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Efficacy of Lenalidomide Maintenance in Primary Central Nervous System Lymphoma and Primary Vitreoretinal Lymphoma: a Phase II, Open-label, Single-arm Study

Primary Purpose

Primary Central Nervous System Lymphoma and Primary Vitreoretinal Lymphoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
intensity-modulated radiotherapy (IMRT)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Central Nervous System Lymphoma and Primary Vitreoretinal Lymphoma focused on measuring primary central nervous system lymphoma and primary vitreoretinal lymphoma, primary vitreoretinal lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Those who have been diagnosed with histopathological- or CSF/vitreous fluid flow cytometry- confirmedPCNSL/PVRL, DLBCL subtype and who are above 18 years of age. Those who have completed standard HD-MTX-based remission induction chemotherapy followed by reduced-dose WBRT and reached a CR or PR Patients must be able to tolerate MRI scans and lumbar punctures and/or Ommaya taps. With sufficient organ and bone marrow function, and no severe hematopoietic, heart, lung, liver, kidney, thyroid dysfunction, and immune deficiency ECOG PS 0-2 Those who can take oral medication Written informed consent under institutional guidelines. Female patients of child-bearing potential (FCBP) must have two negative pregnancy tests (sensitivity of at least 25 mIU/mL) prior to starting lenalidomide. The first pregnancy test must be performed within 10 to 14 days prior to the start of lenalidomide, and the second pregnancy test must be performed within 24 hours prior to the start of lenalidomide Effective method of contraception should be used during and for 28 days following the last dose of the drug Male patients must use an effective barrier method of contraception during study and 28 days following the last dose if sexually active with a FCBP Exclusion Criteria: Patients who are planned to undergo auto-SCT after induction chemotherapy Disease involving extra-CNSat the time of initial diagnosis Previous treatment with lenalidomide or WBRT Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within six months prior to 1st day of 1st cycle Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents Known human immunodeficiency (HIV) seropositive Those who are unable to take oral medication or unable to take antiplatelet therapy for the purpose of thromboembolism prevention. Patients with a history of malignant tumors other than the target diseases except for the following cases oIf the tumor has not been treated for at least 5 years or is disease-free oPatients at least 1 year after complete resection of basal cell carcinoma / squamous cell carcinoma or successful treatment of cervical epithelial cancer Adverse reactions within 30 days prior to screening Severe gastrointestinal bleeding exceeding Grade 2 according to the Common Terms Criteria 4.03 version criteria Occurrence of blood clots or embolism within 6 months before starting screening Patients with hypersensitivity to THIS DRUG and other ingredients of THIS DRUG (e.g., angioedema, Stevens-Jones syndrome, toxic epidermal necrosis, etc.) Female patients who are pregnant or lactating The Patient is unwell or unable to participate in all required study evaluations and procedures.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Maintenance therapy with lenalidomide as the maintenance therapy for patients with PCNSL or PVRL

    Arm Description

    Outcomes

    Primary Outcome Measures

    The incidence of tumor progression or death from all causes from the starting date of reduced-dose WBRT to the end of maintenance therapy

    Secondary Outcome Measures

    The time from the starting date of reduced-dose WBRTto death from any cause.
    The proportion of patients who achieve CR and PR.

    Full Information

    First Posted
    June 4, 2023
    Last Updated
    June 4, 2023
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05901324
    Brief Title
    Efficacy of Lenalidomide Maintenance in Primary Central Nervous System Lymphoma and Primary Vitreoretinal Lymphoma: a Phase II, Open-label, Single-arm Study
    Official Title
    Efficacy of Lenalidomide Maintenance in Primary Central Nervous System Lymphoma and Primary Vitreoretinal Lymphoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    May 31, 2031 (Anticipated)
    Study Completion Date
    May 31, 2031 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Therefore, we intend to conduct a phase II study to evaluate the efficacy of maintenance therapy with lenalidomide as the maintenance therapy for patients with PCNSL or PVRL who have achieved CR or partial response after HD-MTX-based induction therapy followed by reduced-dose WBRT.Twentypatients with PCNSL or PVRL will be recruited. The primary outcome is 2-year progression-free survival from the first date of reduced-dose WBRT. Besides, the safety and the incidence of cute and late neurotoxicity related to reduced-dose WBRT, the single nucleotide polymorphism assay,and the clinical applications of plasma and CSF circulating tumor DNA and CSF lactate level will be investigated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Central Nervous System Lymphoma and Primary Vitreoretinal Lymphoma
    Keywords
    primary central nervous system lymphoma and primary vitreoretinal lymphoma, primary vitreoretinal lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Maintenance therapy with lenalidomide as the maintenance therapy for patients with PCNSL or PVRL
    Arm Type
    Experimental
    Intervention Type
    Radiation
    Intervention Name(s)
    intensity-modulated radiotherapy (IMRT)
    Intervention Description
    1.8 Gy of 4-6 MV X-ray to a total dose of 23.4 Gy (13 fractions) will be delivered.
    Primary Outcome Measure Information:
    Title
    The incidence of tumor progression or death from all causes from the starting date of reduced-dose WBRT to the end of maintenance therapy
    Time Frame
    2-year
    Secondary Outcome Measure Information:
    Title
    The time from the starting date of reduced-dose WBRTto death from any cause.
    Time Frame
    24months
    Title
    The proportion of patients who achieve CR and PR.
    Time Frame
    24months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Those who have been diagnosed with histopathological- or CSF/vitreous fluid flow cytometry- confirmedPCNSL/PVRL, DLBCL subtype and who are above 18 years of age. Those who have completed standard HD-MTX-based remission induction chemotherapy followed by reduced-dose WBRT and reached a CR or PR Patients must be able to tolerate MRI scans and lumbar punctures and/or Ommaya taps. With sufficient organ and bone marrow function, and no severe hematopoietic, heart, lung, liver, kidney, thyroid dysfunction, and immune deficiency ECOG PS 0-2 Those who can take oral medication Written informed consent under institutional guidelines. Female patients of child-bearing potential (FCBP) must have two negative pregnancy tests (sensitivity of at least 25 mIU/mL) prior to starting lenalidomide. The first pregnancy test must be performed within 10 to 14 days prior to the start of lenalidomide, and the second pregnancy test must be performed within 24 hours prior to the start of lenalidomide Effective method of contraception should be used during and for 28 days following the last dose of the drug Male patients must use an effective barrier method of contraception during study and 28 days following the last dose if sexually active with a FCBP Exclusion Criteria: Patients who are planned to undergo auto-SCT after induction chemotherapy Disease involving extra-CNSat the time of initial diagnosis Previous treatment with lenalidomide or WBRT Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within six months prior to 1st day of 1st cycle Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents Known human immunodeficiency (HIV) seropositive Those who are unable to take oral medication or unable to take antiplatelet therapy for the purpose of thromboembolism prevention. Patients with a history of malignant tumors other than the target diseases except for the following cases oIf the tumor has not been treated for at least 5 years or is disease-free oPatients at least 1 year after complete resection of basal cell carcinoma / squamous cell carcinoma or successful treatment of cervical epithelial cancer Adverse reactions within 30 days prior to screening Severe gastrointestinal bleeding exceeding Grade 2 according to the Common Terms Criteria 4.03 version criteria Occurrence of blood clots or embolism within 6 months before starting screening Patients with hypersensitivity to THIS DRUG and other ingredients of THIS DRUG (e.g., angioedema, Stevens-Jones syndrome, toxic epidermal necrosis, etc.) Female patients who are pregnant or lactating The Patient is unwell or unable to participate in all required study evaluations and procedures.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chieh Lung Cheng, doctoral degree
    Phone
    +886972651893
    Email
    Jerome010471@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Efficacy of Lenalidomide Maintenance in Primary Central Nervous System Lymphoma and Primary Vitreoretinal Lymphoma: a Phase II, Open-label, Single-arm Study

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