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Monoclonal Antibodies

Brentuximab Vedotin for Hodgkin's Lymphoma

Phase 2

Waitlist Available

Led By Allison Moskowitz, MD

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

Histologic diagnosis of cd30 positive classical Hodgkin's lymphoma

Primary refractory or relapsed disease proven by biopsy or fine needle aspiration (cytology) of an involved site. Pathology must be reviewed at MSKCC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will study whether 2 cycles of SGN-35 can be used instead of ICE prior to autologous stem cell transplant (ASCT) for relapsed and refractory HL.

Who is the study for?

This trial is for patients aged 12-72 with CD30 positive classical Hodgkin's lymphoma that has returned or didn't respond to initial treatment. They must have adequate organ function, no severe peripheral neuropathy, not be pregnant or breastfeeding, and HIV negative. Those who've had more than one prior treatment or are hepatitis B positive cannot join.Check my eligibility

What is being tested?

The study tests if Brentuximab vedotin (SGN-35) can replace ICE chemotherapy before a stem cell transplant in relapsed/refractory Hodgkin's lymphoma. SGN-35 targets cancer cells directly and may cause fewer side effects than ICE. PET scans will help decide if additional chemo is needed before the transplant.See study design

What are the potential side effects?

Brentuximab vedotin (SGN-35) might cause less severe side effects compared to standard ICE chemotherapy; however, it can still lead to symptoms like fatigue, infusion reactions, blood count changes, and potential nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphoma is confirmed to be CD30 positive.

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My cancer came back or didn't respond to treatment, confirmed by a biopsy.

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My condition worsened or didn't improve after treatment with doxorubicin or nitrogen mustard.

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My cancer shows up on special scans and has a visible tumor at least 1.5 cm big.

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My heart pumps well, with an ejection fraction over 45% after my last chemotherapy.

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My lung function test shows I can breathe well after my last chemotherapy.

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My kidney function is normal, based on my creatinine levels or clearance.

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My total bilirubin level is below 2.0 mg/dl, and I don't have Gilbert's disease.

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I am between 12 and 72 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

rate of FDG-PET/CT normalization

Secondary outcome measures

Toxicity

overall response rate

Trial Design

2Treatment groups

Experimental Treatment

Group I: FDG-PET normalizationExperimental Treatment1 Intervention

Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations.

Group II: FDG-PET abnormalExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

brentuximab vedotin (SGN-35)

2012

Completed Phase 2

~50

Brentuximab Vedotin (SGN-35)

2012

Completed Phase 2

~50

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hôpitaux Universitaires Henri Mondor, FranceUNKNOWN

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,576 Total Patients Enrolled

Seagen Inc.Industry Sponsor

207 Previous Clinical Trials

69,111 Total Patients Enrolled

Frequently Asked Questions

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

How can I get involved in this research project?

"To participate in this research, individuals must have hodgkin disease and be between 12 to 72 years old. So far, 46 people have been recruited."

Answered by AI

What are the official guidelines from the FDA in regards to Brentuximab Vedotin (SGN-35)?

"Brentuximab Vedotin (SGN-35) is a medication that, while still in Phase 2 trials, has received a score of 2 for safety. This means that there is some evidence to support its safety but not yet any efficacy."

Answered by AI

What other steps have been taken to research Brentuximab Vedotin (SGN-35)?

"Brentuximab Vedotin (SGN-35) is being trialed in 62 studies, 6 of which are Phase 3 clinical trials. The primary research and development location for this medication is Montvale, New jersey; though, there are 1,851 trial sites across the globe."

Answered by AI

Do we have any previous research to compare this trial against?

"Brentuximab Vedotin (SGN-35) is being trialed in 62 live studies, taking place in 31 countries across 627 cities. The first study began in 2011 and was sponsored by Seagen Inc. In this Phase 2 drug approval stage trial, 79 participants were involved and it completed successfully. Since then, 53 more studies have been completed."

Answered by AI

What are the primary indications for Brentuximab Vedotin (SGN-35)?

"Brentuximab Vedotin (SGN-35) is most often used to treat hodgkin disease, but it can also be an effective treatment for other blood cancers like systemic anaplastic large cell lymphoma and peripheral t-cell lymphoma."

Answered by AI

Is this research project enrolling people who are 35 years old or younger?

"This study is specifically looking for patients between the ages of 12 and 72. There are 321 clinical trials currently underway for people under 18 years old and 1659 studies recruiting patients that are over 65."

Answered by AI

Are researchers looking for more participants in this study?

"As of right now, this clinical trial is not looking for new patients. The study was first posted on January 5th, 2012 and was edited most recently on June 13th, 20212. However, there are 1770 other studies that are currently seeking patients with hodgkin disease. Additionally, 62 studies involving Brentuximab Vedotin (SGN-35) are also admitting participants."

Answered by AI

How many patients are participating in this trial?

"At the moment, this study is not looking for new patients. The listing was first posted on January 5th 2012 and was edited most recently on June 13th 2020. If you are interested in other trials, there are 1,770 studies actively recruiting patients with hodgkin disease and 62 Brentuximab Vedotin (SGN-35) trials also seeking participants."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Pet-adapted Sequential Salvage Therapy with Brentuximab Vedotin Followed by Augmented Ifosamide, Carboplatin, and Etoposide for Patients with Relapsed and Refractory Hodgkin's Lymphoma: A Non-randomised, Open-label, Single-centre, Phase 2 Study

Moskowitz, Alison J, Heiko Schöder, Joachim Yahalom, Susan J McCall, Stephanie Y Fox, John Gerecitano, Ravinder Grewal, et al.. 2015. “Pet-adapted Sequential Salvage Therapy with Brentuximab Vedotin Followed by Augmented Ifosamide, Carboplatin, and Etoposide for Patients with Relapsed and Refractory Hodgkin's Lymphoma: A Non-randomised, Open-label, Single-centre, Phase 2 Study”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(15)70013-6.

clinicaltrials.govStudy

Brentuximab Vedotin (SGN-35) in Transplant Eligible Patients With Relapsed or Refractory Hodgkin Lymphoma

2012. "Brentuximab Vedotin (SGN-35) in Transplant Eligible Patients With Relapsed or Refractory Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01508312.