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Monoclonal Antibodies

brentuximab vedotin for Hodgkin's Lymphoma

Phase 2
Waitlist Available
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or relapse after discontinuing treatment
Documentation of disease relapse or progression ≥6 months after the last dose of brentuximab vedotin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 35.8 months
Awards & highlights

Study Summary

This trial will determine if brentuximab vedotin is effective and safe when used to re-treat patients whose cancer progressed after they stopped taking the drug.

Eligible Conditions
  • Hodgkin's Lymphoma
  • Peripheral T-Cell Lymphoma
  • Anaplastic Lymphoma

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 35.8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 35.8 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
Number of Participants With Adverse Events
Number of Participants With Laboratory Abnormalities
Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria
Secondary outcome measures
DOR Per Investigator Assessment According to Modified Lugano Response Criteria
Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria
ORR Per BICR According to Lugano Response Criteria
+6 more

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%
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

1Treatment groups
Experimental Treatment
Group I: Brentuximab vedotinExperimental Treatment1 Intervention
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?

Seagen Inc.Lead Sponsor
207 Previous Clinical Trials
69,145 Total Patients Enrolled
Dominic Lai, MDStudy DirectorSeagen Inc.
1 Previous Clinical Trials
990 Total Patients Enrolled

Frequently Asked Questions

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

Are participants being recruited for this experiment at this time?

"That is accurate, the clinical trial in question is still recruiting patients. It was originally posted on October 28th, 2019 and last edited on August 24th, 2022. The study requires 80 participants from 7 different locations."

Answered by AI

Is brentuximab vedotin a danger to patients?

"While there is some evidence that brentuximab vedotin is safe, it only received a score of 2 because this is a phase 2 trial and thus there is no data supporting efficacy."

Answered by AI

Is this a new clinical trial?

"Brentuximab vedotin has been subject to 62 different clinical trials since 2011. These studies, conducted across 31 countries and 627 cities, have involved 79 participants on average. 53 of these trials have completed their Phase 2 drug approval stage."

Answered by AI

What are the standard indications for brentuximab vedotin?

"brentuximab vedotin, while typically used to treat hodgkin disease, can also be an effective intervention for patients with systemic anaplastic large cell lymphoma, peripheral t-cell lymphoma, and those who have not received treatment prior."

Answered by AI

What does the brentuximab vedotin research to date suggest about its potential?

"Brentuximab vedotin was first studied in the year 2011 at University of Texas MD Anderson Cancer Center. Since then there have been 53 completed clinical trials, with 62 more currently underway. Many of these studies are taking place out of New Orleans, Louisiana."

Answered by AI

Does this clinical trial have a presence in multiple states?

"This study is currently recruiting from 7 different hospitals, with Tulane University Hospital and Clinic in New Orleans, University of Maryland in Baltimore, and Memorial Cancer Institute in Pembroke Pines being some of the notable locations."

Answered by AI

How many volunteers are being accepted into this research project?

"In order for this study to be executed, 80 participants that meet the inclusion criteria are required. The sponsor, Seagen Inc., will have different sites where they will administer the trial; a few examples include Tulane University Hospital and Clinic located in New Orleans, Louisiana as well as University of Maryland in Baltimore, Maryland."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma
2019. "A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03947255.
~2 spots leftby Apr 2025
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