What other types of research exist?

Promising novel alternatives for Cutaneous T-Cell Lymphoma (CTCL) patients include Mogamulizumab, a monoclonal antibody targeting CCR4, and Pembrolizumab, an immune checkpoint inhibitor targeting PD-1. Both have shown efficacy in recent clinical trials and represent new therapeutic options for CTCL.

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Monoclonal Antibodies

Romidepsin + Brentuximab Vedotin for Cutaneous T-Cell Lymphoma

Q: What side effects are associated with this type of intervention?

Romidepsin, a histone deacetylase inhibitor, commonly causes side effects such as nausea, vomiting, fatigue, infections, and hematologic abnormalities like thrombocytopenia and neutropenia. Brentuximab Vedotin, an antibody-drug conjugate targeting CD30, is associated with peripheral neuropathy, neutropenia, fatigue, nausea, and upper respiratory tract infections. Both treatments require careful monitoring due to their potential toxicities.

Q: What prior FDA approvals exist?

Romidepsin, an HDAC inhibitor, was approved by the FDA for the treatment of Cutaneous T-Cell Lymphoma (CTCL) in 2009. Another HDAC inhibitor, Vorinostat, was approved in 2006 for CTCL. Brentuximab Vedotin, an antibody-drug conjugate targeting CD30, received FDA approval in 2011 for the treatment of systemic anaplastic large cell lymphoma and later for CTCL in 2017. These approvals highlight the use of targeted therapies in managing CTCL.

Phase 1

Waitlist Available

Led By Shazia Nakhoda, MD

Research Sponsored by Fox Chase Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients must have histologically or cytologically confirmed diagnosis of mycosis fungoides (MF), Sezary syndrome (SS) or primary cutaneous CD30-positive lymphoproliferative disorder, including lymphomatoid papulosis and primary cutaneous ALCL (pc-ALCL) as defined by the WHO classification of Tumors of Hematopoietic and Lymphoid tissue.

Patients with MF/SS must have stage IB, IIA, IIB, III or IV disease; patients with primary cutaneous CD30-positive lymphoproliferative disorder must have multifocal symptomatic or extensive lesions requiring systemic treatment.

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Patients with known CNS involvement.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of patient registration until death, measured every 12 weeks up to 2 years

Awards & highlights

Summary

This trial is testing if two drugs, Romidepsin and Brentuximab Vedotin, can be safely used together to treat a type of skin cancer called Cutaneous T-cell Lymphoma. It targets patients who need systemic therapy and may have tried other treatments before. Romidepsin stops cancer growth, and Brentuximab Vedotin helps the immune system kill cancer cells.

Who is the study for?

This trial is for adults over 18 with Cutaneous T-cell Lymphoma needing systemic therapy. Eligible patients can have had up to two prior treatments (excluding PUVA), must have certain levels of organ and marrow function, and no severe side effects from previous cancer therapies. HIV-positive patients can join if they meet specific health criteria.

What is being tested?

The study tests the combination of Romidepsin and Brentuximab Vedotin in treating Cutaneous T-cell Lymphoma. It's a Phase I trial, which means it's an early-stage study focusing on the feasibility and safety of this drug combo.

What are the potential side effects?

Potential side effects may include changes in blood counts, liver enzymes alterations, possible kidney function issues, fatigue, nausea, or allergic reactions related to the drugs being tested.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with a specific type of skin lymphoma.

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My skin cancer is at an advanced stage or requires systemic treatment due to extensive lesions.

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I can take care of myself and am up and about more than half of my waking hours.

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I am a woman who can have children and I have a negative pregnancy test.

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I have HIV, but it's well-controlled, and I'm not on certain medications.

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My kidney function, measured by creatinine levels, is normal or nearly normal.

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I am older than 18 years.

Exclusion Criteria

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

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I do not have any serious illnesses that would stop me from following the study's requirements.

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My cancer has spread to my brain.

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I experience significant numbness or pain due to nerve damage.

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My side effects from previous cancer treatments are mild or gone.

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I am not using steroids or skin treatments while in this study, except as allowed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of patient registration until death, measured every 12 weeks up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of patient registration until death, measured every 12 weeks up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of patient registration until death, measured every 12 weeks up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose-limiting toxicities (DLTs)

Maximum tolerated dose (MTD)

Secondary study objectives

Estimate complete and partial response rate of the combination treatment

Overall survival (OS)

Progression free survival (PFS)

+1 more

Side effects data

From 2018 Phase 1 & 2 trial • 51 Patients • NCT01456039

100%

Dysgeusia

100%

Leukopenia

100%

Thrombocytopenia

100%

Lymphopenia

100%

Neutropenia

100%

Nausea

100%

Vomiting

100%

Pyrexia

100%

Fatigue

100%

Decreased appetite

100%

Peripheral Sensory neuropathy

67%

Diarrhoea

67%

Anaemia

67%

Lip dry

67%

Haemoglobin decreased

67%

Weight decreased

67%

Blood phosphorus increased

67%

Hypotension

67%

Insomnia

33%

Akathisia

33%

Alanine aminotransferase increased

33%

Oedema peripheral

33%

Cancer Pain

33%

Hypocalcaemia

33%

Hyperhidrosis

33%

Hypokalaemia

33%

Vitreous Floaters

33%

Biliary colic

33%

Abdominal pain upper

33%

Dental caries

33%

Gastritis

33%

Hypothermia

33%

Influenza like illness

33%

Non-cardiac chest pain

33%

Hypermagnesaemia

33%

Hyperuricaemia

33%

Blood alkaline phosphatase increased

33%

Blood urea increased

33%

Somnolence

33%

Rash macular

33%

Hypoxia

33%

Arthralgia

33%

Back Pain

33%

Musculoskeletal stiffness

33%

Osteoarthritis

33%

Periarthritis

33%

Nasopharyngitis

33%

Influenza

33%

Upper respiratory tract infection

33%

Long QT syndrome

33%

Contusion

33%

Procedural Pain

33%

Phlebitis

33%

Pollakiuria

33%

Headache

33%

Hiccups

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1: Romidepsin 9mg/m^2

Phase 1: Romidepsin 14mg/m^2

Phase 2: Romidepsin 14mg/m^2

Total: Romidepsin 14mg/m^2

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment2 Interventions

Treatment consists of the combination of Romidepsin given 10mg/m2 or 14mg/m2 on days 1, 8 and 15 every 28 days and Brentuximab vedotin given 0.9mg/kg or 1.2mg/kg on days 1 and 15 every 28 days for 16 cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Romidepsin

2011

Completed Phase 2

~790

Brentuximab vedotin

2012

Completed Phase 2

~200

0 / 12Eligibility 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

Romidepsin, a Histone Deacetylase (HDAC) inhibitor, works by altering gene expression to induce cancer cell death, while Brentuximab Vedotin, an antibody-drug conjugate targeting CD30, delivers a cytotoxic agent directly to cancer cells. These targeted mechanisms are significant for Cutaneous T-Cell Lymphoma patients as they offer the potential for more effective and less toxic treatments.