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Monoclonal Antibodies
BMS-986458 + Rituximab for Non-Hodgkin Lymphoma
Phase 1 & 2
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For R/R DLBCL (de novo) and FL 3b: following at least 2 prior lines of therapy (eg, first-line combination chemotherapy regimen containing rituximab, anthracycline, an alkylating agent, and steroids and at least one additional treatment).
For R/R DLBCL (transformed lymphoma): following at least 2 prior lines of therapy which must have been administered after transformation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called BMS-986458 to see if it is safe and effective for patients whose non-Hodgkin Lymphoma has come back or didn't respond to other treatments. The study will look at how well the drug works alone and with other cancer-fighting drugs.
Who is the study for?
This trial is for people with Non-Hodgkin Lymphoma who have tried at least two prior treatments. They must have a type of lymphoma that shows up on certain body scans and agree to follow a pregnancy prevention plan.
What is being tested?
The study tests BMS-986458, both alone and combined with other anti-lymphoma drugs like Rituximab, to see how safe it is and if it works against relapsed/refractory non-Hodgkin Lymphoma.
What are the potential side effects?
Possible side effects include reactions where the drug enters the body, changes in blood counts, fatigue, nausea, fever, rash or itching. Each person's reaction to the treatment can vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least 2 treatments for my lymphoma, including chemotherapy with rituximab.
Select...
I have had at least 2 treatments for my transformed lymphoma.
Select...
I have at least one tumor that can be measured and is larger than 1.5 cm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Part B2Experimental Treatment2 Interventions
Combination Treatment
Group II: Part B1Experimental Treatment1 Intervention
Single Agent
Group III: Part A2Experimental Treatment2 Interventions
Combination Treatment
Group IV: Part A1Experimental Treatment1 Intervention
Single Agent
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~2990
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
Non-Hodgkin's Lymphoma (NHL) treatments often include monoclonal antibodies, chemotherapy, and targeted therapies. Monoclonal antibodies, such as rituximab, target specific proteins on the surface of lymphoma cells, marking them for destruction by the immune system.
Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancerous lymphocytes. Targeted therapies, like BTK inhibitors (e.g., ibrutinib), interfere with specific molecular pathways crucial for the survival and proliferation of lymphoma cells.
Novel agents like BMS-986458 are being studied for their ability to target unique pathways or cellular mechanisms involved in NHL. These treatments are crucial as they offer more precise and potentially less toxic options, improving outcomes and quality of life for NHL patients.
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Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,696 Previous Clinical Trials
4,098,798 Total Patients Enrolled