NCT03264131

BV-CHEP Chemotherapy for Adult T-cell Leukemia or Lymphoma

Active, enrolled Phase 2 Results posted Last updated 10 February 2025

What this trial tests

Phase 2 trial testing Brentuximab Vedotin in Lymphoma in 16 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

11 October 2018

Primary endpoint
15 December 2023

15 December 2028

Quick facts

Lead sponsor	UNC Lineberger Comprehensive Cancer Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	11 October 2018
Primary completion	15 December 2023
Estimated completion	15 December 2028
Sites	4 locations across United States

Drugs / interventions tested

• Brentuximab Vedotin — full drug profile →
• CHEP — full drug profile →

Conditions studied

• Lymphoma — all drugs for Lymphoma →
• Adult T-Cell Leukemia/Lymphoma — all drugs for Adult T-Cell Leukemia/Lymphoma →
• Lymphatic Diseases — all drugs for Lymphatic Diseases →

Sponsor

UNC Lineberger Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Lymphoma or Adult T-Cell Leukemia/Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Complete Response Rate After 2-6 Cycles of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (BV-CHEP) Primary · 18 weeks

The response was assessed based on the International Workshop to standardize response criteria for malignant lymphomas (i.e., Lugano Criteria per Cheson, et al. J Clin Oncol. 2014;32(27):3059-68; Complete Response: Positron emission tomography (PET): Complete metabolic response Computerized tomography (CT): Target must regress to ≤ 1.5 cm in the largest transverse diameter (LDi) or no extra lymphatic sites of disease. Partial Response: PET: reduced uptake compared with baseline, and CT: ≥50% decrease in the sum of the products of diameters (SPD).No Response or Stable Disease: No metabolic resp

Complete Response

Group	Value	95% CI
Open-label, Multicenter, Single-Arm	10

Partial Response

Group	Value	95% CI
Open-label, Multicenter, Single-Arm	4

Progressive Disease

Group	Value	95% CI
Open-label, Multicenter, Single-Arm	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Open-label, Multicenter, Single-Arm

Serious: 7/16 (44%)

Deaths: 12/16

Serious adverse events (17 terms)

Reaction	System	Open-label, Multicenter, S…
Febrile neutropenia	Blood and lymphatic system disorders	—
General disorders and administration site conditions - Other, specify	General disorders	—
Infections and infestations - Other, specify	Infections and infestations	—
Hearing impaired	Ear and labyrinth disorders	—
Eye pain	Eye disorders	—
Constipation	Gastrointestinal disorders	—
Mucositis oral	Gastrointestinal disorders	—
Typhlitis	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Fatigue	General disorders	—
Fever	General disorders	—
pain	General disorders	—
Neutrophil count decreased	Investigations	—
Platelet count decreased	Investigations	—
Weight loss	Investigations	—
Dehydration	Metabolism and nutrition disorders	—
Bone pain	Musculoskeletal and connective tissue disorders	—

Other adverse events (77 terms — click to expand)

Reaction	System	Open-label, Multicenter, S…
Anemia	Blood and lymphatic system disorders	—
Nausea	Gastrointestinal disorders	—
Mucositis oral	Gastrointestinal disorders	—
Chills	General disorders	—
Headache	Nervous system disorders	—
Abdominal pain	Gastrointestinal disorders	—
Diarrhea	Gastrointestinal disorders	—
Dizziness	Nervous system disorders	—
Fatigue	General disorders	—
Investigations - Other, specify	Investigations	—
Neutrophil count decreased	Investigations	—
Platelet count decreased	Investigations	—
Back pain	Musculoskeletal and connective tissue disorders	—
Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	—
Vomiting	Gastrointestinal disorders	—
General disorders and administration site conditions - Other, specify	General disorders	—
Lymphocyte count decreased	Investigations	—
Anorexia	Metabolism and nutrition disorders	—
Hyponatremia	Metabolism and nutrition disorders	—
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	—
Insomnia	Psychiatric disorders	—
Sore throat	Respiratory, thoracic and mediastinal disorders	—
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	—
Sinus tachycardia	Cardiac disorders	—
Constipation	Gastrointestinal disorders	—
Dysphagia	Gastrointestinal disorders	—
Gastroesophageal reflux disease	Gastrointestinal disorders	—
Oral pain	Gastrointestinal disorders	—
Fever	General disorders	—
Alkaline phosphatase increased	Investigations	—
Aspartate aminotransferase increased	Investigations	—
White blood cell decreased	Investigations	—
Metabolism and nutrition disorders - Other, specify	Metabolism and nutrition disorders	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Myalgia	Musculoskeletal and connective tissue disorders	—
Neck pain	Musculoskeletal and connective tissue disorders	—
Dysgeusia	Nervous system disorders	—
Peripheral sensory neuropathy	Nervous system disorders	—
Tremor	Nervous system disorders	—
Anxiety	Psychiatric disorders	—

Most-reported serious reactions: Febrile neutropenia, General disorders and administration site conditions - Other, specify, Infections and infestations - Other, specify, Hearing impaired, Eye pain, Constipation, Mucositis oral, Typhlitis.

Data from ClinicalTrials.gov NCT03264131 adverse events section.

Sponsor's own description

Adult T-cell leukemia/lymphoma (ATLL) is a rare form of cancer found mostly among people from the Caribbean islands, Western Africa, Brazil, Iran, and Japan. Most cases of this disease in the United States occur along the East Coast due to emigration from the Caribbean islands. There is currently no standard treatment for ATLL. Research shows that patients who go into first time remission (respond completely or partially to treatment) and have a bone marrow transplant have the best outcomes. Traditional chemotherapy treatments have generally not worked well in patients with ATLL. Additionally, not all patients will be eligible for a bone marrow transplant.

The purpose of this study is to see how well individuals with ATLL respond to an investigational cancer treatment. This investigational treatment combines a drug called brentuximab vedotin with a standard chemotherapy treatment made up of cyclophosphamide, doxorubicin, etoposide, and prednisone. This treatment is considered investigational because it is not approved by the United States Food and Drug Administration (FDA) for the treatment of ATLL.

Brentuximab vedotin, also known as Adcetris, is approved by the United States Food and Drug Administration (FDA) for treatment of certain types of lymphomas, including peripheral T-cell lymphomas when combined with cyclophosphamide, doxorubicin, and prednisone in patients whose cancer cells express a type of marker called CD30.

Brentuximab vedotin is an antibody that also has a chemotherapy drug attached to it. Antibodies are proteins that are part of the immune system. They can stick to and attack specific targets on cancer cells. The antibody part of brentuximab vedotin sticks to a target called cluster of differentiation 30 (CD30) that is located on the outside of the cancer cells. Normal cells have little or no CD30 on their surface. ATLL cancer cells often have a larger amount of CD30 on their surface than normal cells. However, CD30 is found in different amounts on ATLL cancer cells. This study will also test the amount of CD30 found on each participant's cancer cells. Researchers will be looking to see if the response to the study treatment varies based on the amount of CD30 found on the outside participants' cancer cells.

In another study, brentuximab vedotin was combined in another study with cyclophosphamide, doxorubicin, and prednisone. The study included patients with various types of T-cell lymphomas. Two of the patients enrolled in that study had ATLL. Both had a complete response (no evidence of disease). The researchers in this study (LCCC 1637) have added etoposide to the combination of brentuximab vedotin with cyclophosphamide, doxorubicin, and prednisone. They predict that the addition of etoposide will improve patient outcomes. Research shows that etoposide helps improve outcomes in patients with certain types of T-cell lymphomas who undergo chemotherapy treatment. This investigational combination of brentuximab vedotin with cyclophosphamide, doxorubicin, etoposide, and prednisone is called BV-CHEP.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibody-Drug Conjugates for the Treatment of Acute Pediatric Leukemia.
   Stokke JL, Bhojwani D. · · 2021 · cited 19× · PMID 34441852 · DOI 10.3390/jcm10163556
2. Chimeric Antigen Receptor Based Cellular Therapy for Treatment Of T-Cell Malignancies.
   Polgárová K, Otáhal P, Šálek C, Pytlík R. · · 2022 · cited 14× · PMID 35600381 · DOI 10.3389/fonc.2022.876758
3. Mechanism of action and therapeutic targeting of CD30 molecule in lymphomas.
   Li Z, Guo W, Bai O. · · 2023 · cited 11× · PMID 38188299 · DOI 10.3389/fonc.2023.1301437
4. Treatment of Adult T-Cell Leukemia/Lymphoma: Established Paradigms and Emerging Directions.
   Stuver R, Horwitz SM, Epstein-Peterson ZD. · · 2023 · cited 6× · PMID 37300656 · DOI 10.1007/s11864-023-01111-1
5. Advances and Personalized Approaches in the Frontline Treatment of T-Cell Lymphomas.
   Angelos MG, Ballard HJ, Barta SK. · · 2022 · cited 6× · PMID 35207754 · DOI 10.3390/jpm12020267
6. Antibody-Drug Conjugates Targeting CD30 in T-Cell Lymphomas: Clinical Progression and Mechanism.
   Jiang Y, Dong S, Wang Y. · · 2025 · cited 5× · PMID 39941862 · DOI 10.3390/cancers17030496
7. New treatments for adult T-cell leukemia/lymphoma.
   Epstein-Peterson ZD, Gurumurthi A, Horwitz SM. · · 2025 · cited 5× · PMID 39847921 · DOI 10.1016/j.leukres.2025.107642
8. [Advances in the treatment of CD30 positive lymphoma with brentuximab vedotin].
   Cai MC, Xu PP, Zhao WL. · · 2023 · cited 1× · PMID 36987732 · DOI 10.3760/cma.j.issn.0253-2727.2023.01.018