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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
Must not have
Concurrent use of other systemic anti-cancer agents or treatments for mycosis fungoides/sezary syndrome, or lymphomatoid papulosis, Grade 2 or greater neuropathy, Severe renal impairment (CrCL <30 mL/min), Moderate or severe hepatic impairment (Child-Pugh B or Child-Pugh C), Women of reproductive potential must have a negative Serum ß human chorionic gonadotropin (ß-HCG) pregnancy test within 1 week of C1D1, Previous use of brentuximab vedotin (for Cohort 1 ONLY), Receiving systemic therapy for another primary malignancy (other than T-cell lymphoma), Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator, Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy (other than T-cell lymphoma) permissible after discussion with the MSK Principal Investigator, For Cohort 2, patients who previously progressed on the standard 1.8mg/kg dose and schedule of brentuximab vedotin are ineligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
overall response

Side effects data

From 2020 Phase 3 trial • 452 Patients • NCT01777152
51%
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%
Cough
17%
Dyspnoea
17%
Headache
16%
Asthenia
14%
Febrile neutropenia
14%
Arthralgia
14%
Dizziness
13%
Stomatitis
13%
Hypokalaemia
13%
Anxiety
12%
Myalgia
12%
Rash
12%
Abdominal pain
10%
Pruritus
10%
Gastrooesophageal reflux disease
10%
Pain in extremity
10%
Abdominal pain upper
9%
Oropharyngeal pain
9%
Thrombocytopenia
8%
Leukopenia
8%
Upper respiratory tract infection
8%
Dyspepsia
7%
Mucosal inflammation
7%
Bone pain
7%
Depression
7%
Hypotension
6%
Chest pain
6%
Diabetes mellitus
6%
Paraesthesia
6%
Dysgeusia
5%
Hypothyroidism
5%
Urinary tract infection
5%
Alanine aminotransferase increased
5%
Hyperglycaemia
5%
Hyperuricaemia
5%
Neck pain
5%
Pneumonia
4%
Dry skin
4%
Haemorrhoids
4%
Malaise
4%
Nasopharyngitis
4%
Hypercholesterolaemia
4%
Hyperlipidaemia
4%
Benign prostatic hyperplasia
4%
Peripheral motor neuropathy
2%
Pneumonitis
2%
Sepsis
1%
Pneumocystis jirovecii pneumonia
1%
Cellulitis
1%
Acute kidney injury
1%
Clostridium difficile colitis
1%
Deep vein thrombosis
1%
Respiratory failure
1%
Tumour lysis syndrome
1%
Dehydration
1%
Pulmonary embolism
1%
Neutropenic infection
1%
Cutaneous T-cell lymphoma
1%
Device related infection
1%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
A+CHP
CHOP
A+CHP Subgroup

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~1900

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,973 Previous Clinical Trials
597,680 Total Patients Enrolled
Seagen Inc.Industry Sponsor
210 Previous Clinical Trials
74,372 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

Brentuximab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03587844 — Phase 2
Lymphomatoid Papulosis Research Study Groups: treated with reduced dose brentuximab vedotin, Patients with LyP, not been previously treated with brentuximab vedotin.
Lymphomatoid Papulosis Clinical Trial 2023: Brentuximab Vedotin Highlights & Side Effects. Trial Name: NCT03587844 — Phase 2
Brentuximab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03587844 — Phase 2
~5 spots leftby Jul 2025
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