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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03719560
Recruitment Status : Withdrawn (lack of funding)
First Posted : October 25, 2018
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
Brown University

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
Diffuse Large B Cell Lymphoma Drug: Methotrexate Drug: Cytarabine 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.

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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2025


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 Name: Methotrexate sodium

Drug: Cytarabine
Systemic cytarabine
Other Name: Cytosar-U




Primary Outcome Measures :
  1. Proportion with clinically significant toxicity [ Time Frame: 1 year ]
    Clinically significant toxicity as defined in the protocol


Secondary Outcome Measures :
  1. Cumulative incidence of central nervous system recurrence [ Time Frame: 2 years ]
    Cumulative incidence of central nervous system recurrence



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719560


Locations
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United States, Rhode Island
Roxanne Wood
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Brown University
Investigators
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Principal Investigator: Adam J Olszewski, MD Rhode Island Hospital
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Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT03719560    
Other Study ID Numbers: BrUOG-377
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020

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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:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cytarabine
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antiviral Agents
Anti-Infective Agents