What is the mechanism of action of this treatment?

Monoclonal antibodies, such as Rituximab, are a common treatment for Lymphoma. They work by targeting specific antigens like CD20 on B-cells, leading to cancer cell death through mechanisms such as antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and direct induction of apoptosis. This targeted approach helps minimize damage to normal cells, reducing side effects and improving patient outcomes. Understanding these mechanisms is important for Lymphoma patients as it helps in selecting treatments that effectively target cancer cells while preserving overall health.

What side effects are associated with this type of intervention?

Common treatments for lymphoma, particularly monoclonal antibodies like rituximab, ofatumumab, and obinutuzumab, are associated with several side effects. These include infusion reactions, which can be severe during the first cycle, neutropenia, increased risk of infections, and hypersensitivity reactions. When combined with chemotherapy agents like bendamustine, additional side effects such as myelosuppression, nausea, and fatigue are also common.

What prior FDA approvals exist?

Several monoclonal antibodies have been approved by the FDA for the treatment of lymphoma. These include rituximab, ofatumumab, and obinutuzumab, which target CD20 and are used in various regimens for B-cell prolymphocytic leukemia (B-PLL) and chronic lymphocytic leukemia (CLL). Additionally, brexucabtagene autoleucel, a CAR-T cell therapy targeting CD19, has been approved for relapsed or refractory mantle cell lymphoma. These treatments are similar to the monoclonal antibody Xisomab 3G3 being studied for preventing thrombosis in cancer patients.

What other types of research exist?

Promising novel alternatives to Xisomab 3G3 for lymphoma patients include: 1) Lumiliximab (anti-CD23) and Ofatumumab (HuMax CD20), which are under active study for chronic lymphocytic leukemia and may have applications in lymphoma. 2) Ibrutinib and Venetoclax, which are targeted therapies showing efficacy in chronic lymphocytic leukemia and may be considered for lymphoma treatment. 3) Pembrolizumab and Avelumab, which are PD-1 and PD-L1 inhibitors being evaluated in various cancers and may offer benefits for lymphoma patients.

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Monoclonal Antibodies

Xisomab 3G3 for Blood Clot Prevention in Cancer Patients

Phase 2

Waitlist Available

Led By Joseph Shatzel, M.D.

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from xisomab 3g3 infusion up to end of treatment visit (day 18)

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well Xisomab 3G3 prevents blood clots in cancer patients with catheters receiving chemotherapy. The drug helps stop clot-forming proteins, reducing the risk of clots. This is important because these patients often develop painful and risky blood clots.

Who is the study for?

This trial is for adults with solid cancers like lymphoma or multiple myeloma who need a central venous catheter for chemotherapy. They must be in fairly good health, not on blood thinners, and have no major bleeding risks or recent thrombosis. Women of childbearing age must test negative for pregnancy and agree to use contraception.

What is being tested?

The study tests Xisomab 3G3's effectiveness at preventing blood clots in patients with cancer receiving chemo through a catheter. It's a phase II trial where the drug, an antibody designed to stop clots from forming around the catheter site, will be given before starting standard cancer therapy.

What are the potential side effects?

Potential side effects of Xisomab 3G3 may include allergic reactions due to hypersensitivity to the drug or its components. Since it aims to prevent clotting, there might also be an increased risk of bleeding complications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from xisomab 3g3 infusion up to end of treatment visit (day 18)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from xisomab 3g3 infusion up to end of treatment visit (day 18)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from xisomab 3g3 infusion up to end of treatment visit (day 18) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Catheter-associated Thrombosis (CAT)

Secondary study objectives

Incidence of Major and Clinically-relevant Bleeding

Incidence of Xisomab 3G3-associated Adverse Events (AEs)

Other study objectives

Proportion of Patients That Had a Catheter Occlusion Requiring Medical Intervention

Quantification of Coagulation Measures: Activated Partial Thromboplastin Time (aPTT)

Quantification of Coagulation Measures: Platelet Count

+4 more

Awards & Highlights

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: Supportive Care (xisomab 3G3)Experimental Treatment1 Intervention

Patients receive xisomab 3G3 IV or via catheter within 48 hours of catheter placement. Patients then receive standard of care chemotherapy 2 days later. After approximately 2 weeks, patients undergo standard of care ultrasound for possible CAT.

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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

Monoclonal antibodies, such as Rituximab, are a common treatment for Lymphoma. They work by targeting specific antigens like CD20 on B-cells, leading to cancer cell death through mechanisms such as antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and direct induction of apoptosis. This targeted approach helps minimize damage to normal cells, reducing side effects and improving patient outcomes. Understanding these mechanisms is important for Lymphoma patients as it helps in selecting treatments that effectively target cancer cells while preserving overall health.