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Brentuximab Vedotin + CHEP for Adult T-Cell Leukemia/Lymphoma
Study Summary
This trial is studying how well BV-CHEP works in treating patients with ATLL.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 3 trial • 131 Patients • NCT01578499Trial Design
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Who is running the clinical trial?
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- I have been treated with brentuximab vedotin before.I have heart problems that cause symptoms.My liver is not working well (Child-Pugh Score > 6).My kidneys are not working well (creatinine clearance ≤ 30 mL/min).I do not have severe nerve damage.My brain scans show a lesion that may be active lymphoma.I am 18 years old or older.My biopsy confirms I have peripheral T-cell leukemia/lymphoma.I have tested positive for HTLV-1 with confirmatory tests.My kidney and liver functions are within the required range.I am a woman who can have children and have a recent negative pregnancy test.I have had at most one chemotherapy session in the last 4 weeks or have been on antiretroviral therapy.My cancer cells show CD30 presence.I am willing and able to follow the study's procedures.I am a male and will use birth control during and for 6 months after the study.I have another cancer that is growing and needs treatment.I can take care of myself and am up and about more than half of my waking hours.
- Group 1: Open-label, Multicenter, Single-Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Has the CHEP program been given authorization by the FDA?
"There is limited data that suggests CHEP's efficacy and safety, leading to the score of 2 on Power's scale."
What is the sample size of participants in this research project?
"At the present time, this particular study is not actively seeking to add more patients. The trial was initially posted on October 15th 2018 and has been updated most recently on November 30th 2022. If you are interested in other trials, there are 2817 clinical trials looking for participants with lymphoma and 59 CHEP studies currently enrolling individuals."
Is there still capacity for more participants in this research endeavor?
"According to clinicaltrials.gov, this medical study initiated in October 15th 2018 and last modified on November 30th 2022 is not presently accepting new candidates. Fortunately, there are 2876 other active trials which require participants at the moment."
Which other explorations have been undertaken concerning CHEP?
"Currently, there are 59 CHEP-related trials in progress with 6 of them at the most advanced stage. Most of these studies are located in Montvale, NJ however 1851 locations across the country offer clinical trial opportunities related to CHEP."
What maladies have been alleviated by CHEP treatments?
"CHEP is generally prescribed to treat hodgkin disease, however it can also be effective in managing systemic anaplastic large cell lymphoma and peripheral t-cell lymphoma when used as a first line of treatment."
Is this trial pioneering in its approach?
"Research into CHEP has been ongoing since 2011, with the initial study being sponsored by Seagen Inc. Following this first trial in which 79 patients were involved, Phase 2 drug approval was granted and there are currently 59 live clinical trials for CHEP across 630 cities and 31 nations."
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