Back to resultsIntrathecal Rituximab With Standard Intrathecal Prophylaxis to Prevent CNS Relapse for CD 20+ Non Hodgkin Lymphoma
Primary Purpose
Non Hodgkin Lymphoma
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Non Hodgkin Lymphoma
Eligibility Criteria
Inclusion Criteria:
- CD20 positive diffuse large b-cell lymphoma undergoing treatment with systemic rituximab in combination with CHOP, CHOEP, or EPOCH and deemed high risk of CNS relapse and eligible for central nervous system prophylaxis with intrathecal therapy.
Exclusion Criteria:
- Primary central nervous system lymphoma or established secondary central nervous system disease.
- History of spinal surgery and/or ineligible for intrathecal injections.
Sites / Locations
- UC Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intrathecal rituximab
Arm Description
Cohort 1: 10 mg dose, day 1 chemotherapy cycles 2-5 Cohort 2: 20 mg dose, day 1 chemotherapy cycles 2-5
Outcomes
Primary Outcome Measures
Ability to deliver greater than 80% of planned doses
Percentage of planned doses administered for planned accrual
Related Grade 3 or higher non-hematological toxicity
Number of related grade 3 or higher non-hematological toxicities
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03688451
Brief Title
Intrathecal Rituximab With Standard Intrathecal Prophylaxis to Prevent CNS Relapse for CD 20+ Non Hodgkin Lymphoma
Official Title
A Pilot Study to Access the Feasibility and Safety of Intrathecal Rituximab Added to Standard Intrathecal Prophylaxis to Prevent CNS Relapse for CD 20 Positive Non Hodgkin Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tahir Latif
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
The purpose of this research study is to learn if giving rituximab, the study drug, right into the spinal canal along with chemotherapy drugs like methotrexate is possible and safe.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Hodgkin Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Sequential dose cohorts
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intrathecal rituximab
Arm Type
Experimental
Arm Description
Cohort 1: 10 mg dose, day 1 chemotherapy cycles 2-5 Cohort 2: 20 mg dose, day 1 chemotherapy cycles 2-5
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Intrathecal administration over 3-5 minutes
Primary Outcome Measure Information:
Title
Ability to deliver greater than 80% of planned doses
Description
Percentage of planned doses administered for planned accrual
Time Frame
28 months
Title
Related Grade 3 or higher non-hematological toxicity
Description
Number of related grade 3 or higher non-hematological toxicities
Time Frame
28 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CD20 positive diffuse large b-cell lymphoma undergoing treatment with systemic rituximab in combination with CHOP, CHOEP, or EPOCH and deemed high risk of CNS relapse and eligible for central nervous system prophylaxis with intrathecal therapy.
Exclusion Criteria:
Primary central nervous system lymphoma or established secondary central nervous system disease.
History of spinal surgery and/or ineligible for intrathecal injections.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tahir Latif, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intrathecal Rituximab With Standard Intrathecal Prophylaxis to Prevent CNS Relapse for CD 20+ Non Hodgkin Lymphoma
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