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Mogamulizumab + LD TSEBT for Cutaneous Lymphoma
Phase 2
Recruiting
Led By Youn H Kim, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
If prior allogeneic hematopoietic stem cell transplant (HSCT), then must be free of graft vs host disease (GvHD) and receiving immunosuppressive therapy.
≥ 2 weeks for topical therapy (including topical steroid, retinoid, nitrogen mustard, or imiquimod)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing a combination of two drugs to see if it is effective in treating patients with mycosis fungoides or Sézary syndrome. It will also look at the safety and side effects of the combination.
Who is the study for?
Adults with stages 1B-IV Mycosis Fungoides or Sézary Syndrome who've had at least one prior treatment can join. They should be in decent health, with good organ function and no severe autoimmune diseases, HIV, HTLV-1, or active hepatitis. Pregnant women and those on high-dose steroids are excluded.Check my eligibility
What is being tested?
The trial tests a combination of Mogamulizumab (an immunotherapy drug) and Low-Dose Total Skin Electron Beam Therapy (LD-TSEBT), which is a type of radiation therapy for skin involvement in these conditions to see how effective they are together.See study design
What are the potential side effects?
Possible side effects include skin reactions from LD-TSEBT and immune-related effects from Mogamulizumab such as rash, fatigue, nausea, infusion reactions, and potential increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a stem cell transplant and don't have GvHD or need immunosuppressive therapy.
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I haven't used any skin creams for my condition in the last 2 weeks.
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My liver enzymes are within the required limits, even with my liver condition.
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I have completed skin electron beam therapy more than 12 weeks ago.
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Any side effects from my previous cancer treatments are mild.
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I am able to get out of my bed or chair and move around.
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I am 18 years old or older.
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My cancer is between stages 1B and IV.
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I have had one standard treatment for my condition.
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My kidneys are functioning well, with a creatinine clearance rate over 50 mL/min.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Duration of response (DOR)
Patient reported Quality of Life (QoL)
Progression free survival (PFS)
+2 moreSide effects data
From 2021 Phase 3 trial • 372 Patients • NCT0172880561%
Diarrhoea
42%
Nausea
37%
Fatigue
30%
Thrombocytopenia
30%
Dysgeusia
28%
Blood Creatinine Increased
24%
Decreased Appetite
19%
Alopecia
18%
Constipation
17%
Weight Decreased
16%
Muscle Spasms
15%
Headache
14%
Oedema Peripheral
13%
Asthenia
13%
Hypertension
12%
Vomiting
11%
Abdominal Pain
10%
Dizziness
10%
Platelet Count Decreased
10%
Anaemia
9%
Dry Mouth
9%
Cough
9%
Nasopharyngitis
8%
Chills
8%
Urinary Tract Infection
8%
Paraesthesia
8%
Insomnia
7%
Hyperglycaemia
6%
Pyrexia
6%
Vision Blurred
6%
Abdominal Pain Upper
6%
Dyspepsia
6%
Hypokalaemia
6%
Arthralgia
6%
Dry Eye
6%
Aspartate Aminotransferase Increased
5%
Pain In Extremity
5%
Skin Infection
5%
Back Pain
4%
Myalgia
4%
Dyspnoea
4%
Upper Respiratory Tract Infection
3%
Cellulitis
3%
Sepsis
3%
Pulmonary Embolism
3%
Depression
3%
Oropharyngeal Pain
2%
Folliculitis
1%
Air Embolism
1%
Pelvic Fracture
1%
Left Ventricular Hypertrophy
1%
Subdural Haemorrhage
1%
Mycosis Fungoides
1%
Colon Cancer
1%
Squamous Cell Carcinoma
1%
Febrile Neutropenia
1%
Neutropenia
1%
Intestinal Obstruction
1%
Disease Progression
1%
Facial Pain
1%
General Physical Health Deterioration
1%
Hypothermia
1%
Bronchopneumonia
1%
Diverticulitis
1%
Endocarditis
1%
Gastroenteritis
1%
Influenza
1%
Lower Respiratory Tract Infection
1%
Pneumonia
1%
Septic Shock
1%
Staphylococcal Bacteraemia
1%
Staphylococcal Sepsis
1%
Metabolic Acidosis
1%
Musculoskeletal Chest Pain
1%
Depressed Level of Consciousness
1%
Confusional State
1%
Renal Failure Acute
1%
Renal Impairment
1%
Dermatitis Exfoliative
1%
Pruritis
1%
Skin Disorder
1%
Stomatitis
1%
Oral Candidasis
1%
Drug Eruption
1%
Weight Increased
1%
Cholangitis
1%
Monoparesis
1%
Sepsis Syndrome
1%
Angina Unstable
1%
Anal Fistula
1%
Ileitis
1%
Urinary Retention
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vorinostat
KW-0761
Vorinostat Original Then Crossover to KW-0761
Trial Design
1Treatment groups
Experimental Treatment
Group I: LD TSEBTExperimental Treatment2 Interventions
Mogamulizumab with low dose total skin electron beam therapy. •
LD (12 Gy) TSEBT will be initiated on Cycle 1 Day 2 (± 2 days) of mogamulizumab over 2 to 3 week period per standard of care (SOC), as tolerated. Mogamulizumab (1 mg/kg) will be administered over 60 minutes as follows (per SOC and FDA approved use in MF and SS):
Cycle 1 only: Days1; 8; 15; and 22 (± 2 days)
Cycle 2 and beyond: Day 1 and Day 15 (± 3 days)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mogamulizumab
2016
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,393 Previous Clinical Trials
17,341,162 Total Patients Enrolled
3 Trials studying Sezary Syndrome
2,041 Patients Enrolled for Sezary Syndrome
Youn H Kim, MDPrincipal InvestigatorStanford University
2 Previous Clinical Trials
2,010 Total Patients Enrolled
2 Trials studying Sezary Syndrome
2,010 Patients Enrolled for Sezary Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver is working well.I had a stem cell transplant and don't have GvHD or need immunosuppressive therapy.I haven't used any skin creams for my condition in the last 2 weeks.My liver enzymes are within the required limits, even with my liver condition.I have a history of staph infection but am on stable antibiotics.I have completed skin electron beam therapy more than 12 weeks ago.I am willing to use birth control during and for 3 months after the study.My blood counts are within a healthy range.My kidney function is normal.I have HIV, HTLV-1, or active hepatitis B or C.Any side effects from my previous cancer treatments are mild.It's been over 4 weeks since my last cancer treatment with specific drugs.I am able to get out of my bed or chair and move around.I am 18 years old or older.It has been over 2 weeks since my last phototherapy or local radiation treatment.I am on herpes medication for over 30 days with no recent outbreaks.I am using steroids, but only topical ones or oral prednisone at ≤ 20 mg/day, and have been on a stable dose for at least 4 weeks.My condition is early-stage mycosis fungoides or affects the central nervous system.It's been over 4 weeks since my last monoclonal antibody treatment, except for alemtuzumab which was over 12 weeks ago.I had LD-TSEBT and mogamulizumab over 3 months ago without worsening or stopping due to side effects.My cancer is between stages 1B and IV.I have had one standard treatment for my condition.My kidneys are functioning well, with a creatinine clearance rate over 50 mL/min.
Research Study Groups:
This trial has the following groups:- Group 1: LD TSEBT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we still enrolling participants for this research project?
"Yes, the data on clinicaltrials.gov indicates that this trial is actively recruiting participants. The study was initially posted on 3/30/2020 and most recently edited on 10/19/2022. The study is looking for 30 participants across 1 site."
Answered by AI
How many people are a part of this experiment?
"Yes, this particular study is open for enrollment and seeking patients according to the information on clinicaltrials.gov. The trial was posted on 3/30/2020 and updated as recently as 10/19/2022. They are looking for 30 patients at 1 site specifically."
Answered by AI
What are the long-term risks associated with LD TSEBT?
"LD TSEBT's safety is unproven but there is some clinical data supporting its use, so it received a score of 2."
Answered by AI
Are there other reports of LD TSEBT efficacy?
"At present, there are 10 clinical trials underway for LD TSEBT. Of those, 0 are in Phase 3. Most of the studies for LD TSEBT are based in Bethesda, Maryland, but there are 48 locations running trials for this treatment."
Answered by AI
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