What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, particularly those involving monoclonal antibodies targeting CD20 like rituximab, ofatumumab, and obinutuzumab, are associated with several side effects. These include infusion reactions, which can be severe, especially during the first cycle of treatment. Other side effects may include infections, hypomagnesemia, skin reactions, and sepsis. Additionally, combination therapies with agents like bendamustine can lead to hematologic toxicities such as neutropenia and thrombocytopenia. It is important to monitor patients closely and manage these side effects to ensure the safety and efficacy of the treatment.

What prior FDA approvals exist?

Rituximab, a monoclonal antibody targeting CD20 on B-cells, has been FDA-approved for the treatment of Non-Hodgkin's Lymphoma (NHL). It is often used in combination with chemotherapy regimens such as CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) and bendamustine. Other CD20-targeting monoclonal antibodies approved for NHL include ofatumumab and obinutuzumab. These therapies have shown efficacy in various clinical trials and are integral to the treatment landscape of NHL.

What other types of research exist?

Promising novel alternatives to Rituximab for Non-Hodgkin's Lymphoma patients include Obinutuzumab, a glycoengineered type II anti-CD20 monoclonal antibody, and Acalabrutinib, a selective Bruton tyrosine kinase (BTK) inhibitor. Both have demonstrated efficacy in clinical trials and offer different mechanisms of action compared to Rituximab.

← Back to Search

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

Must not have

History of spinal surgery and/or ineligible for intrathecal injections.

Primary central nervous system lymphoma or established secondary central nervous system disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 months

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing if rituximab can be safely given directly into the spinal fluid along with methotrexate. It targets patients with cancers affecting the central nervous system. Rituximab helps the immune system find and destroy cancer cells, while methotrexate kills them directly.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had spinal surgery or cannot receive spinal injections.

Select...

My cancer is in the brain or has spread to the brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Gastrointestinal intolerance

Impaired liver function test

100%

80%

60%

40%

20%

Study treatment Arm

Azathioprine

Rituximab

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include monoclonal antibodies like rituximab, obinutuzumab, and ofatumumab, which target the CD20 antigen on B-cells, leading to their destruction. Bendamustine, a chemotherapy agent, causes DNA damage and cell death. These treatments are significant for NHL patients as they specifically target malignant B-cells, improving treatment efficacy and potentially reducing side effects compared to non-targeted therapies.