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Monoclonal Antibodies

Rituximab for Non-Hodgkin Lymphoma

Phase 2
Waitlist Available
Led By Tahir Latif, MD
Research Sponsored by Tahir Latif
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 months
Awards & highlights

Study Summary

This trial is testing if it's safe to give rituximab, a cancer drug, into the spinal canal along with other chemo drugs.

Who is the study for?
This trial is for people with a type of Non-Hodgkin's Lymphoma that has a high risk of spreading to the brain and spinal cord. Participants must be undergoing treatment with rituximab combined with certain chemotherapy regimens (CHOP, CHOEP, or EPOCH) and qualify for preventive therapy in the central nervous system.Check my eligibility
What is being tested?
The study is testing if injecting rituximab directly into the spinal canal, along with standard chemotherapy drugs like methotrexate, is both doable and safe for patients at high risk of their lymphoma affecting the central nervous system.See study design
What are the potential side effects?
Potential side effects may include complications related to intrathecal injections such as infection or injury at injection site, possible reactions to rituximab like fever or chills, and typical chemotherapy-related issues such as nausea or low blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a high-risk B-cell lymphoma and am getting rituximab with CHOP, CHOEP, or EPOCH.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ability to deliver greater than 80% of planned doses
Related Grade 3 or higher non-hematological toxicity

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038
4%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intrathecal rituximabExperimental Treatment1 Intervention
Cohort 1: 10 mg dose, day 1 chemotherapy cycles 2-5 Cohort 2: 20 mg dose, day 1 chemotherapy cycles 2-5
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved

Find a Location

Who is running the clinical trial?

Tahir LatifLead Sponsor
Tahir Latif, MDPrincipal Investigator - University of Cincinnati
University of Cincinnati Physicians, Inc.
Allama Iqbal Medical College (Medical School)
Cleveland Clinic Fndn (Residency)

Media Library

Rituximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03688451 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: Intrathecal rituximab
Non-Hodgkin's Lymphoma Clinical Trial 2023: Rituximab Highlights & Side Effects. Trial Name: NCT03688451 — Phase 2
Rituximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03688451 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity of participants for this research endeavor?

"Affirmative. According to the clinicaltrials.gov, which last updated this study's information on October 25th 2019, this experiment is currently recruiting participants. A total of 20 people are required for testing at a single medical centre."

Answered by AI

Is this experiment seeking new participants?

"This medical research project is actively enrolling participants, with the original listing published on October 29th 2018 and its most recent update occurring in October 25th 2019."

Answered by AI

Could you please elucidate the risks of using Rituximab?

"Our experts at Power rated Rituximab's safety a 2, as the drug has only been trialled in Phase 2 trials and lacks clinical data proving its efficacy."

Answered by AI

In what clinical contexts is Rituximab typically recommended?

"Rituximab is regularly prescribed to those with diffuse large b-cell lymphoma (dlbcl) and can further be taken as a treatment for other varieties of B-cell lymphomas, polyangium, and pemphigus vulgaris."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intrathecal Rituximab With Standard Intrathecal Prophylaxis to Prevent CNS Relapse for CD 20+ Non Hodgkin Lymphoma
Tahir Latif 2018. "Intrathecal Rituximab With Standard Intrathecal Prophylaxis to Prevent CNS Relapse for CD 20+ Non Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03688451.
~3 spots leftby Apr 2025
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