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

• Sponsor: Rabin Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02623010
• Collaborator: Janssen, LP (Industry)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 86
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• 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: Oct 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. PFS- progression free survival [3 years]

   Progression free survival

Secondary Outcome Measures

1. Overall survival [4 years]

   Overall survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

-

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hematology Institute	Petah Tikva		Israel	494192

Sponsors and Collaborators

• Rabin Medical Center
• Janssen, LP

Investigators

• Principal Investigator: Osnat Bairey, MD, Senior Hematologist, Rabin Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Osnat Bairey, MD, Rabin Medical Center
• ClinicalTrials.gov Identifier: NCT02623010
• Other Study ID Numbers: 0356-15-RMC
• First Posted: Dec 7, 2015
• Last Update Posted: May 10, 2022
• Last Verified: May 1, 2022

• Keywords provided by Osnat Bairey, MD, Rabin Medical Center: Primary CNS lymphoma; Ibrutinib; Elderly; Maintenance
• Additional relevant MeSH terms: Lymphoma

Study Results

No Results Posted as of May 10, 2022