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Monoclonal Antibodies
Chemotherapy for Hodgkin's Lymphoma (BV-ICE Trial)
Phase 1 & 2
Waitlist Available
Led By Ajay Gopal
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Absolute neutrophil count (ANC) >= 1,500/uL, performed within 28 days prior to registration
Patients must have primary refractory or first relapse of cluster of differentiation 30 (CD30)+ Hodgkin lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from initiation of therapy.
Awards & highlights
BV-ICE Trial Summary
This trial is studying brentuximab vedotin in combination with ifosfamide, carboplatin, and etoposide to see how well they work in treating patients with relapsed or refractory Hodgkin lymphoma.
Who is the study for?
This trial is for patients with Hodgkin lymphoma that hasn't responded to initial treatment or has returned. They must have a certain level of blood cells, organ function, and be able to complete two chemotherapy cycles. Pregnant individuals, those with HIV or other recent cancers (except some skin and in situ cancers), allergies to specific drugs used here, active central nervous system lymphoma, prior brentuximab vedotin use, significant neuropathy or heart issues are excluded.Check my eligibility
What is being tested?
The study is testing the combination of brentuximab vedotin (a targeted cancer drug) with ifosfamide, carboplatin, and etoposide (chemotherapy drugs). It aims to find the safest dose of brentuximab vedotin that can be given alongside these chemotherapies to treat relapsed/refractory Hodgkin lymphoma more effectively.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site; damage to blood cells leading to increased infection risk; fatigue; nausea; hair loss from chemotherapy; nerve damage causing numbness or tingling sensations; liver enzyme changes suggesting potential liver impact.
BV-ICE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My white blood cell count is healthy.
Select...
My Hodgkin lymphoma is not responding to initial treatment or has returned and tests positive for CD30.
Select...
I have a tumor that can be seen on scans or felt and is confirmed by a PET scan.
BV-ICE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years from initiation of therapy.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from initiation of therapy.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose of Brentuximab Vedotin That Can be Combined With Ifosfamide, Carboplatin, and Etoposide Chemotherapy
Percentage of Patients That Achieve a Complete Remission Following Study Treatment
Secondary outcome measures
2 Year Overall Survival
2 Year Progression-free Survival
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
BV-ICE Trial Design
3Treatment groups
Experimental Treatment
Group I: Phase II: Dose Expansion (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide)Experimental Treatment5 Interventions
Patients receive brentuximab vedotin 1.5mg/kgIV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.
Group II: Phase I: Dose Escalation, Dose Level 2 (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide)Experimental Treatment5 Interventions
Patients receive brentuximab vedotin 1.5mg/kgIV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.
Group III: Phase I: Dose Escalation, Dose Level 1 (brentuximab 1.2mg/kg, ifosfamide, carboplatin, etoposide)Experimental Treatment5 Interventions
Patients receive brentuximab vedotin 1.2mg/kgIV over 30 minutes on days 1 and 8; ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 2; and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients planning to go on to consolidative HDT and ASCT may undergo PBSC mobilization following the 2nd course of study therapy at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Ifosfamide
2010
Completed Phase 4
~2980
Brentuximab Vedotin
2015
Completed Phase 4
~1100
Etoposide
2010
Completed Phase 3
~2440
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,306 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,108 Total Patients Enrolled
Seagen Inc.Industry Sponsor
207 Previous Clinical Trials
69,112 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Phase II: Dose Expansion (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide)
- Group 2: Phase I: Dose Escalation, Dose Level 1 (brentuximab 1.2mg/kg, ifosfamide, carboplatin, etoposide)
- Group 3: Phase I: Dose Escalation, Dose Level 2 (brentuximab 1.5mg/kg, ifosfamide, carboplatin, etoposide)
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.
Has Brentuximab Vedotin been the subject of any other research endeavors?
"At the present time, 1582 trials involving Brentuximab Vedotin are underway with 372 of them in their final phase. The majority are situated in Philadelphia, but there exist a total of 71472 clinical experiment sites conducting research into this drug."
Answered by AI
What is the intake capacity for this investigation?
"At the current moment, this clinical trial is not actively recruiting. It was initiated on October 10th 2014 and its most recent update occured on June 28th 2022. For further information about active trials related to Hodgkin disease, 1723 studies are available; those searching for Brentuximab Vedotin have 1582 options for enrollment."
Answered by AI
Are there any openings available for this medical investigation?
"This clinical trial, which was initially posted on October 10th 2014 and last edited June 28th 2022, is not currently recruiting patients. Nevertheless, there are 3305 other trials actively searching for participants at this time."
Answered by AI
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