Phototherapy and Mogamulizumab in Early Stage MF (PLIGHT) (NCT06235281) | Clinical Trial Compass
SuspendedEarly Phase 1
Phototherapy and Mogamulizumab in Early Stage MF (PLIGHT)
Stopped: Slow Accrual
United States20 participantsStarted 2024-01-18
Plain-language summary
This is an open label, single arm, single-center, pilot study of concurrent phototherapy and POTELIGEO (mogamulizumab-kpkc) in early-stage mycosis fungoides.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Be willing and able to provide written informed consent/assent for the trial.
* Be at least 18 years of age on day of signing informed consent.
* Able to adhere to the study visit schedule and other protocol requirements.
* Diagnosis of mycosis fungoides (MF) based on a combination of histological, clinical, and immunophenotypical criteria. The histological criteria will be based on skin biopsy from the most representative skin area.
* CTCL (Mycosis fungoides) stage IA-IIA (early stage) at the time of screening with either B0 blood involvement with a positive T-cell receptor (TCR) gene rearrangement or B1 blood involvement with positive TCR gene rearrangement. The TNMB system will be used to classify the stage of disease.
* Any number of prior therapies is allowed.
* Patients must have stable disease (SD), partial response (PR) or disease progression (PD) after 3 or more months prior to date of consent of one of the following treatments: Phototherapy \[narrow-band ultraviolet B (nb-UVB) or Psoralen ultraviolet A (PUVA)\] alone or PUVA in combination with topical therapy such as nitrogen mustard, steroids, or bexarotene gel progression of skin disease on long-term maintenance phototherapy.
* A minimum washout period of 14 days prior after previous CTCL therapy before the first day of treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Subjects on a stable dose of a low dose systemic corticosteroid (≤ 20 mg prednisone equivale…
What they're measuring
1
Overall Response Rate
Timeframe: 225 days
Trial details
NCT IDNCT06235281
SponsorH. Lee Moffitt Cancer Center and Research Institute