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

NCT02623010 | Unknown Phase 2

• 1 other identifier: 0356-15-RMC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Central Nervous System Lymphoma

Keywords

Primary CNS lymphoma; Ibrutinib; Elderly; Maintenance

Outcome Measures

Primary Outcomes (1)

• PFS- progression free survival

  Progression free survival

  3 years

Secondary Outcomes (1)

• Overall survival

  4 years

Study Arms (1)

Single arm

EXPERIMENTAL

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

Interventions

Imbruvica DRUG

Bruton's Tyrosine Kinase Inhibitor Ibrutinib as maintenance treatment in elderly patients with primary CNS lymphoma following first line chemotherapy treatment

Also known as: Ibrutinib, JNJ-54179060

Single arm

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead
• Janssen, LP: collaborator

Study Sites (1)

Hematology Institute

Petah Tikva, 494192, Israel

RECRUITING

Related Publications (1)

• Bairey O, Taliansky A, Glik A, Amiel A, Yust-Katz S, Gurion R, Zektser M, Porges T, Sarid N, Horowitz NA, Shina TT, Lebel E, Cohen A, Geiger KR, Raanani P, Wolach O, Siegal T. A phase 2 study of ibrutinib maintenance following first-line high-dose methotrexate-based chemotherapy for elderly patients with primary central nervous system lymphoma. Cancer. 2023 Dec 15;129(24):3905-3914. doi: 10.1002/cncr.34985. Epub 2023 Aug 12.

  PMID: 37572086 DERIVED

MeSH Terms

Interventions

ibrutinib

Study Officials

• Osnat Bairey, MD

  Senior Hematologist, Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Osnat Bairey, MD

CONTACT

972504065471; osnatb@clalit.org.il

Tali Siegal, MD

CONTACT

97239377950; talisi1@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: December 7, 2015
• Study Start: October 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 10, 2022

Record last verified: 2022-05

Locations

IL (1)