Back to resultsEarly Systemic Central Nervous System Prophylaxis in Diffuse Large B-cell Lymphoma (BrUOG-377)
Primary Purpose
Diffuse Large B Cell Lymphoma
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Methotrexate
Cytarabine
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B Cell Lymphoma
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:
- high central nervous system International Prognostic Index,
- testicular, breast, or uterine involvement,
- dual expresser or double/triple-hit status,
- HIV positive status, or
- Molecularly defined high-risk subtype.
Exclusion Criteria:
- pregancy
- unable to provide informed consent
- significant comorbidity in the investigator's judgement
Sites / Locations
- Roxanne Wood
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CNS prophylaxis protocol
Arm Description
Patients will receive central nervous system prophylaxis protocol using high-dose methotrexate and cytarabine.
Outcomes
Primary Outcome Measures
Proportion with clinically significant toxicity
Clinically significant toxicity as defined in the protocol
Secondary Outcome Measures
Cumulative incidence of central nervous system recurrence
Cumulative incidence of central nervous system recurrence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03719560
Brief Title
Early Systemic Central Nervous System Prophylaxis in Diffuse Large B-cell Lymphoma
Acronym
BrUOG-377
Official Title
Early Systemic Central Nervous System Prophylaxis in Diffuse Large B-cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Withdrawn
Why Stopped
lack of funding
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell 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
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CNS prophylaxis protocol
Arm Type
Experimental
Arm Description
Patients will receive central nervous system prophylaxis protocol using high-dose methotrexate and cytarabine.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
Methotrexate sodium
Intervention Description
Systemic methotrexate
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Other Intervention Name(s)
Cytosar-U
Intervention Description
Systemic cytarabine
Primary Outcome Measure Information:
Title
Proportion with clinically significant toxicity
Description
Clinically significant toxicity as defined in the protocol
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Cumulative incidence of central nervous system recurrence
Description
Cumulative incidence of central nervous system recurrence
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
high central nervous system International Prognostic Index,
testicular, breast, or uterine involvement,
dual expresser or double/triple-hit status,
HIV positive status, or
Molecularly defined high-risk subtype.
Exclusion Criteria:
pregancy
unable to provide informed consent
significant comorbidity in the investigator's judgement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam J Olszewski, MD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roxanne Wood
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Early Systemic Central Nervous System Prophylaxis in Diffuse Large B-cell Lymphoma
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