What side effects are associated with this type of intervention?

Common treatments for blood cancers, such as monoclonal antibodies and tyrosine kinase inhibitors (TKIs), often have side effects including infusion reactions, fatigue, and increased risk of infections. Specific monoclonal antibodies like rituximab can cause serum-sickness-like reactions and infusion-related reactions, while TKIs like ibrutinib may lead to diarrhea, skin rashes, and hypertension. Chemotherapy, another common treatment, can result in nausea, hair loss, and bone marrow suppression, leading to anemia, increased infection risk, and bleeding issues.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibodies for the treatment of blood cancers. Rituximab, an anti-CD20 monoclonal antibody, is widely used for treating non-Hodgkin lymphoma and chronic lymphocytic leukemia. Obinutuzumab, another anti-CD20 antibody, is approved for chronic lymphocytic leukemia and follicular lymphoma. Additionally, Brentuximab vedotin, an anti-CD30 antibody-drug conjugate, is approved for Hodgkin lymphoma and systemic anaplastic large cell lymphoma. These treatments, like Benralizumab, target specific cells or pathways to manage blood cancers effectively.

What other types of research exist?

Promising novel alternatives to Benralizumab for blood cancer patients include: 1) Elotuzumab combined with lenalidomide and dexamethasone for relapsed/refractory multiple myeloma, 2) Daratumumab combined with bortezomib and dexamethasone for multiple myeloma, 3) Ibrutinib for chronic lymphocytic leukemia and mantle cell lymphoma, 4) Venetoclax combined with obinutuzumab for chronic lymphocytic leukemia, and 5) Acalabrutinib for mantle cell lymphoma. These therapies have shown significant efficacy in clinical trials and are considered promising options for treatment in 2024.

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Benralizumab for Cancer-related Skin Side Effects

Phase 2

Waitlist Available

Led By Alina Markova, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

- Immunotherapies: ipilimumab, nivolumab, pembrolizumab, avelumab, durvalumab, atezolizumab tremelimumab.

Patients must have a therapy-related CTCAE grade 2/3 cutaneous adverse event defined as any cutaneous reaction listed below and blood eosinophil counts of at least .3 K/mcl.

Must not have

Patients cannot use new topicals or medications for indication of pruritus or skin rash

Patients receiving prednisone ≥ 20mg a day.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing benralizumab, a drug that aims to reduce skin problems caused by cancer treatments. It works by lowering certain cells in the blood that cause these issues. The goal is to improve patients' quality of life and help them continue their cancer therapy.

Who is the study for?

Adults aged 18-85 with blood or solid cancers experiencing grade 2/3 skin side effects from cancer therapies like immunotherapies or targeted therapies, and have a certain level of eosinophils in their blood. They must be able to continue their current cancer treatment, have good organ function, and not be pregnant or breastfeeding. Effective birth control is required for those who can bear children.

What is being tested?

The trial tests if benralizumab can safely reduce skin side effects caused by cancer treatments by lowering blood eosinophil levels. This could improve life quality and allow patients to maintain their usual cancer therapy regimen.

What are the potential side effects?

Potential side effects are not detailed here but may include reactions similar to other biologic therapies such as allergic responses, injection site reactions, and possible impacts on the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have received treatments like ipilimumab or pembrolizumab.

Select...

I have a skin reaction from treatment and my blood test shows high eosinophils.

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I am taking alpelisib for a growth disorder linked to PIK3CA.

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I am fully active or can carry out light work.

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I can receive shots under my skin.

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My blood counts meet the required levels without transfusions.

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I have had both ovaries and fallopian tubes surgically removed.

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I have had a hysterectomy.

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I have had both of my fallopian tubes surgically removed.

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My cancer has been confirmed by lab tests.

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My kidney function, measured by creatinine levels, is within the normal range.

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I have not had a menstrual period for at least one year.

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I have a flat or slightly raised spotted rash.

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I have had both of my ovaries surgically removed.

Exclusion Criteria

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

Select...

I am not using new creams or medications for itchiness or rash.

Select...

I am taking 20mg or more of prednisone daily.

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I have used anti-IL-5 drugs or biologics for asthma.

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I have HIV or hepatitis B/C that needs antiviral treatment.

Select...

I am not pregnant or breast-feeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percent reduction in CTCAE grade 2/3 eosinophil-related cutaneous adverse events

Side effects data

From 2016 Phase 3 trial • 220 Patients • NCT02075255

15%

Nasopharyngitis

Asthma

Sinusitis

Headache

Bronchitis

Upper respiratory tract infection

Influenza

Back pain

Cough

Dyspnoea

Hypertension

Rhinitis

Urosepsis

Nephrolithiasis

Intervertebral disc protrusion

Umbilical hernia

Adverse drug reaction

Hypersensitivity

Vertigo

Nausea

Dermatitis atopic

Urinary tract infection bacterial

100%

80%

60%

40%

20%

Study treatment Arm

Benra 30 mg q.4 Weeks

Benra 30 mg q.8 Weeks

Placebo

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: Participants with eosinophil-related cutaneous eventsExperimental Treatment1 Intervention

Study participants will have grade 2/3 eosinophil-related cutaneous adverse events

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Benralizumab

2016

Completed Phase 4

~10320

0 / 19Eligibility 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

Common treatments for blood cancers include chemotherapy, targeted therapy, immunotherapy, and stem cell transplantation. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells. Targeted therapies, such as tyrosine kinase inhibitors, specifically inhibit cancer cell growth by targeting molecular abnormalities. Immunotherapies, including monoclonal antibodies like Benralizumab, enhance the immune system's ability to recognize and destroy cancer cells. Benralizumab, for instance, targets eosinophils, reducing inflammation and potentially improving the efficacy of cancer treatments. These therapies are crucial for blood cancer patients as they offer more precise and effective treatment options, often with fewer side effects compared to traditional chemotherapy.

Current Landscape of Targeted Therapy in Hormone Receptor-Positive and HER2-Negative Breast Cancer.Regorafenib-associated hand-foot skin reaction: practical advice on diagnosis, prevention, and management.