Combining mogamulizumab with low-dose total skin electron beam therapy for treating skin lymphomas

A Phase 2 Single Center, Single Arm, Open Label Mogamulizumab Combined Upfront With Low Dose Total Skin Electron Beam Therapy (LD TSEBT) in Patients With Mycosis Fungoides (MF) and Sézary Syndrome (SS)

This study is testing if combining a new drug called mogamulizumab with a special type of skin radiation therapy can help people with certain skin lymphomas feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Stanford University (Academic / other)
• Drugs / interventions: mogamulizumab, alemtuzumab, radiation, prednisone
• Locations: 1 site (Stanford, California)
• Trial ID: NCT04256018 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of combining mogamulizumab with low-dose total skin electron beam therapy (LD-TSEBT) in patients diagnosed with Mycosis Fungoides (MF) and Sézary Syndrome (SS). The primary objective is to assess the efficacy of this combination therapy, while secondary objectives include evaluating additional clinical benefits, safety, and tolerability. Eligible participants must have specific stages of MF or SS and have undergone at least one prior standard treatment. The study is conducted at Stanford Cancer Center in California.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with stages 1B to IV Mycosis Fungoides or Sézary Syndrome who have received at least one prior treatment.

Not a fit: Patients with earlier stages of MF or SS or those who have not received prior treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from advanced skin lymphomas.

How similar studies have performed: While the combination of therapies is being explored, similar approaches have shown promise in treating other forms of cancer, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

* Stages IB-IV MF or SS

  1. Stages IB-IV MF or SS
  2. At least 1 prior standard-of-care therapy
  3. Prior LD-TSEBT (\> 3 months prior) and prior mogamulizumab is allowed, as long as progressive disease (PD) did not occur while on therapy, and did not discontinue due to toxicities
  4. ≥ 18 years of age
  5. ECOG performance status of 0 to 2
  6. All clinically-significant toxic effects of prior cancer therapy resolved to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE, v 5.0).
  7. MF and a known history of non-complicated staphylococcus colonization/infection is eligible provided that stable doses of prophylactic antibiotics continue.
  8. The following minimum wash-out from previous treatments are required (prior to 1st day of treatment), if applicable.

     • ≥ 2weeks for retinoids, interferons, Vorinostat, romidepsin, pralatrexate, or other systemic anti-cancer/CTCL therapies

     • ≥ 2 weeks for phototherapy, local radiation therapy

     • ≥ 2 weeks for topical therapy (including topical steroid, retinoid, nitrogen mustard, or imiquimod)

     • ≥ 12 weeks for total skin electron beam therapy

     • \> 12 weeks for alemtuzumab

     • Rapidly progressive malignant disease may be enrolled prior to above periods after discussion with the Protocol Director.
  9. Adequate hematologic function

     • Absolute neutrophil count (ANC) ≥ 1,000 cells/μL (≥ 1,000/mm3)

     • Platelets ≥ 75,000 cells/μL (≥ 75,000/mm3).
  10. Adequate hepatic function

      * Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN). Exception: If Gilbert's syndrome; then ≤ 5 times ULN.
      * Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN; or ≤ 5.0 x ULN in the presence of known hepatic involvement by CTCL.
  11. Adequate renal function

      • Calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault formula.
  12. If prior allogeneic hematopoietic stem cell transplant (HSCT), then must be free of graft-vs-host disease (GvHD) and receiving immunosuppressive therapy.
  13. Women of childbearing potential (WOCBP) must have a negative pregnancy test.
  14. WOCBP must agree to use effective contraception during the study and for 3 months after the last dose.
  15. Male participants and their female partners of child bearing potential must be willing to use an appropriate method of contraception during the study and for 3 months after the last dose.

      Exclusion Criteria:

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  1. MF with limited disease (Stage IA) or central nervous system (CNS) disease
  2. Concomitant corticosteroid use. (with the exception that topical steroid and oral prednisone are allowed at ≤ 20 mg/day, if patient has been on a stable dose for at least 2 weeks prior to 1st day of treatment)
  3. Pregnant or breastfeeding
  4. Active autoimmune disease or history deemed by the investigator to be clinically significant
  5. Known human immunodeficiency virus (HIV) positivity; or active hepatitis B or C.
  6. Active herpes simplex or herpes zoster. Those receiving prophylaxis for herpes and who started taking medication at least 30 days prior to the Screening Visit, 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 medication for the duration of the study.

Where this trial is running

Stanford, California

• Stanford Cancer Center — Stanford, California, United States (Recruiting)

Study contacts

• Principal investigator: Youn H Kim, MD — Stanford University
• Study coordinator: Zainab Ahmed

Conditions Sezary Syndrome; Mycosis Fungoides; CTCL