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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

No Placebo-Only Group

Pivotal Trial

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

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My diagnosis is classical Hodgkin Lymphoma according to WHO standards.

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I have Stage III or IV Hodgkin's lymphoma and haven't received any treatment.

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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:

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I do not have brain or spinal cord disease, including PML.

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I have nerve damage affecting my senses or movement.

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I am HIV positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline until death (approximately up to 4 years)

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

Oropharyngeal pain

Thrombocytopenia

Leukopenia

Upper respiratory tract infection

Dyspepsia

Mucosal inflammation

Bone pain

Depression

Hypotension

Chest pain

Diabetes mellitus

Paraesthesia

Dysgeusia

Hypothyroidism

Urinary tract infection

Alanine aminotransferase increased

Hyperglycaemia

Hyperuricaemia

Neck pain

Pneumonia

Dry skin

Haemorrhoids

Malaise

Nasopharyngitis

Hypercholesterolaemia

Hyperlipidaemia

Benign prostatic hyperplasia

Peripheral motor neuropathy

Pneumonitis

Sepsis

Pneumocystis jirovecii pneumonia

Cellulitis

Acute kidney injury

Clostridium difficile colitis

Deep vein thrombosis

Respiratory failure

Tumour lysis syndrome

Dehydration

Pulmonary embolism

Neutropenic infection

Cutaneous T-cell lymphoma

Device related infection

Influenza

100%

80%

60%

40%

20%

Study treatment Arm

A+CHP

CHOP

A+CHP Subgroup

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

doxorubicin

2005

Completed Phase 3

~9130

brentuximab vedotin

2010