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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
Have you not received any treatment for your Hodgkin Lymphoma? This could be treatment by mouth or intravenuous injection (IV).
Are you not currently experiencing signs of peripheral neuropathy (burning sensation, pain, weakness, or numbness and tingling [feeling of pins and needles] in your hands or feet)?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 10 years
Awards & highlights

Study Summary

This trial will study brentuximab vedotin for treating Hodgkin lymphoma and peripheral T-cell lymphoma in patients who are unable to have standard chemotherapy.

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You do not have a kidney disease that needs dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 10 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
ORR according to modified Lugano criteria per blinded independent central review (BICR) (Parts E and F)
ORR according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas (Lugano criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D)
Objective response rate (ORR) according to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)
Secondary outcome measures
B symptom resolution rate
Blood concentrations of brentuximab vedotin
Blood concentrations of nivolumab (Part D only)
+11 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%
Headache
17%
Cough
17%
Dyspnoea
16%
Asthenia
14%
Febrile neutropenia
14%
Arthralgia
14%
Dizziness
13%
Stomatitis
13%
Hypokalaemia
13%
Anxiety
12%
Myalgia
12%
Rash
12%
Abdominal pain
10%
Gastrooesophageal reflux disease
10%
Pain in extremity
10%
Abdominal pain upper
10%
Pruritus
9%
Oropharyngeal pain
9%
Thrombocytopenia
8%
Upper respiratory tract infection
8%
Leukopenia
8%
Dyspepsia
7%
Mucosal inflammation
7%
Depression
7%
Hypotension
7%
Bone pain
6%
Chest pain
6%
Diabetes mellitus
6%
Paraesthesia
6%
Dysgeusia
5%
Neck pain
5%
Hypothyroidism
5%
Urinary tract infection
5%
Alanine aminotransferase increased
5%
Hyperuricaemia
5%
Hyperglycaemia
5%
Pneumonia
4%
Nasopharyngitis
4%
Haemorrhoids
4%
Malaise
4%
Hypercholesterolaemia
4%
Hyperlipidaemia
4%
Benign prostatic hyperplasia
4%
Dry skin
4%
Peripheral motor neuropathy
2%
Pneumonitis
2%
Sepsis
1%
Cellulitis
1%
Respiratory failure
1%
Clostridium difficile colitis
1%
Cutaneous T-cell lymphoma
1%
Acute kidney injury
1%
Deep vein thrombosis
1%
Tumour lysis syndrome
1%
Dehydration
1%
Neutropenic infection
1%
Pneumocystis jirovecii pneumonia
1%
Pulmonary embolism
1%
Device related infection
1%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
A+CHP
CHOP
A+CHP Subgroup

Trial Design

6Treatment groups
Experimental Treatment
Group I: Part F: Brentuximab Vedotin in PTCL PatientsExperimental Treatment1 Intervention
Group II: Part E: Brentuximab Vedotin in HL PatientsExperimental Treatment1 Intervention
Group III: Part D: Brentuximab Vedotin + Nivolumab in HL PatientsExperimental Treatment2 Interventions
Group IV: Part C: Brentuximab Vedotin + Bendamustine in HL PatientsExperimental Treatment2 Interventions
Group V: Part B: Brentuximab Vedotin + Dacarbazine in HL PatientsExperimental Treatment2 Interventions
Group VI: Part A: Brentuximab Vedotin in HL PatientsExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dacarbazine
2010
Completed Phase 3
~5030
bendamustine
2012
Completed Phase 4
~1440
nivolumab
2016
Completed Phase 3
~4960
brentuximab vedotin
2010
Completed Phase 3
~1880

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
206 Previous Clinical Trials
69,208 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,405 Total Patients Enrolled
Robert Sims, MDStudy DirectorSeagen Inc.
2 Previous Clinical Trials
307 Total Patients Enrolled

Media Library

Brentuximab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01716806 — Phase 2
Hodgkin's Lymphoma Research Study Groups: Part E: Brentuximab Vedotin in HL Patients, Part D: Brentuximab Vedotin + Nivolumab in HL Patients, Part C: Brentuximab Vedotin + Bendamustine in HL Patients, Part F: Brentuximab Vedotin in PTCL Patients, Part A: Brentuximab Vedotin in HL Patients, Part B: Brentuximab Vedotin + Dacarbazine in HL Patients
Hodgkin's Lymphoma Clinical Trial 2023: Brentuximab Vedotin Highlights & Side Effects. Trial Name: NCT01716806 — Phase 2
Brentuximab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01716806 — Phase 2
Hodgkin's Lymphoma Patient Testimony for trial: Trial Name: NCT01716806 — Phase 2

Frequently Asked Questions

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

What medical conditions are typically addressed through the use of brentuximab vedotin?

"Brentuximab vedotin has proven to be a successful treatment for individuals suffering from unresectable melanoma, squamous cell carcinoma, and pheochromocytomas."

Answered by AI

Are there vacancies in this medical experiment that individuals can fill?

"Affirmative. The clinical trial hosted on the website clinicaltrials.gov is actively recruiting patients, with 180 participants needing to be enrolled at 39 different sites. This research project was first announced on October 31st 2012 and received its last update November 11th 2022."

Answered by AI

What empirical evidence exists for the efficacy of brentuximab vedotin?

"In 2002, brentuximab vedotin was first evaluated at Canberra Hospital. Nowadays, there are 506 complete clinical trials and 860 active ones taking place around the world; a noticable concentration of these studies being conducted in Montreal, Quebec."

Answered by AI

How many locations within this city are participating in the clinical trial?

"Currently, 39 clinical trial sites are participating in the recruitment process. These medical centres are situated in Montreal, Arlington and Fairfax as well as 36 additional locations across North America. To reduce travel-related costs for participants, it is advised to select a clinic within close proximity of your home."

Answered by AI

Is brentuximab vedotin permissible under the guidelines of the Food and Drug Administration?

"Brentuximab vedotin has been evaluated for safety in a Phase 2 trial, thereby earning it an estimated score of 2. However, there is currently no data available to support its efficacy."

Answered by AI

What is the current enrollment quota for this clinical trial?

"This clinical trial necessitates 180 patients that satisfy the eligibility requirements. Potential participants can visit Royal Victoria Hospital, McGill University Health Centre in Montreal, Quebec and Arlington Cancer Center in Arlington, Texas to be considered for this study."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
What site did they apply to?
City of Hope National Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

treatments, 2 the first time I had CHL and combined with holistic I went into remission for 19 months. It returned in July of 2022.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Does the trial include treatment?
PatientReceived 1 prior treatment
Recent research and studies
~11 spots leftby Mar 2025