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Monoclonal Antibodies
Brentuximab Vedotin for Cutaneous T-Cell Lymphoma
Phase 2
Recruiting
Led By Niloufer Khan, MD, MS
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will test the safety and efficacy of a lower dose of brentuximab vedotin, compared to the FDA-approved dose.
Who is the study for?
Adults with Mycosis Fungoides or Sezary Syndrome who need treatment can join this trial. It's for those who haven't tried Brentuximab Vedotin, or have used it before without success. People must be generally healthy and not pregnant, with no severe kidney, liver issues, or neuropathy. They should not be on other cancer treatments.Check my eligibility
What is being tested?
The trial is testing a lower dose of Brentuximab Vedotin than the usual FDA-approved amount to see if it's effective and has fewer side effects for skin lymphoma conditions like Mycosis Fungoides and Sezary Syndrome.See study design
What are the potential side effects?
Brentuximab Vedotin may cause symptoms like nerve damage (numbness or tingling), tiredness, infections due to low blood cell counts, digestive problems (nausea or diarrhea), and allergic reactions during infusion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
overall response
Side effects data
From 2020 Phase 3 trial • 452 Patients • NCT0177715251%
Nausea
50%
Peripheral sensory neuropathy
44%
Constipation
42%
Diarrhoea
39%
Neutropenia
39%
Pyrexia
37%
Fatigue
32%
Hypertension
29%
Anaemia
27%
Vomiting
26%
Alopecia
24%
Weight decreased
24%
Decreased appetite
23%
Insomnia
21%
Night sweats
20%
Back pain
18%
Oedema peripheral
17%
Dyspnoea
17%
Headache
17%
Cough
16%
Asthenia
14%
Dizziness
14%
Febrile neutropenia
14%
Arthralgia
13%
Stomatitis
13%
Hypokalaemia
13%
Anxiety
12%
Myalgia
12%
Rash
12%
Abdominal pain
10%
Gastrooesophageal reflux disease
10%
Pruritus
10%
Pain in extremity
10%
Abdominal pain upper
9%
Thrombocytopenia
9%
Oropharyngeal pain
8%
Upper respiratory tract infection
8%
Leukopenia
8%
Dyspepsia
7%
Bone pain
7%
Mucosal inflammation
7%
Depression
7%
Hypotension
6%
Dysgeusia
6%
Chest pain
6%
Diabetes mellitus
6%
Paraesthesia
5%
Neck pain
5%
Hyperglycaemia
5%
Hypothyroidism
5%
Urinary tract infection
5%
Alanine aminotransferase increased
5%
Hyperuricaemia
5%
Pneumonia
4%
Nasopharyngitis
4%
Haemorrhoids
4%
Hypercholesterolaemia
4%
Dry skin
4%
Hyperlipidaemia
4%
Malaise
4%
Benign prostatic hyperplasia
4%
Peripheral motor neuropathy
2%
Pneumonitis
2%
Sepsis
1%
Pulmonary embolism
1%
Cellulitis
1%
Pneumocystis jirovecii pneumonia
1%
Respiratory failure
1%
Neutropenic infection
1%
Clostridium difficile colitis
1%
Cutaneous T-cell lymphoma
1%
Acute kidney injury
1%
Deep vein thrombosis
1%
Tumour lysis syndrome
1%
Dehydration
1%
Device related infection
1%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
A+CHP
CHOP
A+CHP Subgroup
Trial Design
3Treatment groups
Experimental Treatment
Group I: treated with reduced dose brentuximab vedotinExperimental Treatment1 Intervention
Patients with MF/SS who were previously treated with brentuximab vedotin. Up to 10 patients will be enrolled onto this cohort. Following identification of a promising dose after the completion of the full Cohort 1 Simon two stage design, enrollment will initiate onto cohort 2 at the dose found to be promising in cohort 1. For MF patients: Treatment delays lasting longer than 8 weeks for toxicity will result in removal from study. The 0.9mg/kg dose did not meet the primary endpoint for response, therefore 1.2 mg/kg has been chosen as the dose for Cohort 2. As of October 2020, enrollment on our exploratory Cohort 2 has opened at the 1.2 mg/kg dose.
Group II: not been previously treated with brentuximab vedotin.Experimental Treatment1 Intervention
Patients with MF/SS who have not been previously treated with brentuximab vedotin. For MF patients: Treatment delays lasting longer than 8 weeks for toxicity will result in removal from study. As of October 2020, the Simon two stage design for Cohort 1 has restarted at the 1.2 mg/kg dose.
Group III: Patients with LyPExperimental Treatment1 Intervention
Patients with LyP patients with lymphomatoid papulosis will receive brentuximab vedotin 0.9 mg/kg as an intravenous infusion over 30 minutes every three weeks. Cohort 3 will enroll patients concurrently with Cohort 1. Treatment may be held if felt to be in patient's best interest (for example: for toxicity or no active disease). Treatment can be reinitiated after discussion with MSK PI as long as the study is still open and patient has not received alternate systemic therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
brentuximab vedotin
2010
Completed Phase 3
~1880
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,831 Total Patients Enrolled
Seagen Inc.Industry Sponsor
208 Previous Clinical Trials
74,170 Total Patients Enrolled
2 Trials studying Lymphomatoid Papulosis
119 Patients Enrolled for Lymphomatoid Papulosis
Niloufer Khan, MD, MSPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Patients with LyP
- Group 2: treated with reduced dose brentuximab vedotin
- Group 3: not been previously treated with brentuximab vedotin.
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.
Is this research study open to new participants?
"Yes, the study is still open to recruitment according to information available on clinicaltrials.gov. This research was originally posted on July 3rd, 2018 and updated November 3rd, 2022. The trial will have 58 patients at 8 different sites."
Answered by AI
Does the brentuximab vedotin drug have FDA approval?
"Brentuximab vedotin's Phase 2 status means that, while there is some evidence of its safety, there is no data currently supporting its efficacy."
Answered by AI
What other scientific investigations have included brentuximab vedotin?
"62 separate studies are being conducted to study brentuximab vedotin. Out of those, 6 have progressed to Phase 3 clinical trials. Most of the research for this medication is happening in Montvale, New jersey; however, 1851 total facilities worldwide are running some form of investigation into brentuximab vedotin."
Answered by AI
What are the primary benefits of brentuximab vedotin?
"Brentuximab vedotin is used to treat hodgkin disease, as well as other conditions including systemic anaplastic large cell lymphoma and previously untreated peripheral t-cell lymphoma."
Answered by AI
Do different hospitals in the US have this same experiment underway?
"To limit the burden of travel on participants, this trial is running at 8 sites that are relatively close together. The locations include Harrison, Middletown, and Basking Ridge as well as other cities."
Answered by AI
Is this a new clinical trial?
"Brentuximab vedotin has been under research since 2011. The first trial, which involved 79 patients and was sponsored by Seagen Inc., occurred that same year. Brentuximab vedotin received Phase 2 drug approval after the initial study yielded positive results. As of now, there are 62 active studies being conducted in 31 countries and 627 cities worldwide."
Answered by AI
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