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Monoclonal Antibodies

SGN-35 for Skin Lymphomas

Q: How many individuals are being given the opportunity to participate in this research project?

This study is not recruiting at this time, according to the latest update on September 7th, 2022. However, there are 2806 trials for <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a> and 62 SGN-35 trials that are still looking for patients.

Q: To your knowledge, have there been other research studies that used SGN-35?

As of right now, there are 62 ongoing clinical trials for SGN-35. Of these 62 trials, 6 are in Phase 3. The majority of the tests taking place are located in Montvale, <a href="https://www.withpower.com/clinical-trials/new-jersey">New jersey</a>; however, there are 1,851 total locations running studies related to SGN-35.

Q: What conditions does SGN-35 usually treat?

SGN-35 can be used to treat hodgkin disease, systemic anaplastic large cell <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>, and peripheral t-cell lymphoma.

Q: Is this clinical trial novel in any way?

As of now, 62 separate clinical trials for SGN-35 are ongoing in 627 cities and 31 nations. The first official trial began back in 2011 and was completed after 79 participants went through Phase 2 of the study sponsored by Seagen Inc. In the years since 2011, 53 more trials have been successfully conducted.

Q: Are we still enrolling patients in this experiment?

Right now, this clinical trial isn't looking for new patients. However, it's worth noting that the study was first posted on 6/1/2011 and most recently edited on 9/7/2022. There are presently 2806 clinical trials actively admitting patients with <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a> and 62 studies for SGN-35 actively enrolling patients.

Q: Could you please highlight any dangers associated with SGN-35?

While there is some evidence to support the safety of SGN-35, as this is only a Phase 2 trial, Power rates it with a 2.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My skin cancer diagnosis was confirmed by a biopsy showing CD30+ cells.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

I am not pregnant and agree to use birth control during the study.

Select...

My pc-ALCL or MF cancer has worsened after treatment.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response Rate

Secondary outcome measures

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

Paraesthesia

Pain in extremity

Weight decreased

Hypertension

Dysgeusia

Headache

Urticaria

Neutropenia

Hyperglycaemia

Peripheral motor neuropathy

Dizziness

Chills

Upper respiratory tract infection

Hyperuricaemia

Urinary tract infection

Muscle spasms

Anaemia

Constipation

Alanine aminotransferase increased

Skin infection

Insomnia

Cough

Cellulitis

Drug eruption

Cancer pain

Diverticulitis

Sepsis

Impetigo

Sinusitis

Extravasation

General physical health deterioration

Multiple organ dysfunction syndrome

Neuropathy peripheral

Musculoskeletal chest pain

Hypotension

Dry skin

Peripheral swelling

Hypertriglyceridaemia

Lower respiratory tract infection

Fracture

Lymphoma

Neck pain

Hepatocellular injury

Intestinal perforation

Haemolytic uraemic syndrome

Pancreatitis

Pulmonary embolism

Urinary retention

Stress

Aspartate aminotransferase increased

Staphylococcal skin infection

100%

80%

60%

40%

20%

Study treatment Arm

Brentuximab Vedotin

Methotrexate or Bexarotene

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seagen Inc.Industry Sponsor

207 Previous Clinical Trials

69,078 Total Patients Enrolled

67 Trials studying Lymphoma

7,477 Patients Enrolled for Lymphoma

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,702 Total Patients Enrolled

253 Trials studying Lymphoma

32,481 Patients Enrolled for Lymphoma

Ronald P. Rapini, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

SGN-35 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01352520 — Phase 2

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being given the opportunity to participate in this research project?

"This study is not recruiting at this time, according to the latest update on September 7th, 2022. However, there are 2806 trials for lymphoma and 62 SGN-35 trials that are still looking for patients."

Answered by AI

To your knowledge, have there been other research studies that used SGN-35?

"As of right now, there are 62 ongoing clinical trials for SGN-35. Of these 62 trials, 6 are in Phase 3. The majority of the tests taking place are located in Montvale, New jersey; however, there are 1,851 total locations running studies related to SGN-35."

Answered by AI

What conditions does SGN-35 usually treat?

"SGN-35 can be used to treat hodgkin disease, systemic anaplastic large cell lymphoma, and peripheral t-cell lymphoma."

Answered by AI

Is this clinical trial novel in any way?

"As of now, 62 separate clinical trials for SGN-35 are ongoing in 627 cities and 31 nations. The first official trial began back in 2011 and was completed after 79 participants went through Phase 2 of the study sponsored by Seagen Inc. In the years since 2011, 53 more trials have been successfully conducted."

Answered by AI

Are we still enrolling patients in this experiment?

"Right now, this clinical trial isn't looking for new patients. However, it's worth noting that the study was first posted on 6/1/2011 and most recently edited on 9/7/2022. There are presently 2806 clinical trials actively admitting patients with lymphoma and 62 studies for SGN-35 actively enrolling patients."

Answered by AI