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New treatment option for Sezary Syndrome
Official title Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome
ClinicalTrials.gov ID: NCT04256018
What this study is testing
What is Mogamulizumab?
Mogamulizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sezary syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine the efficacy of the combination of LD-TSEBT and mogamulizumab in patients with MF and SS. And to evaluate the secondary measures of clinical benefit of the combination therapy and to evaluate the safety and tolerability of the combination in patients with MF and SS.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Stages IB-IV MF or SS
- Stages IB-IV MF or SS
- At least 1 prior standard-of-care therapy
- 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...
- ≥ 18 years of age
You likely can't join if
- MF with limited disease (Stage IA) or central nervous system (CNS) disease
- Concomitant corticosteroid use. (with the exception that topical steroid and oral prednisone are allowed at ≤ 20 mg/day, if patient has been on a...
- Pregnant or breastfeeding
- Active autoimmune disease or history deemed by the investigator to be clinically significant
- Known human immunodeficiency virus (HIV) positivity; or active hepatitis B or C.
- Active herpes simplex or herpes zoster. Those receiving prophylaxis for herpes and who started taking medication at least 30 days prior to the...
See the full eligibility criteria
- Stages IB-IV MF or SS
- Stages IB-IV MF or SS
- At least 1 prior standard-of-care therapy
- 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
- ≥ 18 years of age
- ECOG performance status of 0 to 2
- 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).
- MF and a known history of non-complicated staphylococcus colonization/infection is eligible provided that stable doses of prophylactic antibiotics continue.
- 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.
- Adequate hematologic function
- Absolute neutrophil count (ANC) ≥ 1,000 cells/μL (≥ 1,000/mm3)
- Platelets ≥ 75,000 cells/μL (≥ 75,000/mm3).
- 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.
- Adequate renal function
- Calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault formula.
- If prior allogeneic hematopoietic stem cell transplant (HSCT), then must be free of graft-vs-host disease (GvHD) and receiving immunosuppressive therapy.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test.
- WOCBP must agree to use effective contraception during the study and for 3 months after the last dose.
- 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.
- MF with limited disease (Stage IA) or central nervous system (CNS) disease
- 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)
- Pregnant or breastfeeding
- Active autoimmune disease or history deemed by the investigator to be clinically significant
- Known human immunodeficiency virus (HIV) positivity; or active hepatitis B or C.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.