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Monoclonal Antibodies

SGN-35 for Skin Lymphomas

Phase 2
Waitlist Available
Led By Ronald P. Rapini, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have a biopsy confirmed diagnosis based on a combination of histological and clinical criteria of CD30+ lymphomatoid papulosis, CD30+ primary cutaneous anaplastic large T-cell lymphoma (pc-ALCL), or CD30+ mycosis fungoides for the phase II trial with no specific limit on positive cells in tumor cells
Patients must have an ECOG performance status of </= 2
Must not have
Dementia or altered mental status
Active systemic or cutaneous infections of grade 3 or higher
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether SGN-35 can help control three different types of skin lymphoma, and whether it is safe to use.

Who is the study for?
Adults with certain skin lymphomas (ALCL, LyP, or MF) that are CD30 positive and have not responded to previous treatments like radiation therapy or chemotherapy. They must be in good enough health for systemic therapy as judged by the doctor, not pregnant, willing to use contraception, and able to follow study procedures.
What is being tested?
The trial is testing SGN-35 (brentuximab vedotin) for its effectiveness in controlling three types of skin lymphomas: ALCL, LyP, and MF. It also aims to evaluate the safety profile of this drug in patients who have these conditions.
What are the potential side effects?
Possible side effects include reactions related to the immune system's response to the drug, potential impact on blood counts leading to increased infection risk or bleeding problems, fatigue from treatment-related stress on the body's systems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My skin cancer diagnosis was confirmed by a biopsy showing CD30+ cells.
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I can take care of myself but might not be able to do heavy physical work.
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I am not pregnant and agree to use birth control during the study.
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My pc-ALCL or MF cancer has worsened after treatment.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have dementia or changes in my mental status.
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I do not have severe infections.
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I am positive for HIV, Hepatitis B, or Hepatitis C.
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My heart condition severely limits my daily activities.
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I am taking a high dose of corticosteroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Response Rate
Secondary study objectives
Time to Progression

Side effects data

From 2018 Phase 3 trial • 131 Patients • NCT01578499
47%
Peripheral sensory neuropathy
36%
Nausea
27%
Diarrhoea
27%
Fatigue
17%
Vomiting
17%
Pruritus
15%
Alopecia
15%
Decreased appetite
14%
Pyrexia
12%
Myalgia
12%
Arthralgia
11%
Asthenia
11%
Oedema peripheral
11%
Rash maculo-papular
11%
Dyspnoea
11%
Pruritus generalised
9%
Paraesthesia
9%
Pain in extremity
9%
Weight decreased
9%
Hypertension
8%
Dysgeusia
8%
Headache
8%
Urticaria
8%
Neutropenia
8%
Hyperglycaemia
6%
Peripheral motor neuropathy
6%
Dizziness
6%
Chills
6%
Upper respiratory tract infection
6%
Hyperuricaemia
6%
Urinary tract infection
6%
Muscle spasms
5%
Anaemia
5%
Constipation
5%
Alanine aminotransferase increased
3%
Skin infection
3%
Insomnia
3%
Cough
3%
Cellulitis
2%
Multiple organ dysfunction syndrome
2%
Neuropathy peripheral
2%
Drug eruption
2%
Cancer pain
2%
Diverticulitis
2%
Sepsis
2%
Impetigo
2%
Sinusitis
2%
Extravasation
2%
General physical health deterioration
2%
Musculoskeletal chest pain
2%
Hypotension
2%
Dry skin
2%
Peripheral swelling
2%
Hypertriglyceridaemia
2%
Lower respiratory tract infection
2%
Fracture
2%
Lymphoma
2%
Neck pain
2%
Hepatocellular injury
2%
Intestinal perforation
2%
Haemolytic uraemic syndrome
2%
Pancreatitis
2%
Pulmonary embolism
2%
Urinary retention
2%
Stress
2%
Aspartate aminotransferase increased
2%
Staphylococcal skin infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brentuximab Vedotin
Methotrexate or Bexarotene

Awards & Highlights

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: SGN-35Experimental Treatment1 Intervention
1.8 mg/kg intravenously Day 1 of 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SGN-35
2006
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Seagen Inc.Industry Sponsor
210 Previous Clinical Trials
74,259 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,268 Total Patients Enrolled
Ronald P. Rapini, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

SGN-35 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01352520 — Phase 2
Anaplastic Large Cell Lymphoma Research Study Groups: SGN-35
Anaplastic Large Cell Lymphoma Clinical Trial 2023: SGN-35 Highlights & Side Effects. Trial Name: NCT01352520 — Phase 2
SGN-35 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01352520 — Phase 2
~6 spots leftby Jan 2026
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