Is NCT04045470 recruiting in Boston, MA?

Yes, NCT04045470 is currently recruiting participants at its Boston, MA location. This cutaneous t cell lymphoma clinical trial is actively enrolling qualified participants.

How do I join the cutaneous t cell lymphoma clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Cutaneous T Cell Lymphoma Clinical Trial in Boston, MA

About This Cutaneous T Cell Lymphoma Study in Boston

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

Sponsor: Dana-Farber Cancer Institute

Who Can Participate

Inclusion Criteria

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 Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT04045470) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Cutaneous T Cell Lymphoma Treatment Options in Boston, MA

If you're searching for cutaneous t cell lymphoma treatment options in Boston, MA, this clinical trial (NCT04045470) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced cutaneous t cell lymphoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cutaneous t cell lymphoma clinical trials near you to find additional studies recruiting in your area.

Cutaneous T Cell Lymphoma Clinical Trial in Boston, MA

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