Phototherapy and Mogamulizumab in Early Stage MF (PLIGHT)

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 equivalent) for at least 4 weeks prior to day 1 of treatment may continue use. Investigator should attempt to taper the use to the lowest dosage tolerable while on study. Initiation of treatment with systemic corticosteroids or increase in dose while on study is not permitted except to treat an infusion reaction. Subjects may receive intra-articular corticosteroid injections, intraocular corticosteroid drops, inhalation or nasal corticosteroids and replacement doses of systemic corticosteroids as needed.
• •Subjects on a stable dose of topical calcineurin inhibitors, medium or low potency topical corticosteroids for at least 4 weeks prior to the consent date may continue use at the same dose, although the investigator should attempt to taper the use to the lowest dosage tolerable while on study. Initiation of treatment with topical corticosteroids while on study is not permitted except to treat an acute rash.
• •Resolution of all clinically significant toxic effects of prior cancer therapy to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE, v.5.0).
• •Laboratory parameters required to be met prior to the initiation of each cycle: A) Adequate hepatic and kidney function defined as Serum bilirubin less than 1.5x upper limit of normal (ULN), AST and ALT must be less than 2.5x ULN, Serum creatinine \< 1.5x upper limit of normal (ULN) OR calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault formula. B) Adequate hematological function defined as Serum Platelets greater than or equal to 100,000/mm3, Hemoglobin greater than or equal to 9g/dL without transfusion support and Absolute neutrophil count (ANC) greater than or equal to 1,500 cells/μL (greater than or equal to 1,500/mm3).
• •Female of childbearing potential (FCBP) must have a negative pregnancy test within 7 days of receiving study medication.
• •Male subjects and their female partners of childbearing potential must be willing to use an appropriate method of contraception defined as oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide) or practice true abstinence from sexual intercourse (periodic abstinence, e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception) during the study and for 3 months after the last dose.