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Monoclonal Antibodies

Brentuximab Vedotin + CHEP for Adult T-Cell Leukemia/Lymphoma

Phase 2
Waitlist Available
Led By Dittus Christopher, DO, MPH
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years at the time of consent
Histological confirmation of biopsy-proven peripheral T-cell leukemia/lymphoma consistent with ATLL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is studying how well BV-CHEP works in treating patients with ATLL.

Who is the study for?
This trial is for adults over 18 with a specific type of cancer called Adult T-cell leukemia/lymphoma (ATLL), who have not been treated or have had only one round of chemotherapy. They must test negative for HIV, show adequate organ function, and if they can bear children, agree to use effective contraception methods. People with severe liver or kidney problems, active brain lymphoma lesions, certain other cancers, allergies to the study drugs or components, taking prohibited medications, previous brentuximab vedotin treatment, significant neuropathy or symptomatic heart disease are excluded.Check my eligibility
What is being tested?
The trial tests an investigational treatment named BV-CHEP which combines brentuximab vedotin (an FDA-approved drug for some lymphomas) with standard chemotherapy drugs cyclophosphamide, doxorubicin, etoposide and prednisone. The aim is to see if this combination works better in patients whose ATLL cells express CD30 protein markers.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response such as inflammation in various organs; infusion-related reactions; fatigue; digestive issues like nausea and diarrhea; blood disorders that could affect cell counts leading to increased infection risk; potential nerve damage causing numbness or tingling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My biopsy confirms I have peripheral T-cell leukemia/lymphoma.
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I have tested positive for HTLV-1 with confirmatory tests.
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My kidney and liver functions are within the required range.
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My cancer cells show CD30 presence.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cyclophosphamide
Secondary outcome measures
Duration of response to BV-CHEP in patients with adult T-cell leukemia/lymphoma who received or did not receive BV maintenance.
Overall response rate (ORR) associated with 2-6 cycles of BV-CHEP therapy in patients with adult T-Cell leukemia/lymphoma.
Overall survival (OS) of patients with adult T-cell leukemia/lymphoma treated with BV-CHEP who received or did not receive BV maintenance therapy.
+2 more

Side effects data

From 2018 Phase 3 trial • 131 Patients • NCT01578499
47%
Peripheral sensory neuropathy
36%
Nausea
27%
Diarrhoea
27%
Fatigue
17%
Vomiting
17%
Pruritus
15%
Alopecia
15%
Decreased appetite
14%
Pyrexia
12%
Myalgia
12%
Arthralgia
11%
Asthenia
11%
Oedema peripheral
11%
Rash maculo-papular
11%
Dyspnoea
11%
Pruritus generalised
9%
Paraesthesia
9%
Pain in extremity
9%
Weight decreased
9%
Hypertension
8%
Dysgeusia
8%
Headache
8%
Urticaria
8%
Neutropenia
8%
Hyperglycaemia
6%
Peripheral motor neuropathy
6%
Dizziness
6%
Chills
6%
Upper respiratory tract infection
6%
Hyperuricaemia
6%
Urinary tract infection
6%
Muscle spasms
5%
Anaemia
5%
Constipation
5%
Alanine aminotransferase increased
3%
Skin infection
3%
Insomnia
3%
Cough
3%
Cellulitis
2%
Drug eruption
2%
Cancer pain
2%
Diverticulitis
2%
Sepsis
2%
Impetigo
2%
Sinusitis
2%
Extravasation
2%
General physical health deterioration
2%
Multiple organ dysfunction syndrome
2%
Neuropathy peripheral
2%
Musculoskeletal chest pain
2%
Hypotension
2%
Dry skin
2%
Peripheral swelling
2%
Hypertriglyceridaemia
2%
Lower respiratory tract infection
2%
Fracture
2%
Lymphoma
2%
Neck pain
2%
Hepatocellular injury
2%
Intestinal perforation
2%
Haemolytic uraemic syndrome
2%
Pancreatitis
2%
Pulmonary embolism
2%
Urinary retention
2%
Stress
2%
Aspartate aminotransferase increased
2%
Staphylococcal skin infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brentuximab Vedotin
Methotrexate or Bexarotene

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-label, Multicenter, Single-ArmExperimental Treatment2 Interventions
This is a single-arm intervention where patients will receive concurrent therapy with BV+CHEP [(brentuximab vedotin; 1.8 mg/kg IV, on D1 every 21 days) (cyclophosphamide 750 mg/m^2 on D1; doxorubicin 50 mg/m^2 on D1, etoposide 100 mg/m^2 IV infusion on D1-3; prednisone 100 mg orally once daily on D1-5; cycle length every 21 days)] for 2 to 6 cycles of induction therapy. After 6 cycles of BV + CHEP, responders (CR, PR or SD) who are not eligible for BMT and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV, every 21 days) until disease progression, withdrawal due to toxicity or death.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab Vedotin
2015
Completed Phase 4
~1100

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
348 Previous Clinical Trials
88,228 Total Patients Enrolled
Seagen Inc.Industry Sponsor
206 Previous Clinical Trials
69,323 Total Patients Enrolled
Dittus Christopher, DO, MPHPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center

Media Library

Brentuximab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03264131 — Phase 2
Adult T-Cell Leukemia/Lymphoma Research Study Groups: Open-label, Multicenter, Single-Arm
Adult T-Cell Leukemia/Lymphoma Clinical Trial 2023: Brentuximab Vedotin Highlights & Side Effects. Trial Name: NCT03264131 — Phase 2
Brentuximab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03264131 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~2 spots leftby Mar 2025