Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.

Case Comprehensive Cancer Center (Case CCC)

Status: Withdrawn

Conditions: Lymphoma, Large-Cell, Anaplastic; Cutaneous T-cell Lymphoma; Lymphoma, Follicular; Lymphomatoid Papulosis; Non Hodgkin Lymphoma; Mycosis Fungoides of Skin (Diagnosis)

Treatments: Drug: Triamcinolone Acetonide; Device: Med-Jet Injector; Drug: Bexarotene 1% Top Gel; Drug: Nitrogen Mustard; Device: Conventional syringe

Study type: Interventional

Funder types: Other

Identifiers

NCT05106192

CASE4621

Details and patient eligibility

About

A study to compare pain differences between using MedJet needle-free drug-delivery system with standard of care treatment for cutaneous T-cell lymphomas and cutaneous B-cell lymphomas in participants.

Full description

Participants will undergo treatments on two morphologically and anatomically matched target lesions, preferably on opposing sides of the body.

The first plaque will be treated using standard of care topical bexarotene or nitrogen mustard for participants with CTCL (cutaneous T-cell lymphomas) or intralesional TAC (triamcinolone acetonide) using a syringe/needle with participants with CBCL (cutaneous B-cell lymphomas).

The second plaque will be treated using a needle-free injector system. After the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded.

In order to account for 20% dropout, 11 patients per group (a needle free and a traditional treatment group in CBCL patients and the same two groups in CTCL patients) will be recruited.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. > 18 years of age

2. Diagnosed with primary cutaneous lymphoma defined by either:

   • A board-certified dermatologist, OR
   • Dermatology Nurse Practitioner, OR
   • Skin punch biopsy

3. The presence of plaque-type primary cutaneous lymphoma lesions with at least two plaques that are at least two cm² in areas of the trunk, buttocks, or extremities that are either:

   • Symmetrically located on contralateral body site OR
   • Within the same body site but separated by ≥ 1 cm
   • Both plaques must be similar in size as much as possible

4. Able to give informed consent under IRB approval procedures

Exclusion criteria

1. Known allergy or hypersensitivity to triamcinolone acetonide
2. Known allergy to topical bexarotene or topical nitrogen mustard
3. Pregnant, breastfeeding, or planning to get pregnant 4 weeks before, during, and 4 weeks after the study.
4. Inability to provide informed consent
5. Diagnosis of erythrodermic mycosis fungoides or Sezary syndrome
6. Use of topical corticosteroids to target lesions within 1 week prior to baseline visit
7. Use of radiation therapy to target lesions within 1 week prior to baseline visit

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Cutaneous T-cell lymphomas (CTCL) Participants

Experimental group

Description:

The first plaque will be treated using standard of care topical bexarotene or nitrogen mustard for participants with CTCL (cutaneous T-cell lymphomas) The second plaque will be treated using a needle-free injector system. After the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded.

Treatment:

Drug: Nitrogen Mustard

Drug: Bexarotene 1% Top Gel

Device: Med-Jet Injector

Drug: Triamcinolone Acetonide

Cutaneous B-cell lymphomas (CBCL) Participants

Experimental group

Description:

The first plaque will be treated using standard of care intralesional TAC (triamcinolone acetonide) using a syringe/needle with participants with CBCL (cutaneous B-cell lymphomas). The second plaque will be treated using a needle-free injector system. After the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded.

Treatment:

Device: Conventional syringe

Device: Med-Jet Injector

Drug: Triamcinolone Acetonide