Clinical trial NCT05106192: Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.
Official title: Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mycosis Fungoides of Skin (Diagnosis)
Cutaneous T-cell Lymphoma
Non Hodgkin Lymphoma
Lymphomatoid Papulosis
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Follicular
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain measurement between the Med-Jet and standard of care treatment.
timeFrame: 1.5 Hour after the treatment
Secondary outcomes:
measure: Participants Preference
timeFrame: 3 Months
measure: Tolerability of Pruritus
timeFrame: At Baseline, 1 month, 2 months, and 3 months
measure: Quality of life due to skin conditions
timeFrame: 3 Months
measure: CAILS assessment of clinical efficacy
timeFrame: At Baseline, 1 month, 2 months, and 3 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Kevin Cooper, MD
role: PRINCIPAL_INVESTIGATOR
References: