Your session is about to expire
← Back to Search
Monoclonal Antibodies
Brentuximab Vedotin + R-CHP for Non-Hodgkin's Lymphoma (BV mini CHP Trial)
Phase 2
Waitlist Available
Led By Patrick M Reagan, MD
Research Sponsored by Patrick Reagan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Composite lymphoma containing both indolent and large cell features
Men and women aged greater than or equal to 75 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
BV mini CHP Trial Summary
This trial is studying a new way to treat elderly patients with DLBCL by combining brentuximab vedotin with R-CHP.
Who is the study for?
This trial is for men and women aged 75 or older with a specific type of blood cancer called DLBCL. They must be able to consent, have an ECOG performance status of 0-3, no prior therapy for their condition (except possibly prednisone), and adequate liver function. People with certain other health conditions or treatments are excluded.Check my eligibility
What is being tested?
The study tests a combination of drugs: brentuximab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone in elderly patients with DLBCL. It modifies the standard R-CHOP regimen by omitting vincristine due to its overlapping toxicities with brentuximab vedotin.See study design
What are the potential side effects?
Potential side effects include nerve damage (neuropathy), reactions related to infusions, changes in blood counts leading to increased infection risk or bleeding problems, liver issues from elevated enzymes/bilirubin levels, fatigue and various digestive symptoms.
BV mini CHP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lymphoma has both slow-growing and aggressive features.
Select...
I am 75 years old or older.
Select...
I can care for myself but may not be able to do heavy physical work.
Select...
My cancer has changed its form and this was confirmed by a biopsy. I haven't received any treatment that includes anthracyclines.
Select...
My diagnosis of DLBCL is confirmed by a specialist.
BV mini CHP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent of Subjects Completing Regimen
Secondary outcome measures
Complete Response Rate
Overall Response Rate
Overall Survival
+1 moreOther outcome measures
Mean change in objective physical performance
Mean number of comorbidities
Number of participants with any documented change in the Older Americans Resources and Services social resources assessment.
+5 moreSide effects data
From 2017 Phase 2 trial • 10 Patients • NCT0180759840%
Fatigue
30%
Neutropenia
20%
Anorexia
20%
Constipation
20%
Cough
20%
Abdominal Pain
20%
Anemia
20%
Depression
20%
Diarrhea
20%
Dyspnea
20%
Infusion Related Reaction
20%
Rash
20%
Vomiting
10%
Thrombocytopenia
10%
Respiratory, thoracic and mediastinal disorders - Other, Epiglottitis
10%
Intracranial hemorrhage
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
BV mini CHP Trial Design
1Treatment groups
Experimental Treatment
Group I: BV+mini-R-CHPExperimental Treatment5 Interventions
Brentuximab vedotin 1.8 mg/kg IV day 1 for six cycles Rituximab 375 mg/m2 IV day 1 for six cycles Cyclophosphamide 400 mg/m2 IV day 1for six cycles Doxorubicin 25 mg/m2 IV day 1 for six cycles Prednisone 40 mg/m1 PO days 1-5 for six cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
2012
Completed Phase 3
~7940
Cyclophosphamide
1995
Completed Phase 3
~3770
Prednisone
2014
Completed Phase 4
~2370
Brentuximab vedotin
2012
Completed Phase 2
~200
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
Patrick ReaganLead Sponsor
Seagen Inc.Industry Sponsor
207 Previous Clinical Trials
69,133 Total Patients Enrolled
Patrick M Reagan, MDPrincipal InvestigatorWilmot Cancer Institute, University of Rochester Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lymphoma has both slow-growing and aggressive features.I understand the study details and am willing to sign the consent form.I am currently on dialysis.My heart's pumping ability is significantly reduced.I have not had treatment for DLBCL or HT, except possibly a short course of prednisone.I am being closely watched for hepatitis B symptoms during the study.My bilirubin levels are normal or slightly above, except if I have Gilbert syndrome.My kidney function is low, with a creatinine clearance under 30 mL/min.I am 75 years old or older.I can care for myself but may not be able to do heavy physical work.My cancer has changed its form and this was confirmed by a biopsy. I haven't received any treatment that includes anthracyclines.My diagnosis of DLBCL is confirmed by a specialist.I have had an organ transplant or a related lymph disorder.I have been treated with anthracycline before.My liver enzymes are within acceptable limits for the trial, even if slightly elevated due to my lymphoma.I do not have another active cancer that could affect the study results.I have moderate to severe numbness, tingling, or pain in my hands or feet.I have had a stem cell transplant from a donor.I have or had lymphoma in my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: BV+mini-R-CHP
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.
Have other investigations been undertaken to explore the efficacy of Brentuximab vedotin?
"Presently, there are 1,443 Brentuximab vedotin trials in progress with 305 of them at a Phase 3 stage. The majority of the studies on this drug occur in Bethesda, Maryland yet it is being studied world-wide as evidenced by 51,893 locations conducting related clinical research."
Answered by AI
Has the FDA endorsed Brentuximab vedotin as a viable therapeutic approach?
"Brentuximab vedotin is considered to have a moderate level of safety, with a score of 2. This evaluation stems from the fact that it has completed Phase 2 trials and while there are data points supporting its safety, none exist regarding efficacy."
Answered by AI
Are there still vacancies available in this clinical test?
"The details available on clinicaltrials.gov indicates that this particular research project is not accepting new participants at the moment. Initially posted in June 2016, with its last update occurring in June 2022, it appears to be closed for enrollment; however, there are over 3000 other active studies actively looking for volunteers currently."
Answered by AI
What conditions does Brentuximab vedotin typically address?
"Brentuximab vedotin has demonstrated success in the treatments of lung cancer, thyroiditis, polyangium and neuroblastoma (NB)."
Answered by AI
How many participants have volunteered to be involved in this trial?
"This research study is no longer actively accepting participants. Initially published on June 1st 2016 and last amended on the 24th of June 2022, this medical trial has since been closed off to new applicants. Alternatively, there are 1775 trials recruiting individuals with lymphoma, large b-cell diffuse and 1443 studies enlisting patients for Brentuximab vedotin treatments."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger