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New treatment option for Cutaneous T Cell Lymphoma
Official title A Pilot of a Microdevice For In Situ Candidate Drug Screening in Cutaneous Lesions of T-Cell Lymphoma
ClinicalTrials.gov ID: NCT04045470
What this study is testing
- What it's testing
- This research is being done to study the safety of implanting and retrieving a microdevice that releases up to 19 drugs directly within a cancerous lesion as a possible tool to evaluate the effectiveness of several approved cancer drugs against cutaneous T cell lymphoma and peripheral T cell lymphoma
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have clinical diagnosis of cutaneous T-cell lymphoma or peripheral T-cell lymphoma with cutaneous involvement supported by...
- Participants must have measurable cutaneous disease, based on the modified Severity Weighted Assessment Tool (mSWAT; definition provided in appendix...
- 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...
- 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
You likely can't join if
- 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...
- Patients who will receive standard of care systemic therapy are not allowed to start any new skin directed therapy (e.g. topical steroids, radiation...
- Patients unable to undergo treatment wash-out period due to rapidly progressive disease requiring immediate systemic therapy
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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).
What rules you out
- 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...
- 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...
- Patients unable to undergo treatment wash-out period due to rapidly progressive disease requiring immediate systemic therapy
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.