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BrUOG-377: Early Systemic Central Nervous System Prophylaxis in Diffuse Large B-cell Lymphoma

Sponsor
Brown University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03719560
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
78
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Phase 2 single-institution trial of early systemic central nervous system prophylaxis in high-risk diffuse large B-cell lymphoma

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This is a prospective phase 2 clinical trial of systemic central nervous system prophylaxis among patients with diffuse large B-cell lymphoma at high risk of central nervous system recurrence. The main objective is to evaluate safety and efficacy of early institution of intensive central nervous system prophylaxis in a high-risk group to minimize the risk of a devastating central nervous system recurrence. Patients receive standard primary immunochemotherapy with an addition of planned central nervous system prophylaxis courses on or around day 15 of cycles 2, 4, and 6. Growth factor support and Pneumocystis jirovecii prophylaxis is required. The primary endpoint of this pilot study is protocol-defined toxicity, whereas efficacy (cumulative incidence of central nervous system recurrence) will be a secondary endpoint.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Early Systemic Central Nervous System Prophylaxis in Diffuse Large B-cell Lymphoma
Anticipated Study Start Date :
Jul 1, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: CNS prophylaxis protocol

Patients will receive central nervous system prophylaxis protocol using high-dose methotrexate and cytarabine.

Drug: Methotrexate
Systemic methotrexate
Other Names:
  • Methotrexate sodium

    • Drug: Cytarabine
    Systemic cytarabine
    Other Names:
  • Cytosar-U

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion with clinically significant toxicity [1 year]

      Clinically significant toxicity as defined in the protocol

    Secondary Outcome Measures

    1. Cumulative incidence of central nervous system recurrence [2 years]

      Cumulative incidence of central nervous system recurrence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • New diagnosis of diffuse large B-cell lymphoma, planned first-line therapy using the standard rituximab- and anthracycline-containing regimens

    • No central nervous system involvement on initial staging

    • Performance status of 0 or 1 (Eastern Cooperative Oncology Group scale)

    • Renal function: creatinine clearance >45 ml/min

    • Not pregnant; agreeable to contraception

    • Written informed consent

    • High risk for central nervous system recurrence as determined by one of the following high-risk features:

    1. high central nervous system International Prognostic Index,

    2. testicular, breast, or uterine involvement,

    3. dual expresser or double/triple-hit status,

    4. HIV positive status, or

    5. Molecularly defined high-risk subtype.

    Exclusion Criteria:

    • pregancy

    • unable to provide informed consent

    • significant comorbidity in the investigator's judgement

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Roxanne Wood Providence Rhode Island United States 02903

    Sponsors and Collaborators

    • Brown University

    Investigators

    • Principal Investigator: Adam J Olszewski, MD, Rhode Island Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brown University
    ClinicalTrials.gov Identifier:
    NCT03719560
    Other Study ID Numbers:
    • BrUOG-377
    First Posted:
    Oct 25, 2018
    Last Update Posted:
    Apr 13, 2020
    Last Verified:
    Apr 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, B-Cell
    Lymphoma, Large B-Cell, Diffuse
    Cytarabine
    Methotrexate

    Study Results

    No Results Posted as of Apr 13, 2020