LD TSEBT for Sezary Syndrome
Stanford Cancer Center, Stanford, CA
Targeting 2 different conditionsLD TSEBT +1 morePhase 2RecruitingLed by Youn H Kim, MDResearch Sponsored by Stanford UniversityEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stages 1B IV MF or SS
1 prior standard of care therapy
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow ups3 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
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.
Eligible Conditions
- Sezary Syndrome
- Mycosis Fungoides
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have advanced-stage mycosis fungoides or Sézary syndrome.
Select...
You have already received one type of standard treatment for your condition.
Select...
You have received phototherapy or local radiation therapy within the past two weeks.
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You have stopped taking retinoids, interferons, Vorinostat, romidepsin, pralatrexate, or other cancer treatments for at least 4 weeks.
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You have received total skin electron beam therapy for at least 12 weeks.
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You may have received LD-TSEBT or mogamulizumab treatments in the past, as long as your disease did not get worse while on these therapies and you did not stop them because of side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow ups ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow ups ~ 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 • NCT0172880532%
Infusion Related Reaction
24%
Diarrhoea
24%
Fatigue
24%
Drug Eruption
16%
Nausea
15%
Oedema Peripheral
14%
Pyrexia
13%
Headache
13%
Constipation
11%
Anaemia
11%
Upper Respiratory Tract Infection
11%
Thrombocytopenia
10%
Cough
9%
Skin Infection
9%
Back Pain
9%
Insomnia
9%
Hypertension
8%
Folliculitis
8%
Weight Increased
8%
Decreased Appetite
8%
Hyperglycaemia
7%
Vomiting
7%
Urinary Tract Infection
7%
Arthralgia
7%
Myalgia
7%
Pain In Extremity
7%
Nasopharyngitis
7%
Chills
7%
Dizziness
7%
Alopecia
6%
Weight Decreased
6%
Hypokalaemia
6%
Oropharyngeal Pain
5%
Oral Candidasis
5%
Depression
5%
Dyspnoea
5%
Stomatitis
5%
Muscle Spasms
5%
Asthenia
4%
Vision Blurred
4%
Aspartate Aminotransferase Increased
4%
Abdominal Pain
4%
Dry Eye
4%
Dysgeusia
3%
Paraesthesia
3%
Cellulitis
3%
Blood Creatinine Increased
2%
Disease Progression
2%
Pneumonia
2%
Hypercalcaemia
2%
Dry Mouth
2%
Platelet Count Decreased
2%
Sepsis
1%
Cardiac Failure
1%
Myocarditis
1%
Supraventricular Tachycardia
1%
Retinal Vein Occlusion
1%
General Physical Health Deterioration
1%
Hypothermia
1%
Oedema
1%
Hepatocellular Injury
1%
Contrast Media Allergy
1%
Drug Hypersensitivity
1%
Hypersensitivity
1%
Abscess Limb
1%
Arthritis Bacterial
1%
Atypical Pneumonia
1%
Bacteraemia
1%
Bronchitis
1%
Cytomegalovirus Infection
1%
Herpes Simplex
1%
Influenza
1%
Lower Respiratory Tract Infection
1%
Meningitis
1%
Osteomyelitis
1%
Periorbital Cellulitis
1%
Pneumocystis Jiroveci Pneumonia
1%
Pneumonia Influenzal
1%
Pneumonia Legionella
1%
Pneumonia Pneumococcal
1%
Respiratory Tract Infection
1%
Staphylococcal Abscess
1%
Staphylococcal Bacteraemia
1%
Staphylococcal Infection
1%
Staphylococcal Sepsis
1%
Subdural Haematoma
1%
Vascular Access Complication
1%
Alanine Aminotransferase Increased
1%
Blood Alkaline Phospatase Increased
1%
Dehydration
1%
Gout
1%
Hypoalbuminaemia
1%
Myositis
1%
Adenocarcinoma
1%
Malignant Melanoma
1%
Malignant Pleural Effusion
1%
Ovarian Cancer
1%
Haemorrhage Intracranial
1%
Mental Status Changes
1%
Haematuria
1%
Renal Failure
1%
Renal Failure Acute
1%
Acute Respiratory Distress Syndrome
1%
Bronchitis Chronic
1%
Chronic Obstructive Pulmonary Disease
1%
Dyspnoea Exertional
1%
Haemoptysis
1%
Interstitial Lung Disease
1%
Respiratory Failure
1%
Dermatitis Exfoliative
1%
Photosensitivity Reaction
1%
Social Stay Hospitalization
1%
Cardiac Pacemaker Replacement
1%
Embolism
1%
Peripheral Arterial Occlusive Disease
1%
Phlebitis
1%
Abdominal Pain Upper
1%
Dyspepsia
1%
Autoimmune Hepatitis
1%
Wound Infection
1%
Fall
1%
Muscular Weakness
1%
Polymyositis
1%
Basal Cell Carcinoma
1%
Miller Fisher Syndrome
1%
Motor Dysfunction
1%
Acute Myocardial Infarction
1%
Lens Dislocation
1%
Gastric Haemorrhage
1%
Superinfection
1%
Laceration
1%
Pleural Effusion
1%
Pneumonitis
1%
Hepatitis Acute
1%
Septic Embolus
100%
80%
60%
40%
20%
0%
Study treatment Arm
KW-0761
Vorinostat
Vorinostat Original Then Crossover to KW-0761
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
FDA approved
Find a site
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,258 Previous Clinical Trials
17,273,730 Total Patients Enrolled
3 Trials studying Sezary Syndrome
2,041 Patients Enrolled for Sezary Syndrome
Youn H Kim, MDPrincipal Investigator
Stanford University2 Previous Clinical Trials
2,010 Total Patients Enrolled
2 Trials studying Sezary Syndrome
2,010 Patients Enrolled for Sezary Syndrome
Media Library
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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