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Antibody Drug Conjugate
Brentuximab Vedotin for T-Cell Lymphoma
Phase 2
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 13 months after start of treatment
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 13 months after start of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 13 months after start of treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate
Secondary study objectives
Complete Response
Duration of Response
Overall Survival
+3 moreSide effects data
From 2017 Phase 2 trial • 10 Patients • NCT0180759840%
Fatigue
30%
Neutropenia
20%
Anorexia
20%
Abdominal Pain
20%
Constipation
20%
Cough
20%
Anemia
20%
Depression
20%
Diarrhea
20%
Dyspnea
20%
Infusion Related Reaction
20%
Rash
20%
Vomiting
10%
Intracranial hemorrhage
10%
Hyperhidrosis
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%
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 4
~210
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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is anaplastic large cell lymphoma, regardless of ALK status.I have a type of skin lymphoma that is not transformed Mycosis fungoides.I have not taken Brentuximab in the last 6 months or it did not work for me.I have severe nerve damage or Charcot-Marie-Tooth disease.I need treatment for a brain or spinal cord condition.I haven't had cancer in the last 3 years, except for skin cancer or a localized cancer that was treated to cure.I have had progressive multifocal leukoencephalopathy in the past.I have had a heart attack in the last 6 months.You have certain health conditions that may make it difficult for you to take part in the study.I do not have any ongoing or uncontrolled infections.I have a history of liver disease, including hepatitis B or C.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.You have had an allergic reaction to any part of the medication.I have heart problems like heart failure, blocked arteries, or irregular heartbeats.I haven't had chemotherapy or experimental drugs in the last 2 weeks.My T cell lymphoma has returned or didn't respond to treatment and has low CD30.It has been over 6 weeks since my stem cell transplant.My scans show cancer larger than 1.5 cm or cancer in my spleen/bone marrow.I will use effective birth control during and for 6 months after the study.My liver function tests are within the required limits.I am not pregnant and agree to use birth control during and 6 months after the study.My organs are working well.I have been diagnosed with HIV.I was treated with brentuximab vedotin over 6 months ago and it worked for me.It's been over 3 months since my stem cell transplant, I'm not on immunosuppressants, and I don't have GVHD.I have undergone at least one chemotherapy treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Brentuximab vedotin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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