary CNS Lymphoma or Primary Central Nervous System Lymphoma or cns lymphoma or Central Nervous System Lymphoma?
Do you have any of these conditions: cns lymphoma or Primary CNS Lymphoma or Primary Central Nervous System Lymphoma or Central Nervous System Lymphoma?
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/l independent of growth factor support
Platelets 100,000/l or 50,000/l 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
\-

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
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