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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Stanford Cancer Center
  Stanford, California, United States Recruiting

Study contacts

• Principal investigator: Youn H Kim, MD — Stanford University
• Study coordinator: Zainab Ahmed
• Email: zahmed01@stanford.edu
• Phone: 650-387-4436

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Treatment for erythrodermic cutaneous T cell lymphoma using photopheresis and mogamulizumab

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• Identifying biomarkers in patients with skin lymphomas.

  This study is trying to find specific markers in the blood and skin of people with skin lymphomas to see if they can help improve treatment options for patients with Mycosis Fungoides and Sézary Syndrome.

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• Collection of blood, urine, and tissue samples for research on skin conditions

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  Recruiting University of Pittsburgh · Pittsburgh, Pennsylvania · NCT00177268

• Mogamulizumab-associated rash in people with mycosis fungoides or Sézary syndrome

  See if a rash that appears while taking mogamulizumab is a drug-related rash and how it links to treatment response in adults with relapsed or refractory mycosis fungoides or Sézary syndrome.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.