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Pilot Study of a Microdevice for Drug Screening in Cutaneous T-Cell Lymphoma

This study is testing a new microdevice designed to help doctors find the most effective treatments for cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL) that affects the skin. The microdevice, which is implanted directly into a cancerous skin lesion, can release up to 19 different drugs, including romidepsin, vorinostat, bexarotene, brentuximab vedotin, pralatrexate, and mogamulizumab. Researchers want to see if the microdevice can be safely inserted and removed, and if it can collect enough tissue to analyze. This is a pilot study, meaning it's the first time this device is being tested in patients. You may be able to join if you are an adult with a confirmed diagnosis of CTCL or PTCL with skin involvement and have measurable skin lesions. The study aims to enroll 20 participants, but its current status is unclear.

Study design
This is a pilot and feasibility study, meaning it's the first time this microdevice is being tested in patients. It plans to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 2 years after the microdevice is placed and removed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04045470

A Pilot of a Microdevice For In Situ Candidate Drug Screening in Cutaneous Lesions of T-Cell Lymphoma

Recruiting
NAAges 18+InterventionalDiagnostic
Dana-Farber Cancer Institute
~20 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:MicrodevicesStandard of care therapyStandard of care systemic therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To Quantify The Number Of Microdevice-Related Failures Or Adverse Events As Assessed By CTCAE v4.0 After Microdevice Placement and Removal
Measured over 2 years
+1 more outcome measured

Conditions

Cutaneous T Cell Lymphoma
Peripheral T Cell Lymphoma

Explore related trials

Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedPrimary Cutaneous T-Cell Non-Hodgkin Lymphoma

NCT04045470

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Dana Farber Cancer Institute

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Cecilia Larocca, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Cecilia Larocca, MD
[email protected]
617-632-6571
Email the study team

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Eligibility criteria

Inclusion

Participants must have clinical diagnosis of cutaneous T-cell lymphoma or peripheral T-cell lymphoma with cutaneous involvement supported by histological evaluation of skin lesions.
Participants must have measurable cutaneous disease, based on the modified Severity Weighted Assessment Tool (mSWAT; definition provided in appendix E). Skin lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Two lesions are amenable to placement of multiple devices in terms of lesion size and location, as assessed by dermatologist (minimum diameter of 1.5 cm).
Patient must have the following minimum washout period from previous treatments and cannot be on any systemic therapy at the time of implantation.
2 week from topical therapies of lesional skin selected for implantation
2 weeks from retinoids, interferons, vorinostat, romidepsin, therapeutic doses of oral corticosteroids (physiologic replacement doses of oral corticosteoids are allowed)
4 weeks from phototherapy
5 half-lives for systemic cytotoxic anticancer agents, monoclonal antibodies, and investigational therapy
12 weeks from local radiation therapy of lesional skin selected for implantation
15 weeks from systemic immunotherapy targeting PD-1/PD-L1
Age minimum of age 18.
ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
Participants will undergo laboratory testing within 28 days prior to the procedure. Participants must have marrow function as defined below:
absolute neutrophil count ≥500/mcL
platelets ≥50,000/mcL
Participants must be evaluated by a dermatologist or medical oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease. Systemic therapy will be mandatory for cohort 2/expansion cohort, not for cohort 1. Systemic therapy may be initiated anytime within 4 weeks of MD removal.
Patients must be deemed medically stable to undergo percutaneous procedures by their treating cutaneous oncologist.
Ability to understand and the willingness to sign a written informed consent document.
Patients must be willing to undergo research-related genetic and transcriptomic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.
Patient is considered to have capacity to properly follow instructions at home for the care of device(s) that will each have an attached thin guidewire protruding through the skin and fixed in place (see Appendix B).

Exclusion

Positive serum pregnancy test at screening visit.
Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures
History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study.
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 who will receive standard of care systemic therapy are not allowed to start any new skin directed therapy (e.g. topical steroids, radiation, phototherapy) concurrent with first systemic therapy initiated after device implantation and retrieval. Should a patient clinically progress on first systemic therapy and require a change in treatment, skin directed therapies may be introduced.
Patients unable to undergo treatment wash-out period due to rapidly progressive disease requiring immediate systemic therapy

What this trial measures

  • To Quantify The Number Of Microdevice-Related Failures Or Adverse Events As Assessed By CTCAE v4.0 After Microdevice Placement and Removal2 years

    "Failure" will be considered any of the following: 1. Any grade 3 or 4 adverse events associated with device placement or retrieval 2. Any device resulting in "major" adverse events as listed below: * device unable to be found or unable to be retrieved * device invading into vessel or device embolism * infection or severe tissue damage or abnormal wound healing associated with device or procedure (as deemed by a neutral consultant e.g. dermatologist, ID specialist or surgeon) * severe allergic/hypersensitivity reaction * severe bleeding 3. Any device resulting in \*two or more\* "minor" adverse events as listed below: * device migration more than 10 mm * device fracture not causing a major adverse event * mild allergic/hypersensitivity reaction * manageable pain associated with biopsy procedure * minor bleeding For purposes of this endpoint, safety will be evaluated on a per-patient level, where an event is defined as any "failure" observed among all implanted devices.

  • To Retrieve The Device With Sufficient Tissue Of Sufficient Quality2 years

    For the feasibility endpoint, a "successful" procedure will be defined as the ability to retrieve the device (by either skin punch biopsy tool or surgical excision) without damaging tumor tissue surrounding the microdevice to allow for immunohistochemistry analysis. For purposes of this endpoint, feasibility will be assessed on a per-device basis rather than a per-patient basis, with each device considered relatively independent in terms of placement, retrieval, and analysis.