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Mycosis FungoidesEarly Phase 1PLIGHTNCT06235281

Phototherapy and Mogamulizumab in Early Stage MF (PLIGHT)

A Early Phase 1 study testing Mogamulizumab-Kpkc and Phototherapy in people with Mycosis Fungoides, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This is an open label, single arm, single-center, pilot study of concurrent phototherapy and POTELIGEO (mogamulizumab-kpkc) in early-stage mycosis fungoides. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mycosis Fungoides
What is being tested?
Mogamulizumab-Kpkc and Phototherapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
18 Jan 2024to 1 Sep 2029
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).
  • Subjects previously treated with POTELIGEO (mogamulizumab-kpkc) are eligible if they achieved complete response on mogamulizumab and the last treatment was over 1 year ago.
  • 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.

Who cannot join

  • Current evidence of large cell transformation (LCT) on biopsy. Subjects with clinical features suggestive of LCT must have a biopsy performed within 4 months prior to Cycle
  • 1 Day 1 to rule out transformed disease. Subjects with a history of LCT but without current aggressive disease and no current evidence of LCT on pathology in skin or lymph nodes would be eligible.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator (including but not limited to severe dermatitis). Any active infection requiring systemic therapy, including human immunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV), Hepatitis B, and/or Hepatitis C.
  • Active herpes simplex or herpes zoster. Subjects on prophylaxis for herpes who started taking medication at least 30 days prior to consent, and have no active signs of active infection, and whose last active infection was more than 6 months ago, may enter the study, and should continue to take the prescribed prophylactic medication for the duration of the study.
  • Any major surgery or radiation therapy within four weeks.
  • Diagnosed with a malignancy in the past 2 years except nonmelanoma skin cancers, melanoma in situ, localized cancer of the prostate with current prostate-specific antigen of less than 0.1 ng/mL, treated thyroid cancer, cervical carcinoma in situ or ductal/lobular carcinoma in situ of the breast with in the past 2 years may enroll as long as there is no current evidence of active disease.
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  • If pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with consent through 30 after the last dose of trial treatment.
  • Significant uncontrolled intercurrent illness including, but not limited to: uncontrolled infection requiring systemic antibiotics; clinically significant cardiac disease (class III or IV of the New York Heart Association [NYHA] classification); unstable angina pectoris; angioplasty, stenting, or myocardial infarction within 6 months; uncontrolled hypertension (systolic blood pressure (BP) greater than 160 mm Hg or diastolic BP greater than 100 mm Hg, found on 2 consecutive measurements separated by a 1-week period) despite 2 anti-hypertensive medications; clinically significant cardiac arrhythmia or uncontrolled diabetes.
  • Known active autoimmune disease will be excluded. (For example, Graves' disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn's disease).
  • Documented prior hypersensitivity (i.e., allergic reaction) to POTELIGEO (mogamulizumab-kpkc) with a severity of Grade 2 or higher.
  • Experienced allergic (does not include a grade 1-2 infusion-related) reactions to monoclonal antibodies or other therapeutic proteins.
  • History of allogeneic transplant or autologous hematopoietic stem cell transplant.
  • Subjects on any immunomodulatory drug for concomitant or intercurrent conditions other than T-cell lymphoma or who have received any of these agents within 4 weeks of treatment, including but not limited to the following, will be excluded: low dose or oral methotrexate; azathioprine; iv immunoglobulin; low dose or oral cyclophosphamide; cyclosporine; mycophenolate; infliximab; etanercept; leflunomide; adalimumab; lenalidomide; abatacept; rituximab; anakinra; interferon-β; IL-2 and natalizumab.
  • Currently taking potential photosensitizing medications.
  • Known or symptoms of photosensitivity disorders, including porphyria, lupus erythematosus, xeroderma pigmentosum, vitiligo, etc.
  • History of phototoxic eruptions, photoallergic eruptions or PMLE (polymorphous light eruption).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Single-Arm, Open-Label, Pilot Study of Concurrent Phototherapy and POTELIGEO (Mogamulizumab-kpkc) in Early Stage Mycosis Fungoides (PLIGHT)

This is an open label, single arm, single-center, pilot study of concurrent phototherapy and POTELIGEO (mogamulizumab-kpkc) in early-stage mycosis fungoides.

Being tested
Mogamulizumab-Kpkc, Phototherapy
Keywords
Early Stage Mycosis Fungoides
Medical subject headings
Mycosis Fungoides

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mogamulizumab-KpkcDrug

    Also called POTELIGEO

    Participants will receive 8 total cycles of Mogamulizumab-Kpkc over approximately 224 days.

  • PhototherapyDevice

    Also called nb-UVB

    Participants will begin receiving Phototherapy on day 56 and will continue until day 224. Participants with Complete response (CR) or Partial response (PR) to therapy at day 224 will remain on phototherapy maintenance.

Study groups in NCT06235281
Study groupRoleWhat they receive
POTELIGEO & Phototherapy combination therapyExperimentalPOTELIGEO (mogamulizumab-kpkc) will be given according to FDA approved dose and scheduled for 8 cycles. After 2 cycles of POTELIGEO, all subjects will start phototherapy as combination therapy.
Receives: Drug: Mogamulizumab-Kpkc; Device: Phototherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    Overall Response Rate (ORR) is defined as the total proportion of patients in Complete Response (CR) + Partial Response (PR) and will be evaluated at days 57 and 225.

    Measured: 225 days

Secondary outcomes (5)

  1. Time to response in skin

    Date of initiation of treatment to date when criteria for response (PR or CR) first met.

    Measured: 225 days

  2. Duration of skin response for responding subjects

    Date when criteria for response (CR or PR) first met until date response first lost; date of loss of response = date when first meets criteria for PD or relapse.

    Measured: 5 years

  3. Time to treatment failure

    Date of initiation of treatment until abandonment of therapy or the addition of another mycosis fungoides specific therapy.

    Measured: 5 years

  4. CD4+CD26- and CD4+CD7 Change

    This will be defined as the Change from baseline and longitudinally during the study in absolute numbers of CD4+CD26- and CD4+CD7- in PBC by 10 color flow cytometry.

    Measured: 5 years

  5. Pruritus Change

    This will be defined as the change from baseline and longitudinally during the study in Pruritus, by quantification of pruritus severity by a visual analog scale.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2024
  2. Study start18 Jan 2024
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Sep 2029 (estimated)

Why it stopped: Slow Accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06235281
Sponsor's protocol ID
MCC-21143
Acronym
PLIGHT
Status last verified
Feb 2026
First submitted
23 Jan 2024
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Mogamulizumab-Kpkc and Phototherapy in people with Mycosis Fungoides, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: 225 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06235281.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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