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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will test if pembrolizumab + gemcitabine is an effective treatment for mycosis fungoides/Sézary syndrome.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate

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

Gemcitabine

2017

Completed Phase 3

~2070

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,870 Total Patients Enrolled

Alison Moskowitz, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

10 Previous Clinical Trials

567 Total Patients Enrolled

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04960618 — Phase 2

Cutaneous T-Cell Lymphoma Research Study Groups: Participants with confirmed mycosis fungoides/Sezary syndrome

Cutaneous T-Cell Lymphoma Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT04960618 — Phase 2

Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04960618 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there multiple locations administering this trial throughout North America?

"This medical trial is currently operational in 15 different locations, including Montvale, Middletown and Uniondale. If you are planning to participate, it would be prudent to select a site closest to your residence so as to minimize travel costs."

Answered by AI

To what degree can Gemcitabine be hazardous for individuals?

"Our team has assigned Gemcitabine a score of 2, which reflects the fact that there is evidence to suggest it is safe but none yet to indicate its efficacy."

Answered by AI

What is the current enrollment capacity of this research project?

"Affirmative. Per the information found on clinicaltrials.gov, this investigation is actively searching for participants and has been since October 1st 2021. As of June 29th 2022, 28 subjects need to be enrolled across 15 different sites."

Answered by AI

In what medical scenarios is Gemcitabine most beneficial?

"Gemcitabine is a viable remedy for combating malignant neoplasms, unresectable melanoma, and cancers with high microsatellite instability."

Answered by AI

Is this clinical investigation accepting participants at the present time?

"Per records on clinicaltrials.gov, this research endeavor is currently recruiting participants. The investigation was initially posted in October of 2021 and most recently refreshed on June 29th 2022."

Answered by AI

What other experiments have been conducted with Gemcitabine?

"At the time of writing, there are 1368 Gemcitabine trials currently underway with 244 in Phase 3. Shanghai is home to most of these research studies, but 54125 medical sites around the world have been allocated clinical trialling for this drug."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab in Combination With Gemcitabine in People With Advanced Mycosis Fungoides or Sézary Syndrome

2021. "Pembrolizumab in Combination With Gemcitabine in People With Advanced Mycosis Fungoides or Sézary Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04960618.

All > Mycosis Fungoides