What side effects are associated with this type of intervention?

Common treatments for Cutaneous T-Cell Lymphoma (CTCL) include immune checkpoint inhibitors like Pembrolizumab and chemotherapeutic agents like Gemcitabine. Pembrolizumab, a PD-1 inhibitor, can cause immune-related adverse events such as colitis, hepatitis, pneumonitis, endocrinopathies, and skin reactions. Gemcitabine, a nucleoside analog chemotherapy, is associated with side effects like myelosuppression, nausea, vomiting, rash, and elevated liver enzymes. Both treatments require careful monitoring due to their potential toxicities.

What prior FDA approvals exist?

For the treatment of Cutaneous T-Cell Lymphoma (CTCL), the FDA has approved several therapies. Notably, Pembrolizumab, a PD-1 inhibitor, is being studied for its efficacy in CTCL. Other FDA-approved treatments include Brentuximab Vedotin, an antibody-drug conjugate targeting CD30, and Romidepsin, a histone deacetylase inhibitor. Gemcitabine, a nucleoside analog chemotherapy, is also under investigation for its potential benefits in combination therapies for CTCL. These treatments aim to target the malignant T-cells and improve patient outcomes.

What other types of research exist?

Promising novel alternatives for Cutaneous T-Cell Lymphoma patients include: 1) Mogamulizumab (anti-CCR4 monoclonal antibody), 2) Brentuximab vedotin (anti-CD30 antibody-drug conjugate), and 3) Lacutamab (anti-KIR3DL2 monoclonal antibody). These therapies have shown efficacy in clinical trials and are emerging as potential treatments for CTCL.

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Anti-metabolites

Pembrolizumab + Gemcitabine for Cutaneous T-Cell Lymphoma

Phase 2

Recruiting

Led By Alison Moskowitz, 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

Receipt of at least one prior systemic therapy for MF/SS

Age ≥ 18 years

Must not have

Known active CNS lymphoma

Known history of active TB

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, pembrolizumab and gemcitabine, to treat patients with mycosis fungoides and Sézary syndrome. Pembrolizumab helps the immune system attack cancer, while gemcitabine kills cancer cells directly. The goal is to see if this combination is more effective than current treatments. IPH4102 is a new antibody specifically developed for treating cutaneous T-cell lymphoma.

Who is the study for?

Adults over 18 with mycosis fungoides or Sézary syndrome, who have tried at least one systemic therapy before, can join this trial. They should be relatively healthy (ECOG score 0-1) and not have had certain treatments recently. People with organ transplants, other active cancers, severe infections, or immune conditions that need treatment are excluded.

What is being tested?

The trial is testing if pembrolizumab combined with gemcitabine works for advanced mycosis fungoides and Sézary syndrome. Participants will receive both drugs to see how effective they are together in treating these conditions.

What are the potential side effects?

Pembrolizumab and gemcitabine may cause side effects like allergic reactions, fatigue, nausea, low blood cell counts increasing infection risk. Pembrolizumab might also lead to autoimmune-like symptoms due to immune system activation.

Eligibility Criteria

Inclusion Criteria

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

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I have received at least one treatment for my cutaneous T-cell lymphoma.

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I am 18 years old or older.

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I am not pregnant, not breastfeeding, and follow birth control guidelines.

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I can carry out all my daily activities without help.

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My condition is confirmed as mycosis fungoides/Sezary syndrome, stage IB or higher.

Exclusion Criteria

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

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I have been diagnosed with active lymphoma in my brain or spinal cord.

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I have an active case of tuberculosis.

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I have another cancer that is getting worse or was treated in the last year.

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I have been treated with cancer-fighting drugs before.

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I have a history of HIV infection.

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I have or had lung inflammation that needed steroids.

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I am currently being treated for an infection.

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I have an active Hepatitis B or C infection.

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I have received an organ or tissue transplant from another person.

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I have an immune system disorder or I am on long-term steroids.

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I have been treated for an autoimmune disease in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

Overall Response Rate

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 confirmed mycosis fungoides/Sezary syndromeExperimental Treatment2 Interventions

Participants will have confirmed mycosis fungoides/Sezary syndrome, disease stage IB (defined as patches, plaque, or papules that involve 10% of the skin surface viscera) or higher.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Gemcitabine

2017

Completed Phase 3

~1920

0 / 16Eligibility 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

Pembrolizumab, a PD-1 inhibitor, reactivates T-cells by blocking the PD-1 pathway, which cancer cells use to evade the immune system, thereby enabling the immune system to attack the cancer. Gemcitabine, a nucleoside analog chemotherapy, disrupts DNA synthesis, causing cell death in rapidly dividing cells, including cancer cells. This dual approach of boosting immune response and directly targeting cancer cell replication is significant for Cutaneous T-Cell Lymphoma patients as it may lead to more effective treatment outcomes.