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Antibody Drug Conjugate

Brentuximab Vedotin for T-Cell Lymphoma

Phase 2
Recruiting
Led By Deepa Jagadeesh, MD, MPH
Research Sponsored by Deepa Jagadeesh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. ECOG Performance Status (PS) 3 will be permitted if the decreased PS is attributed to the lymphoma
Patients must have histologically or cytologically confirmed relapsed/refractory CD30 low (<10%) TCL: including peripheral TCL not otherwise specified (PTCL NOS), angioimmunoblastic T cell lymphoma (AITL), hepato-splenic T cell lymphoma (HTCL), adult T cell leukemia/lymphoma (ATLL), enteropathy associated T cell lymphoma (EATL), adult T cell leukemia/lymphoma (ATLL), enteropathy associated T cell lymphoma (EATL), NK T cell lymphoma (NK/TCL)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 13 months after start of treatment
Awards & highlights

Study Summary

This trial will study the use of Brentuximab Vedotin in patients with mature T-cell lymphoma who have been treated with at least one type of chemotherapy, but are not responding or the cancer has come back after the previous treatment.

Who is the study for?
This trial is for adults with certain types of T-cell lymphoma that have low levels of CD30 and haven't responded to or relapsed after at least one chemotherapy treatment. Participants must be in relatively good health, not pregnant, willing to use contraception, and able to understand the study. They can't join if they've had certain other cancers recently, active infections including hepatitis B or C, heart problems, a history of HIV or PML disease.Check my eligibility
What is being tested?
The trial tests Brentuximab Vedotin on mature T-cell lymphomas with low CD30 levels. It's an antibody drug conjugate combining an antibody targeting cancer cells and a cell-killing chemo agent. The goal is to see how effective it is against this specific type of lymphoma when previous treatments failed.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal cells (infusion reactions), nerve damage (neuropathy), fatigue, blood count changes which could increase infection risk or cause bleeding issues, liver function abnormalities and gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may not be able to do heavy physical work, or I'm mostly in bed due to my lymphoma.
Select...
My T cell lymphoma has returned or didn't respond to treatment and has low CD30.
Select...
It has been over 6 weeks since my stem cell transplant.
Select...
My scans show cancer larger than 1.5 cm or cancer in my spleen/bone marrow.
Select...
I will use effective birth control during and for 6 months after the study.
Select...
My liver function tests are within the required limits.
Select...
I am not pregnant and agree to use birth control during and 6 months after the study.
Select...
My organs are working well.
Select...
I was treated with brentuximab vedotin over 6 months ago and it worked for me.
Select...
It's been over 3 months since my stem cell transplant, I'm not on immunosuppressants, and I don't have GVHD.
Select...
I have undergone at least one chemotherapy treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 13 months after start of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 13 months after start of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate
Secondary outcome measures
Complete Response
Duration of Response
Overall Survival
+3 more

Side effects data

From 2017 Phase 2 trial • 10 Patients • NCT01807598
40%
Fatigue
30%
Neutropenia
20%
Constipation
20%
Abdominal Pain
20%
Anorexia
20%
Cough
20%
Anemia
20%
Depression
20%
Diarrhea
20%
Dyspnea
20%
Infusion Related Reaction
20%
Rash
20%
Vomiting
10%
Intracranial hemorrhage
10%
Respiratory, thoracic and mediastinal disorders - Other, Epiglottitis
10%
Thrombocytopenia
10%
Sinusitis
10%
Oral pain
10%
Edema limbs
10%
Portal vein thrombosis
10%
Pleural effusion
10%
Fever
10%
Nausea
10%
Alopecia
10%
Dry skin
10%
Hyperhidrosis
10%
Pruritus
10%
Upper respiratory infection
10%
Vaginal infection
10%
Sore throat
10%
Hypoalbuminemia
10%
Ascites
10%
Dysphagia
10%
Wound infection
10%
Postnasal drip
10%
Dehydration
10%
Insomnia
10%
Ear pain
10%
Watering eyes
10%
Pain in extremity
10%
Urinary frequency
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brentuximab Vedotin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Brentuximab vedotinExperimental Treatment1 Intervention
Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab vedotin
2012
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

Deepa JagadeeshLead Sponsor
2 Previous Clinical Trials
19 Total Patients Enrolled
Deepa Jagadeesh, MD, MPH5.01 ReviewsPrincipal Investigator - Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
3 Previous Clinical Trials
19 Total Patients Enrolled
Paolo Caimi, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
4 Previous Clinical Trials
106 Total Patients Enrolled
1 Trials studying Hepatosplenic T-cell Lymphoma
20 Patients Enrolled for Hepatosplenic T-cell Lymphoma

Media Library

Brentuximab Vedotin (Antibody Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT02588651 — Phase 2
Hepatosplenic T-cell Lymphoma Research Study Groups: Brentuximab vedotin
Hepatosplenic T-cell Lymphoma Clinical Trial 2023: Brentuximab Vedotin Highlights & Side Effects. Trial Name: NCT02588651 — Phase 2
Brentuximab Vedotin (Antibody Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02588651 — Phase 2

Frequently Asked Questions

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

To what purpose is Brentuximab vedotin most often put?

"Brentuximab vedotin, while most often used as a hodgkin disease treatment, can also be effective for patients with systemic anaplastic large cell lymphoma, peripheral t-cell lymphoma, and previously untreated."

Answered by AI

What is the difference between this clinical trial and others like it?

"Brentuximab vedotin has been under investigation since 2011 when the first study was conducted by Seagen Inc. After this initial Phase 1 clinical trial with 79 patients, Brentuximab vedotin received approval for Phase 2 trials. Currently, there are 62 active studies involving 31 countries and 627 cities."

Answered by AI

Has Brentuximab vedotin been cleared by the FDA?

"Brentuximab vedotin is classified as a Phase 2 drug, which means that while there is some evidence suggesting it is safe, there is no data yet to support its efficacy."

Answered by AI

Are there any active vacancies in this clinical trial for new patients?

"Yes, the trial is still ongoing and looking for new participants. The original posting was on 6/17/2016, with the most recent update being on 7/18/2022. 31 people are needed from 2 different locations."

Answered by AI

How many people will be included in this research project at most?

"Yes, according to the latest information from clinicaltrials.gov, this trial is still recruiting patients. The listing for this study was first posted on June 17th, 2016 and updated as recently as July 18th, 2022. At present, they are looking for 31 individuals at 2 different sites."

Answered by AI

Is Brentuximab vedotin a new medication?

"62 clinical trials are currently being conducted to study the efficacy of Brentuximab vedotin. Of those, 6 have reached Phase 3. However, these trials are not limited to Montvale, New jersey as there are 1,851 total locations running these sorts of studies."

Answered by AI
~1 spots leftby Jun 2024