Lymphoma Trial, Recruiting NCT04045470 Sponsor: Dana-Farber Cancer Institute Condition: Lymphoma
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Lymphoma Trial, Recruiting

NCT04045470
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been clinically diagnosed with cutaneous T-cell lymphoma or peripheral T-cell lymphoma that affects the skin, confirmed by a laboratory examination of skin tissue samples.
  • People who have measurable areas of skin disease, as assessed using a specific skin scoring tool called the mSWAT (including skin lesions in previously treated areas, if those lesions have continued to grow).
  • People who have at least two skin lesions that are large enough and in a suitable location for small devices to be placed in them — each lesion must be at least 1.5 cm across, as confirmed by a dermatologist.
  • People who have waited long enough after previous treatments before joining the trial — specific waiting periods apply depending on the type of treatment previously received (confirm exact waiting times with the trial site), and no systemic (whole-body) therapy may be ongoing at the time the devices are placed.
  • People aged 18 or older.
  • People who are reasonably well and able to carry out daily activities, as measured by a standard health scoring scale (confirm with trial site).
  • People whose recent blood test results (taken within 28 days before the procedure) show that their bone marrow is producing enough blood cells — specifically, a minimum level of infection-fighting cells and platelets.
  • People who have been assessed by a dermatologist or cancer specialist, who will determine the most appropriate treatment plan based on their medical history and how far the disease has spread.
  • People who their treating skin cancer specialist considers medically stable enough to safely undergo a minor procedure where a device is inserted through the skin.
  • People who are able to understand and are willing to sign a written consent form agreeing to take part in the trial.
  • People who are willing to have their genetic material analysed for research purposes, including having de-identified genetic data stored in approved government health research databases.
  • People who are considered capable of following care instructions at home for the small devices, which will have a thin wire protruding through the skin while in place.

Who may not be able to join:

  • People who have a positive pregnancy test at the screening visit.
  • People who have a bleeding or blood-clotting disorder that cannot be corrected and that is known to increase the risk of surgical or biopsy procedures.
  • People who have a history of allergic reactions to substances that are chemically or biologically similar to the agents used in this trial.
  • People who have an uncontrolled ongoing illness — such as an active infection, heart failure, unstable chest pain, irregular heart rhythms, or a mental health or personal situation that would make it difficult to follow the trial's requirements.
  • People who are receiving standard whole-body (systemic) cancer treatment as part of the trial and who would need to start a new skin-directed treatment (such as steroid creams, radiation, or light therapy) at the same time as the first systemic therapy given after the devices are placed and removed. (Skin-directed therapies may be considered later if the disease worsens and treatment needs to change — confirm with trial site.)
  • People whose disease is progressing so rapidly that they need to start whole-body (systemic) treatment immediately and cannot wait out the required treatment washout period.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Cecilia Larocca, MD, Dana-Farber Cancer Institute

Phone: 617-632-6571

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
11 December 2019
Est. completion
31 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To Quantify The Number Of Microdevice-Related Failures Or Adverse Events As Assessed By CTCAE v4.0 After Microdevice Placement and Removal; To Retrieve The Device With Sufficient Tissue Of Sufficient Quality

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov