Brentuximab vedotin for Mycosis Fungoides

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
MD Anderson Cancer Center, Houston, TX
Mycosis Fungoides+1 More
Brentuximab vedotin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

To learn if a form of radiation therapy (called ultra-low-dose - total skin electron beam therapy [ULD-TSEBT]) in combination with brentuximab vedotin can help to control mycosis fungoides

Eligible Conditions

  • Mycosis Fungoides

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Mycosis Fungoides

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: through study completion, an average of 1 year

Year 1
To establish the overall response rate (ORR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Mycosis Fungoides

Side Effects for

Brentuximab Vedotin
40%Fatigue
30%Neutropenia
20%Dyspnea
20%Anorexia
20%Cough
20%Constipation
20%Depression
20%Rash
20%Infusion Related Reaction
20%Vomiting
20%Diarrhea
20%Anemia
20%Abdominal Pain
10%Wound infection
10%Hyperhidrosis
10%Intracranial hemorrhage
10%Pleural effusion
10%Sinusitis
10%Pain in extremity
10%Upper respiratory infection
10%Alopecia
10%Vaginal infection
10%Respiratory, thoracic and mediastinal disorders - Other, Epiglottitis
10%Nausea
10%Ascites
10%Edema limbs
10%Dry skin
10%Dysphagia
10%Postnasal drip
10%Hypoalbuminemia
10%Dehydration
10%Sore throat
10%Ear pain
10%Insomnia
10%Urinary frequency
10%Watering eyes
10%Pruritus
10%Thrombocytopenia
10%Fever
10%Oral pain
10%Portal vein thrombosis
This histogram enumerates side effects from a completed 2017 Phase 2 trial (NCT01807598) in the Brentuximab Vedotin ARM group. Side effects include: Fatigue with 40%, Neutropenia with 30%, Dyspnea with 20%, Anorexia with 20%, Cough with 20%.

Trial Design

1 Treatment Group

Brentuximab vedotin
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Brentuximab vedotin · No Placebo Group · Phase 2

Brentuximab vedotin
Drug
Experimental Group · 1 Intervention: Brentuximab vedotin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab vedotin
2012
Completed Phase 2
~260

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year
Closest Location: MD Anderson Cancer Center · Houston, TX
Photo of MD Anderson Cancer Center  1Photo of MD Anderson Cancer Center  2Photo of MD Anderson Cancer Center  3
2004First Recorded Clinical Trial
8 TrialsResearching Mycosis Fungoides
520 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients with relapsed/refractory mycosis fungoides, who have ever expressed or currently express at least 1% CD30 assessed by biopsy within 6 months prior to study enrollment, are eligible.
You have previously received systemic anticancer therapy.
You are eligible for the test if you are at least 18 years of age.
You have a performance status score of ≤ 3 (APPENDIX 5).
You are HIV positive and you are on stable antiretroviral treatment.
You are able to understand the nature and risks of the study and are willing to sign a written informed consent document.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.