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Anti-tumor antibiotic

Brentuximab + Chemotherapy for Hodgkin's Lymphoma

Q: Is this clinical trial limited to only North America?

There are a total of 90 sites where this study is enrolling patients, with locations in cities such as Fresno, Albuquerque and Chattanooga. To cut down on travel time and stress, it would be ideal to select the location nearest you.

Q: What are brentuximab vedotin's most common applications?

brentuximab vedotin, which is normally used to treat <a href="https://www.withpower.com/clinical-trials/acute-lymphoblastic-leukemia">acute lymphoblastic leukemia</a> (<a href="https://www.withpower.com/clinical-trials/all">all</a>), can also be given as a form of treatment to patients with advanced <a href="https://www.withpower.com/clinical-trials/endometrial-cancer">endometrial cancer</a>, primary cutaneous anaplastic large cell <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a> and classical hodgkin's lymphoma.

Q: How many individuals are acting as test subjects in this experiment?

Unfortunately, this study is not currently looking for new patients. Although it was last updated recently on February 4th, 2022, the trial was first posted over 9 years ago on November 9th, 2012. There are other trials though! If you search for <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a> clinical trials, there are 1764 that are actively enrolling participants right now. For brentuximab vedotin specifically, 453 trials are admitting patients.

Q: Are there other drug trials that have used brentuximab vedotin?

Brentuximab vedotin was first studied in 1997 and has been the subject of 810 completed clinical trials since. As of now, 453 more studies are actively recruiting patients. A large number these brentuximab vedotin trials are based out of Fresno, <a href="https://www.withpower.com/clinical-trials/california">California</a>.

Q: Are there any dangers associated with brentuximab vedotin therapy?

Brentuximab vedotin's safety is estimated to be a 3. This score comes from the fact that this treatment is in Phase 3 trials, so while there isn't extensive data on its efficacy, there are multiple rounds of data supporting its safety.

Q: Are currently enrolling individuals in this clinical trial?

Recruitment for this study has concluded. It was originally posted on November 9th, 2012 and last edited on February 4th, 2022. If you are interested in other trials, there are 1764 active studies related to <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a> and 453 involving brentuximab vedotin that are recruiting patients.

Q: Does this experiment differ significantly from others like it?

brentuximab vedotin has been under clinical observation since 1997. The first set of trials were sponsored by Alfacell and conducted in the same year. These initial 300 cases allowed for brentuximab vedotin to be approved as a Phase 3 drug. In total, there are 453 active studies being done on brentuximab vedotin across 2039 cities in 67 countries.

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF)

Secondary outcome measures

A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC and TAb

A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin MMAE

A+AVD: Cmax: Maximum Observed Plasma Concentration for Brentuximab Vedotin Monomethyl Auristatin E (MMAE)

+15 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

Thrombocytopenia

Oropharyngeal pain

Upper respiratory tract infection

Leukopenia

Dyspepsia

Bone pain

Mucosal inflammation

Depression

Hypotension

Dysgeusia

Chest pain

Diabetes mellitus

Paraesthesia

Neck pain

Hyperglycaemia

Hypothyroidism

Urinary tract infection

Alanine aminotransferase increased

Hyperuricaemia

Pneumonia

Nasopharyngitis

Haemorrhoids

Hypercholesterolaemia

Dry skin

Hyperlipidaemia

Malaise

Benign prostatic hyperplasia

Peripheral motor neuropathy

Pneumonitis

Sepsis

Pulmonary embolism

Cellulitis

Pneumocystis jirovecii pneumonia

Respiratory failure

Neutropenic infection

Clostridium difficile colitis

Cutaneous T-cell lymphoma

Acute kidney injury

Deep vein thrombosis

Tumour lysis syndrome

Dehydration

Device related infection

Influenza

100%

80%

60%

40%

20%

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

~1880

doxorubicin

2005

Completed Phase 3

~9130

vinblastine

2010

Completed Phase 3

~1490

dacarbazine

2010

Completed Phase 3

~5030

0 / 3Eligibility criteria met

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

1,202 Previous Clinical Trials

4,176,928 Total Patients Enrolled

Seagen Inc.Industry Sponsor

207 Previous Clinical Trials

67,823 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

Frequently Asked Questions

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

Is this clinical trial limited to only North America?

"There are a total of 90 sites where this study is enrolling patients, with locations in cities such as Fresno, Albuquerque and Chattanooga. To cut down on travel time and stress, it would be ideal to select the location nearest you."

Answered by AI

What are brentuximab vedotin's most common applications?

"brentuximab vedotin, which is normally used to treat acute lymphoblastic leukemia (all), can also be given as a form of treatment to patients with advanced endometrial cancer, primary cutaneous anaplastic large cell lymphoma and classical hodgkin's lymphoma."

Answered by AI

How many individuals are acting as test subjects in this experiment?

"Unfortunately, this study is not currently looking for new patients. Although it was last updated recently on February 4th, 2022, the trial was first posted over 9 years ago on November 9th, 2012. There are other trials though! If you search for lymphoma clinical trials, there are 1764 that are actively enrolling participants right now. For brentuximab vedotin specifically, 453 trials are admitting patients."

Answered by AI

Are there other drug trials that have used brentuximab vedotin?

"Brentuximab vedotin was first studied in 1997 and has been the subject of 810 completed clinical trials since. As of now, 453 more studies are actively recruiting patients. A large number these brentuximab vedotin trials are based out of Fresno, California."

Answered by AI

Are there any dangers associated with brentuximab vedotin therapy?

"Brentuximab vedotin's safety is estimated to be a 3. This score comes from the fact that this treatment is in Phase 3 trials, so while there isn't extensive data on its efficacy, there are multiple rounds of data supporting its safety."

Answered by AI

Are currently enrolling individuals in this clinical trial?

"Recruitment for this study has concluded. It was originally posted on November 9th, 2012 and last edited on February 4th, 2022. If you are interested in other trials, there are 1764 active studies related to lymphoma and 453 involving brentuximab vedotin that are recruiting patients."

Answered by AI

Does this experiment differ significantly from others like it?

"brentuximab vedotin has been under clinical observation since 1997. The first set of trials were sponsored by Alfacell and conducted in the same year. These initial 300 cases allowed for brentuximab vedotin to be approved as a Phase 3 drug. In total, there are 453 active studies being done on brentuximab vedotin across 2039 cities in 67 countries."

Answered by AI

Recent research and studies

BloodJournal

Brentuximab Vedotin with Chemotherapy for Stage III/IV Classical Hodgkin Lymphoma: 3-year Update of the ECHELON-1 Study

Straus, David J., Monika Długosz-Danecka, Sergey Alekseev, Árpád Illés, Marco Picardi, Ewa Lech-Maranda, Tatyana Feldman, et al.. 2020. “Brentuximab Vedotin with Chemotherapy for Stage III/IV Classical Hodgkin Lymphoma: 3-year Update of the ECHELON-1 Study”. Blood. American Society of Hematology. doi:10.1182/blood.2019003127.

The Lancet HaematologyJournal

Brentuximab Vedotin with Chemotherapy for Stage III or IV Classical Hodgkin Lymphoma (ECHELON-1): 5-year Update of an International, Open-label, Randomised, Phase 3 Trial

Straus, David J, Monika Długosz-Danecka, Joseph M Connors, Sergey Alekseev, Árpád Illés, Marco Picardi, Ewa Lech-Maranda, et al.. 2021. “Brentuximab Vedotin with Chemotherapy for Stage III or IV Classical Hodgkin Lymphoma (ECHELON-1): 5-year Update of an International, Open-label, Randomised, Phase 3 Trial”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(21)00102-2.

New England Journal of MedicineJournal

Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin’s Lymphoma

Connors, Joseph M., Wojciech Jurczak, David J. Straus, Stephen M. Ansell, Won S. Kim, Andrea Gallamini, Anas Younes, et al.. 2018. “Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin’s Lymphoma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1708984.

The Lancet OncologyJournal