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Anti-tumor antibiotic

Brentuximab + Chemotherapy for Hodgkin's Lymphoma

Phase 3
Waitlist Available
Research Sponsored by Millennium Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed classical Hodgkin Lymphoma (HL) according to the current World Health Organization (WHO) classification
Treatment-naïve participants with Ann Arbor Stage III or IV HL
Must not have
Cerebral/meningeal disease, including signs and symptoms of progressive multifocalleukoencephalopathy (PML)
Sensory or motor peripheral neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline until death (approximately up to 4 years)
Awards & highlights

Summary

This trial is comparing two standard treatments for advanced Hodgkin lymphoma to see which one leads to better progression-free survival.

Who is the study for?
This trial is for individuals with advanced classical Hodgkin Lymphoma who have measurable disease, are relatively active (ECOG <=2), and haven't started treatment yet. They must be diagnosed at a late stage (III or IV) according to Ann Arbor staging and confirmed by WHO classification.
What is being tested?
The study compares two treatments: A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, dacarbazine) against ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine). It's designed to see which combination better prevents the cancer from progressing without getting worse.
What are the potential side effects?
Possible side effects include reactions related to infusion of brentuximab vedotin like fever and chills; lung issues due to bleomycin; heart problems from doxorubicin; nerve damage from vinblastine; and nausea or liver changes due to dacarbazine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My diagnosis is classical Hodgkin Lymphoma according to WHO standards.
Select...
I have Stage III or IV Hodgkin's lymphoma and haven't received any treatment.
Select...
I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have brain or spinal cord disease, including PML.
Select...
I have nerve damage affecting my senses or movement.
Select...
I am HIV positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline until death (approximately up to 4 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline until death (approximately up to 4 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF)
Secondary study objectives
A+AVD: Number of Participants With Antitherapeutic Antibody (ATA) and Neutralizing Antitherapeutic Antibody (nATA) Positive for Brentuximab Vedotin
Change From Baseline in Patient-Reported Outcome (PRO) Scores by mPFS Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) at EOT
Complete Remission (CR) Per IRF Rate at the End of Frontline Therapy
+9 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%
Cough
17%
Dyspnoea
17%
Headache
16%
Asthenia
14%
Febrile neutropenia
14%
Arthralgia
14%
Dizziness
13%
Stomatitis
13%
Hypokalaemia
13%
Anxiety
12%
Myalgia
12%
Rash
12%
Abdominal pain
10%
Pruritus
10%
Gastrooesophageal reflux disease
10%
Pain in extremity
10%
Abdominal pain upper
9%
Oropharyngeal pain
9%
Thrombocytopenia
8%
Leukopenia
8%
Upper respiratory tract infection
8%
Dyspepsia
7%
Mucosal inflammation
7%
Bone pain
7%
Depression
7%
Hypotension
6%
Chest pain
6%
Diabetes mellitus
6%
Paraesthesia
6%
Dysgeusia
5%
Hypothyroidism
5%
Urinary tract infection
5%
Alanine aminotransferase increased
5%
Hyperglycaemia
5%
Hyperuricaemia
5%
Neck pain
5%
Pneumonia
4%
Haemorrhoids
4%
Dry skin
4%
Malaise
4%
Nasopharyngitis
4%
Hypercholesterolaemia
4%
Hyperlipidaemia
4%
Benign prostatic hyperplasia
4%
Peripheral motor neuropathy
2%
Pneumonitis
2%
Sepsis
1%
Pneumocystis jirovecii pneumonia
1%
Cellulitis
1%
Acute kidney injury
1%
Clostridium difficile colitis
1%
Deep vein thrombosis
1%
Respiratory failure
1%
Tumour lysis syndrome
1%
Dehydration
1%
Pulmonary embolism
1%
Neutropenic infection
1%
Cutaneous T-cell lymphoma
1%
Device related infection
1%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
A+CHP
CHOP
A+CHP Subgroup

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: A + AVDExperimental Treatment4 Interventions
A+AVD consists of brentuximab vedotin (ADCETRIS®) 1.2 milligram per kilogram (mg/kg) plus doxorubicin 25 milligram per square meter (mg/m\^2), vinblastine 6 mg/m\^2, and dacarbazine (DTIC) 375 mg/m\^2.
Group II: ABVDActive Control4 Interventions
ABVD consists of doxorubicin 25 mg/m\^2, bleomycin 10 units per square meter (units/m\^2), vinblastine 6 mg/m\^2, and dacarbazine (DTIC) 375 mg/m\^2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
brentuximab vedotin
2010
Completed Phase 3
~1900
doxorubicin
2005
Completed Phase 3
~9130
vinblastine
2010
Completed Phase 3
~1490
dacarbazine
2008
Completed Phase 3
~6240

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Lead Sponsor
404 Previous Clinical Trials
45,580 Total Patients Enrolled
TakedaLead Sponsor
1,227 Previous Clinical Trials
4,221,171 Total Patients Enrolled
Seagen Inc.Industry Sponsor
210 Previous Clinical Trials
73,386 Total Patients Enrolled

Media Library

Bleomycin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT01712490 — Phase 3
Hodgkin's Lymphoma Research Study Groups: ABVD, A + AVD
Hodgkin's Lymphoma Clinical Trial 2023: Bleomycin Highlights & Side Effects. Trial Name: NCT01712490 — Phase 3
Bleomycin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01712490 — Phase 3
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