Clinical Trials /

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

NCT03719560

Description:

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

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Double-Hit Lymphoma
  • Triple-Hit Lymphoma
Recruiting Status:

Withdrawn

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Early Systemic Central Nervous System Prophylaxis in Diffuse Large B-cell Lymphoma
  • Official Title: Early Systemic Central Nervous System Prophylaxis in Diffuse Large B-cell Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: BrUOG-377
  • NCT ID: NCT03719560

Conditions

  • Diffuse Large B Cell Lymphoma

Interventions

DrugSynonymsArms
MethotrexateMethotrexate sodiumCNS prophylaxis protocol
CytarabineCytosar-UCNS prophylaxis protocol

Purpose

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

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.
    

Trial Arms

NameTypeDescriptionInterventions
CNS prophylaxis protocolExperimentalPatients will receive central nervous system prophylaxis protocol using high-dose methotrexate and cytarabine.
  • Methotrexate
  • Cytarabine

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Proportion with clinically significant toxicity
Time Frame:1 year
Safety Issue:
Description:Clinically significant toxicity as defined in the protocol

Secondary Outcome Measures

Measure:Cumulative incidence of central nervous system recurrence
Time Frame:2 years
Safety Issue:
Description:Cumulative incidence of central nervous system recurrence

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Brown University

Last Updated

April 7, 2019