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Monoclonal Antibodies
Combination Therapy for Hodgkin's Lymphoma
Phase 1
Waitlist Available
Led By Alex F Herrera
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of a combination of drugs to treat Hodgkin lymphoma that has come back or does not respond to treatment.
Who is the study for?
This trial is for patients with Hodgkin lymphoma that has returned or isn't responding to treatment. Participants must have had at least one prior therapy, weigh over 40 kg, and have a life expectancy of more than 3 months. They should not be stem cell transplant candidates or on certain treatments, and must not have severe heart conditions, recent serious infections, uncontrolled illnesses like HIV/HCV/HBV, or active CNS disease.Check my eligibility
What is being tested?
The trial tests the combination of brentuximab vedotin (a targeted cancer drug), cyclosporine (to improve bone marrow function), and verapamil hydrochloride (to help overcome cancer cell resistance). The study aims to find the best dose with manageable side effects for treating relapsed/refractory Hodgkin lymphoma.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to the drugs which can affect organs; blood disorders; fatigue; issues from drug infusion into the body; increased risk of infection due to lowered immunity; and possible negative impact on liver function as indicated by changes in specific blood tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting toxicity
Secondary outcome measures
Complete response rate assessed by Cheson 2014 criteria
Duration of complete response
Duration of overall response
+4 moreOther outcome measures
Percentage of CD30, CD68, and drug exporters
Pharmacokinetics of monomethyl auristatin E (MMAE)
Side effects data
From 2020 Phase 4 trial • 60 Patients • NCT0199053418%
Pyrexia
12%
Peripheral sensory neuropathy
10%
Diarrhoea
10%
Neuropathy peripheral
10%
Neutropenia
8%
Polyneuropathy
8%
Nausea
8%
Anaemia
8%
Upper respiratory tract infection
7%
Arthralgia
7%
Vomiting
7%
Decreased appetite
5%
Hypomagnesaemia
5%
Hypokalaemia
5%
Paraesthesia
5%
Asthenia
5%
Bronchitis
5%
Cough
5%
Alopecia
3%
Oral herpes
3%
Abdominal pain
3%
Back pain
3%
Aspartate aminotransferase increased
3%
Alanine aminotransferase increased
3%
Constipation
3%
Nasopharyngitis
3%
Neutrophil count decreased
3%
Bone pain
3%
Headache
3%
Depression
3%
Thrombocytopenia
3%
Tachycardia
3%
Subcutaneous abscess
3%
Pruritus
3%
Rash
2%
Klebsiella infection
2%
Toothache
2%
Ligament sprain
2%
Chills
2%
Fatigue
2%
Blood alkaline phosphatase increased
2%
Lymphocyte count decreased
2%
Oedema
2%
Procedural pain
2%
Gamma-glutamyltransferase increased
2%
Catheter site inflammation
2%
Chest pain
2%
Renal tubular disorder
2%
Anaphylactic reaction
2%
Malaise
2%
Hyperuricaemia
2%
Influenza
2%
Lymphoedema
2%
Dengue fever
2%
Blood lactate dehydrogenase increased
2%
Facial nerve disorder
2%
Extravasation
2%
General physical health deterioration
2%
Hodgkin's disease
2%
Blood thyroid stimulating hormone increased
2%
Genital haemorrhage
2%
Upper respiratory tract inflammation
2%
Oedema peripheral
2%
Soft tissue inflammation
2%
Temperature regulation disorder
2%
Vaccination site pain
2%
Liver disorder
2%
Breast cellulitis
2%
Platelet count decreased
2%
Weight decreased
2%
Hyperglycaemia
2%
Pain in extremity
2%
Autonomic neuropathy
2%
Dysgeusia
2%
Somnolence
2%
Insomnia
2%
Device related infection
2%
Herpes zoster
2%
Hordeolum
2%
Conjunctivitis
2%
Coxsackie viral infection
2%
Leukocytosis
2%
Leukopenia
2%
Ear pain
2%
Autoimmune thyroiditis
2%
Diplopia
2%
Pseudomonas infection
2%
Sinusitis
2%
Viral infection
2%
Contusion
2%
Haemoglobin decreased
2%
Pneumonia
2%
Device related sepsis
2%
Septic shock
2%
Urinary tract infection
2%
Serum sickness-like reaction
2%
Cerebrovascular accident
2%
Anxiety
2%
Pleural effusion
2%
Vena cava thrombosis
2%
Dyspnoea
2%
Dyspnoea exertional
2%
Nasal congestion
2%
Dermatitis
2%
Dermatitis acneiform
2%
Dermatitis allergic
2%
Dermatitis contact
2%
Erythema
2%
Pruritus generalised
2%
Rash macular
2%
Rash maculo-papular
2%
Rash papular
2%
Rash pruritic
2%
Urticaria
2%
Haematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brentuximab Vedotin 1.8 mg/kg
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cyclosporine, verapamil, brentuximab vedotin)Experimental Treatment5 Interventions
Patients receive cyclosporine PO BID on days 1-5, verapamil hydrochloride PO QID on days 1-5, and brentuximab vedotin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Verapamil
2006
Completed Phase 4
~2290
Brentuximab Vedotin
2015
Completed Phase 4
~1100
Verapamil Hydrochloride
2017
Completed Phase 1
~30
Cyclosporine
1997
Completed Phase 3
~1830
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,431 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,638 Total Patients Enrolled
Alex F HerreraPrincipal InvestigatorCity of Hope Medical Center
11 Previous Clinical Trials
1,532 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are planning to receive a hematopoietic stem cell transplant.You have received treatment with BV in the past and your disease remained stable or progressed, or you initially responded well to BV but then your condition worsened while still receiving BV.You have already received and not responded to at least one type of treatment, or your cancer has returned after treatment.You are allowed to have had a previous blood stem cell transplant.You cannot be taking any other experimental drugs, biological therapy, chemotherapy, or radiation therapy during the study.You have had an allergic reaction to a medication like BV in the past.You have difficulty swallowing capsules or have a condition that affects absorption of medication.You have a severe medical condition that may be life-threatening, or your organs are not functioning properly.You have had a heart attack in the past 6 months or have moderate to severe heart failure.You are expected to live for at least 3 more months.You are allowed to have received treatment with brentuximab vedotin before.You were diagnosed or treated for another type of cancer within the last 3 years.You are currently pregnant or breastfeeding.You have a medical condition that could be dangerous if you participate in the study.You have already received treatment for your medical condition but it did not work, or you have experienced a recurrence of your condition after treatment.You have to give your written permission to participate in the study and any additional procedures that are not part of your normal medical care. You can choose to stop participating in the study at any time, and it won't affect your future medical care.You weigh at least 40 kilograms.Your CT or PET scan shows a tumor that is bigger than 1.5 cm in your neck, chest, abdomen or pelvis.You have a current brain disease or a history of cancer that has spread to your brain.You are able to perform daily activities without significant difficulty, as determined by a score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.You or your legal guardian can read and understand the consent form, and agree to sign it.You must have a confirmed diagnosis of Hodgkin lymphoma through a biopsy or cell test.You must be willing to provide a small piece of tumor tissue from a recent biopsy or from an older biopsy done after your last treatment. If a biopsy is not safe or possible, the study PI may make an exception.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cyclosporine, verapamil, 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Brentuximab Vedotin a reliable therapeutic agent for patients?
"Due to the limited amount of supporting evidence, Brentuximab Vedotin earned a score of 1 on our team's safety scale. This is because this is only in Phase 1 and there has been no substantial data showing its efficacy or harmlessness."
Answered by AI
Are there any previous studies that have utilized Brentuximab Vedotin?
"Presently, there are 130 clinical trials for Brentuximab Vedotin with 18 Phase 3 studies. Montvale, New jersey is home to many of these studies; however, the drug's reach spans across 2,361 medical centres globally."
Answered by AI
What common afflictions is Brentuximab Vedotin prescribed to treat?
"Brentuximab Vedotin is a common medication for lupus nephritis, but it can also assist with the management of bullous disease, organ rejection after transplantation, and atrial fibrillation/flutter."
Answered by AI
Does this clinical trial currently have any openings for participants?
"The trial in question, which was first uploaded to clinicaltrials.gov on May 3rd 2017 and last updated February 17th 2022, is not currently recruiting patients. However, there are 1854 other studies actively seeking enrolment at this moment."
Answered by AI
How many people have enrolled in this clinical investigation?
"This trial has ceased its recruitment activities; the most recent alteration to its posting was on February 17th 2022. A search of hodgkin disease and Brentuximab Vedotin studies identified 1724 and 130 actively recruiting trials, respectively."
Answered by AI
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