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Anti-metabolites

Biodynamic Imaging for Mycosis Fungoides (BDI Trial)

N/A

Recruiting

Led By Lawrence A Mark, MD, PhD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

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

Must have

Advanced disease as defined by Stage IB, II-A, II-B, III and IV; disease unresponsive to or contraindicated for skin directed therapy or otherwise a candidate for systemic therapy due to disease progression

Histologically confirmed diagnosis of mycosis fungoides (MF) T-cell lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after day 56 of study for each individual participant

Awards & highlights

BDI Trial Summary

This trial studies if a laser light-based imaging test can predict how well chemotherapy works for a type of skin cancer. 10 patients will be enrolled and their response to the chemotherapy monitored.

Who is the study for?

Adults over 18 with a confirmed diagnosis of mycosis fungoides (MF) T-cell lymphoma, at an advanced stage and not responding to skin treatments or needing systemic therapy due to disease progression. Participants must be in good physical condition with adequate organ function and no recent severe side effects from past cancer therapies. They cannot have CNS metastasis, psychiatric conditions affecting study compliance, prior gemcitabine treatment, or be on high-dose steroids.Check my eligibility

What is being tested?

The trial is testing if Biodynamic Imaging (BDI), a laser light-based test, can predict how well the chemotherapy drug gemcitabine works for treating mycosis fungoides. It's a single-arm study where all participants receive standard doses of gemcitabine while their tumor response is monitored using BDI before starting treatment.See study design

What are the potential side effects?

While this trial primarily focuses on imaging rather than drug effects, potential side effects from the chemotherapy drug gemcitabine may include flu-like symptoms, fatigue, nausea, rash, low blood cell counts increasing infection risk and bleeding problems.

BDI Trial Eligibility Criteria

Inclusion Criteria

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

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My disease is advanced and hasn't responded to skin treatments or needs systemic therapy.

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I have been diagnosed with mycosis fungoides T-cell lymphoma.

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All side effects from my previous cancer treatments are mild or gone.

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I am fully active or can carry out light work.

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I am 18 years old or older.

BDI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ biopsy samples are collected and imaged prior to each subject's initiation of standard of care gemcitabine treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~biopsy samples are collected and imaged prior to each subject's initiation of standard of care gemcitabine treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and biopsy samples are collected and imaged prior to each subject's initiation of standard of care gemcitabine treatment for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Development of phenotypic human MF biodynamic profiles

Secondary outcome measures

Percent of individual biodynamic profiles with cellular response correlating with individual clinical response.

BDI Trial Design

1Treatment groups

Experimental Treatment

Group I: Individuals undergoing SOC Gemcitabine Treatment for mycosis fungoides (MF) T-cell lymphomaExperimental Treatment1 Intervention

Standard of Care (SOC) treatment with gemcitabine in this setting is 1200 mg/m2 as a 30 minute infusion given intravenously on days 1, 8, and 15 of every 28-day treatment cycle. Standard dose reductions are expected in patients experiencing unacceptable toxic effects of treatment. All subjects will undergo standardized staging tests, with tumor stage defined according to established guidelines. For this study, three 6-mm x 4-mm dermal punch biopsies from one or more target lesions will be collected prior to treatment initiation and submitted for Biodynamic imaging (BDI). All patients will be considered off-study after completing cycle 2.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

981,752 Total Patients Enrolled

Purdue UniversityOTHER

224 Previous Clinical Trials

72,754 Total Patients Enrolled

Lawrence A Mark, MD, PhDPrincipal InvestigatorIndiana University

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03789864 — N/A

Cutaneous T-Cell Lymphoma Research Study Groups: Individuals undergoing SOC Gemcitabine Treatment for mycosis fungoides (MF) T-cell lymphoma

Cutaneous T-Cell Lymphoma Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT03789864 — N/A

Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03789864 — N/A

Frequently Asked Questions

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

Is this clinical trial open for enrollment?

"Affirmative. Clinicaltrials.gov's records indicate that this clinical research is currently enrolling participants and was initially posted on October 7th 2019. The aim is to enrol 10 patients at a solitary medical centre before the final edit date of May 3rd 2023."

Answered by AI

What is the scope of participation in this experiment?

"Yes, according to clinicaltrials.gov this medical study is actively enrolling participants. The trial was initially published on the 7th of October 2019 and recently updated on May 3rd 2023; currently seeking 10 volunteers from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides

Lawrence Mark 2019. "Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03789864.

All > Mycosis Fungoides