LymphomaPhase 2NCT03264131
BV-CHEP Chemotherapy for Adult T-cell Leukemia or Lymphoma
A Phase 2 study testing Brentuximab Vedotin and CHEP in people with Lymphoma and Adult T-Cell Leukemia/Lymphoma, run by UNC Lineberger Comprehensive Cancer Center at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Adult T-Cell Leukemia/Lymphoma, Lymphatic Diseases
- What is being tested?
- Brentuximab Vedotin and CHEP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Oct 2018to 15 Dec 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to participate in this study:
- Informed consent and HIPAA authorization for release of personal health information obtained.
- Age ≥ 18 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Histological confirmation of biopsy-proven peripheral T-cell leukemia/lymphoma consistent with ATLL
- Included subtypes will be: acute, lymphomatous, and chronic unfavorable. Chronic unfavorable is defined as the chronic variant with at least one of the following: lactate dehydrogenase (LDH)>upper limit of normal (ULN), blood urea nitrogen (BUN)>ULN, Albumin<lower limit of normal (LLN)
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- Positive human T-lymphotropic virus-1 (HTLV-1) antibody testing with confirmatory testing via Western blot, enzyme-linked immunosorbent assay (ELISA), or molecular testing (PCR).
- Documented negative serologic testing for human immunodeficiency virus (HIV).
- If positive for HBV exposure or prior infection, can continue to participate in trial with prophylactic entecavir (for HBV). If positive for hepatitis c virus (HCV) exposure or active infection, can participate in trial with monitoring for liver function abnormalities.
- Demonstrate adequate organ function as defined below; all screening labs to be obtained within three days prior to study treatment.
- System: Renal -Calculated creatinine clearance
- Laboratory Value: ≥ 30 mL/min using the Cockcroft-Gault formula for subjects with creatinine levels > 2.0 x institutional ULN
- System: Hepatic - Bilirubin
- Laboratory Value: ≤ 3.0 mg/dL
- System: Hepatic - Aspartate aminotransferase (AST)
- Laboratory Value: ≤ 2.5 × ULN
- System: Hepatic - Alanine aminotransferase (ALT)
- Laboratory Value: ≤ 2.5 × ULN
- Females of childbearing potential must have a negative serum pregnancy test within three days (72 hours) prior to initiating study treatment. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months.
- Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 24 weeks (6 months) after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets <1% failure rate for protection from pregnancy in the product label.
- Male patients with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 24 weeks (6 months) after the last dose of study therapy.
- As determined by the enrolling physician or protocol designee, willingness and ability of the subject to understand and comply with study procedures
- Prior Treatment: Previously untreated or has received a maximum of one cycle of any combination chemotherapy (e.g. cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP), CHOEP, DA-EPOCH, doxorubicin, cyclophosphamide, cytarabine, vincristine, methotrexate/Etoposide, ifosfamide, cytarabine, methotrexate (CODOX-M/IVAC), HyperCVAD) within 4 weeks of signing the main consent form. Additionally, a patient may have taken antiretroviral therapy (e.g. azidothymidine (AZT) and/or IFN) at any time prior to study enrollment
- CD30 expression determined by flow cytometry or IHC. NOTE: If CD30 testing was previously done on the biopsy sample from diagnosis, this information will be collected. If CD30 testing was not done, an archival sample from the biopsy used for diagnosis will be requested and tested for CD30. CD30 testing will also be done on the bone marrow tissue collected from the bone marrow exam. If we are unable to obtain an archival sample or if the bone marrow exam is negative, a new biopsy will be performed to confirm the diagnosis and test for CD30.
Who cannot join
- Subjects who meet any of the following criteria should be excluded from study participation:
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Has a known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least five years.
- Previous exposure to brentuximab vedotin (BV).
- History of allergic response to BV-CHEP or its components or to any of the required prophylactic medications or reasonable alternatives.
- Symptomatic cardiac disease including ventricular dysfunction, left ventricular ejection fraction < 40%, symptomatic coronary artery disease or symptomatic arrhythmias
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- Subjects with severe hepatic insufficiency Child-Pugh Score > 6
- Subjects with severe renal impairment (i.e., creatinine clearance ≤ 30 mL/min; see Appendix B - Renal Impairment Guidelines).
- Exclude patients with pre-existing neuropathy grade 2 or higher.
- Patients receiving prohibited medications listed in the patient handout provided in 11.4 Appendix D: Prohibited Medications or Those to be used with Caution (ie, ketoconazole, itraconazole, ritonavir, macrolide antibiotics, erythromycin phenytoin, phenobarbital, carbamazepine, and valproic acid).
- Patients with a parenchymal brain lesion thought to be consistent with active lymphoma on screening CT/MRI. Of note, patients with cerebrospinal fluid (CSF) involvement alone are not excluded.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Boston Medical Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02215
Lineberger Comprehensive Cancer Center at the University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
South Broward/Memorial Healthcare System
Hollywood, Florida, 33021
About this study
Official title: Brentuximab Vedotin With Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (BV-CHEP) for the Treatment of Adult T-Cell Leukemia/Lymphoma: A Pilot Study of the Rare Lymphoma Working Group
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.
Read more
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.
Read the detailed description
STUDY OBJECTIVES
Primary Objective To define the proportion of subjects with CR after 4-6 cycles of brentuximab vedotin in combination with cyclophosphamide, doxorubicin, etoposide, and prednisone (BV-CHEP) in the treatment of adult T-cell leukemia/lymphoma.
Secondary Objectives
To estimate the overall response rate (ORR) with 4-6 cycles of BV-CHEP therapy in patients with adult T-cell leukemia/lymphoma.
To determine progression-free survival (PFS) for BV-CHEP in patients with adult T-cell leukemia/lymphoma who received or did not receive BV maintenance.
To determine duration of response to BV-CHEP in patients with adult T-cell leukemia/lymphoma who received or did not receive BV maintenance.
To determine overall survival (OS) of patients with adult T-cell leukemia/lymphoma treated with BV-CHEP who received or did not receive BV maintenance therapy.
To evaluate the toxicity and tolerability of BV-CHEP and BV maintenance therapy via the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
*Note: After completion or withdrawal from BV-CHEP therapy, patients will segregate into one of the following groups: 1) those who progressed on BV-CHEP; 2) those who completed 4-6 cycles of BV-CHEP and went on to allogeneic transplant; 3) those who completed 6 cycles of BV-CHEP but were CD30 negative and ineligible for maintenance therapy; and 4) those who completed 6 cycles of BV-CHEP, were CD30 positive, but continued study treatment on BV in the maintenance phase of the study.
ENDPOINTS
Primary Endpoint
Criteria for CR after 4-6 cycles of BV-CHEP will be based on the International Workshop to standardize response criteria for malignant lymphomas (ie, Lugano Criteria per Cheson, et al. J Clin Oncol. 2014;32(27):3059-68).
Secondary Endpoints
Criteria for overall response will be based on the International Workshop to standardize response criteria for malignant lymphomas (ie, Lugano Criteria per Cheson, et al. J Clin Oncol. 2014;32(27):3059-68).
PFS is defined as time from D1 of treatment until disease progression (based on Lugano criteria) or death from any cause.
Duration of response is defined as the time from documentation of tumor response per Lugano criteria to disease progression
OS is defined as the time from D1 of treatment until death from any cause
Toxicity and tolerability of therapy will be assessed via the NCI CTCAE v4.03
TREATMENT INFORMATION
Patients will undergo screening to see if they are eligible. If eligible, participants will start by receiving 2 cycles of BV-CHEP (cycles 1 and 2). After 2 cycles of BV-CHEP, participants will have a positron emission tomography/computed tomography (PET/CT) or a CT scan to assess their disease. If the scan shows the cancer has stayed the same or gotten better, participants may continue taking BV-CHEP for two more cycles (cycle 3 and 4). If, at any time during study treatment, a participant's disease gets worse, the participant will end study treatment and other treatment options will be discussed with you.
If a participant continues on BV-CHEP, at the beginning of cycle 5, the participant will have a PET/CT scan. If the cancer has gotten better and the participant is eligible for a bone marrow transplant, he/she will have the transplant. If the participant is not eligible for a bone marrow transplant and the cancer has stayed the same or gotten better, the participant may continue on BV-CHEP for two more cycles (cycles 5 and 6).
At the end of cycle 6 of BV-CHEP, participants will have another PET/CT scan. If the scan shows the cancer has gotten better and the participant is eligible for a bone marrow transplant, he/she will have the transplant. If a participant is not eligible for a bone marrow transplant and his/her cancer cells did not test positive for CD30, the participant will end study treatment. The study doctor will discuss other treatment options that are not part of this study with the participant.
Participants may continue on brentuximab vedotin alone as maintenance therapy if:
- They are not eligible for a bone marrow transplant,
- Their cancer cells tested positive for CD30, and
- Their cancer has not gotten worse after taking BV-CHEP.
Participants will be removed from BV maintenance therapy if their cancer get worse.
DURATION OF THERAPY Therapy in LCCC 1637 involves up to 6 cycles of treatment with brentuximab vedotin (BV) with a chemotherapy treatment made up of cyclophosphamide, doxorubicin, etoposide, and prednisone (CHEP). Each cycle is 21 days long. Participants may continue on BV alone as maintenance therapy after 6 cycles of BV-CHEP if they meet the requirements outlined above. Each cycles of BV maintenance therapy is 21-day long. BV maintenance therapy may continue until a participant's disease progresses.
DURATION OF FOLLOW-UP PERIOD Participants will be followed for survival for up to 5 years. They will also have a PET/CT or CT scan and a blood test every 6 months for 2 years after study treatment ends.
- Conditions
- Lymphoma, Adult T-Cell Leukemia/Lymphoma, Lymphatic Diseases
- Being tested
- Brentuximab Vedotin, CHEP
- Keywords
- Brentuximab Vedotin, Adcetris, Lymphoma, Leukemia, CD30
- Medical subject headings
- Lymphoma, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphatic Diseases, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab VedotinDrug
Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days).
CHEPDrug
Cyclophosphamide- 750 mg/m^2 IV over approximately 1 hour on D1 every 21 days for 2-6 cycles
Doxorubicin- 50 mg/m^2 IV over approximately 3-5 minutes on D1 every 21 days for 2-6 cycles.
Etoposide - 100 mg/m^2 IV over approximately 1 hour each day for 3 days every 21 days for 2-6 cycles.
Prednisone - 100 mg, orally once daily for 5 days every 21 days for 2-6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Open-label, Multicenter, Single-Arm | Experimental | 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. Receives: Drug: Brentuximab Vedotin; Drug: CHEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate After 2-6 Cycles of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (BV-CHEP)
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 response on PET or < 50% decrease from baseline in SPD of up to 6 dominant, measurable nodes and extra nodal sites on CT. Progressive Disease: PET: Score 4 or 5 with an increase in the intensity of uptake or CT: an individual node/lesion must be abnormal with LDi > 1.5 cm, increase by ≥ 50% from the cross product of the LDi and shortest axis perpendicular to LDi (SDi).
Measured: 18 weeks
Secondary outcomes (6)
Overall Response Rate (ORR) Associated With 2-6 Cycles of BV-CHEP Therapy in Patients With Adult T-Cell Leukemia/Lymphoma.
ORR will be evaluated as the rate of complete responses (CR) + partial responses (PR) as defined by the International Workshop to standardize response criteria for malignant lymphomas (i.e. Lugano Criteria). Patients with leukemic component to their disease at baseline will be assessed per Adult T-Cell Leukemia/Lymphoma National Comprehensive Cancer Network (NCCN) guidelines version 2.2017
Measured: Up to 24 months
Progression-free Survival (PFS) for BV-CHEP in Patients With Adult T-cell Leukemia/Lymphoma
PFS is assessed from day 1 of treatment until disease progression (based on International Workshop to standardize response criteria for malignant lymphomas (i.e. Lugano Criteria) or death. Progression Free Survival (PFS) is calculated from the date of randomization to the date of progression or the date of death from any cause. The median PFS is estimated using the Kaplan-Meier method. The Measure of Dispersion reported is the Full Range, representing the minimum and maximum observed follow-up time (whether censored or event occurred) for all participants in this group.
Measured: Up to 15.2 months
Duration of Response to BV-CHEP in Patients With Adult T-cell Leukemia/Lymphoma
Duration of response is defined as the time from documentation of tumor response per Lugano criteria to disease progression. Subjects with a leukemic component to their disease at baseline will have peripheral blood assessed per adult T-cell leukemia/lymphoma NCCN Guidelines version 2.2017
Measured: Up to 24 months
Overall Survival (OS) of Patients With Adult T-cell Leukemia/Lymphoma Treated With BV-CHEP Who Received or Did Not Receive BV Maintenance Therapy.
Overall survival is defined as the time from date of randomization until death from any cause. The median OS is estimated using the Kaplan-Meier method. The Measure of Dispersion reported is the Full Range, representing the minimum and maximum observed follow-up time (whether censored or event occurred) for all participants in this group. BV maintenance was not reported because only one patient received it, and only for a limited number of dose.
Measured: Up to 68 months
BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
Toxicity and tolerability of therapy will be assessed via the NCI CTCAE v4.03, a scale from 1-mild to 5-death.Only treatment-attributed Grade ≥3 adverse events were included.
Measured: Up to 24 months
Progression-free Survival (PFS) for BV Maintenance
PFS will be measured from day 1 of treatment to disease progression (per the Lugano Criteria) or death. BV maintenance was minimal, with only one patient receiving a limited number of doses. The single analyzed participant experienced disease progression during the study period. Number of participant showed no progression is reported.
Measured: Up to Day 309
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start11 Oct 2018
- Primary completion15 Dec 2023
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seagen Inc.
- Responsible party
- Sponsor
- Investigators
- Dittus Christopher, DO, MPH, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264131
- Sponsor's protocol ID
- LCCC1637
- Status last verified
- Jun 2026
- First submitted
- 15 Aug 2017
- Last updated
- 29 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brentuximab Vedotin With Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (BV-CHEP) for the Treatment of Adult T-Cell Leukemia/Lymphoma: A Pilot Study of the Rare Lymphoma Working Group
- ClinicalTrials.gov ID
- NCT03264131
- Acronym / sponsor ID
- LCCC1637
- Conditions
- Lymphoma, Adult T-Cell Leukemia/Lymphoma, Lymphatic Diseases
- Keywords
- Brentuximab Vedotin, Adcetris, Lymphoma, Leukemia, CD30
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Seagen Inc.
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
STUDY OBJECTIVES
Primary Objective To define the proportion of subjects with CR after 4-6 cycles of brentuximab vedotin in combination with cyclophosphamide, doxorubicin, etoposide, and prednisone (BV-CHEP) in the treatment of adult T-cell leukemia/lymphoma.
Secondary Objectives
To estimate the overall response rate (ORR) with 4-6 cycles of BV-CHEP therapy in patients with adult T-cell leukemia/lymphoma.
To determine progression-free survival (PFS) for BV-CHEP in patients with adult T-cell leukemia/lymphoma who received or did not receive BV maintenance.
To determine duration of response to BV-CHEP in patients with adult T-cell leukemia/lymphoma who received or did not receive BV maintenance.
To determine overall survival (OS) of patients with adult T-cell leukemia/lymphoma treated with BV-CHEP who received or did not receive BV maintenance therapy.
To evaluate the toxicity and tolerability of BV-CHEP and BV maintenance therapy via the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03).
*Note: After completion or withdrawal from BV-CHEP therapy, patients will segregate into one of the following groups: 1) those who progressed on BV-CHEP; 2) those who completed 4-6 cycles of BV-CHEP and went on to allogeneic transplant; 3) those who completed 6 cycles of BV-CHEP but were CD30 negative and ineligible for maintenance therapy; and 4) those who completed 6 cycles of BV-CHEP, were CD30 positive, but continued study treatment on BV in the maintenance phase of the study.
ENDPOINTS
Primary Endpoint
Criteria for CR after 4-6 cycles of BV-CHEP will be based on the International Workshop to standardize response criteria for malignant lymphomas (ie, Lugano Criteria per Cheson, et al. J Clin Oncol. 2014;32(27):3059-68).
Secondary Endpoints
Criteria for overall response will be based on the International Workshop to standardize response criteria for malignant lymphomas (ie, Lugano Criteria per Cheson, et al. J Clin Oncol. 2014;32(27):3059-68).
PFS is defined as time from D1 of treatment until disease progression (based on Lugano criteria) or death from any cause.
Duration of response is defined as the time from documentation of tumor response per Lugano criteria to disease progression
OS is defined as the time from D1 of treatment until death from any cause
Toxicity and tolerability of therapy will be assessed via the NCI CTCAE v4.03
TREATMENT INFORMATION
Patients will undergo screening to see if they are eligible. If eligible, participants will start by receiving 2 cycles of BV-CHEP (cycles 1 and 2). After 2 cycles of BV-CHEP, participants will have a positron emission tomography/computed tomography (PET/CT) or a CT scan to assess their disease. If the scan shows the cancer has stayed the same or gotten better, participants may continue taking BV-CHEP for two more cycles (cycle 3 and 4). If, at any time during study treatment, a participant's disease gets worse, the participant will end study treatment and other treatment options will be discussed with you.
If a participant continues on BV-CHEP, at the beginning of cycle 5, the participant will have a PET/CT scan. If the cancer has gotten better and the participant is eligible for a bone marrow transplant, he/she will have the transplant. If the participant is not eligible for a bone marrow transplant and the cancer has stayed the same or gotten better, the participant may continue on BV-CHEP for two more cycles (cycles 5 and 6).
At the end of cycle 6 of BV-CHEP, participants will have another PET/CT scan. If the scan shows the cancer has gotten better and the participant is eligible for a bone marrow transplant, he/she will have the transplant. If a participant is not eligible for a bone marrow transplant and his/her cancer cells did not test positive for CD30, the participant will end study treatment. The study doctor will discuss other treatment options that are not part of this study with the participant.
Participants may continue on brentuximab vedotin alone as maintenance therapy if:
- They are not eligible for a bone marrow transplant,
- Their cancer cells tested positive for CD30, and
- Their cancer has not gotten worse after taking BV-CHEP.
Participants will be removed from BV maintenance therapy if their cancer get worse.
DURATION OF THERAPY Therapy in LCCC 1637 involves up to 6 cycles of treatment with brentuximab vedotin (BV) with a chemotherapy treatment made up of cyclophosphamide, doxorubicin, etoposide, and prednisone (CHEP). Each cycle is 21 days long. Participants may continue on BV alone as maintenance therapy after 6 cycles of BV-CHEP if they meet the requirements outlined above. Each cycles of BV maintenance therapy is 21-day long. BV maintenance therapy may continue until a participant's disease progresses.
DURATION OF FOLLOW-UP PERIOD Participants will be followed for survival for up to 5 years. They will also have a PET/CT or CT scan and a blood test every 6 months for 2 years after study treatment ends.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label, Multicenter, Single-Arm | Experimental | Drug: Brentuximab Vedotin, Drug: CHEPThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Informed consent and HIPAA authorization for release of personal health information obtained.
- Age ≥ 18 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Histological confirmation of biopsy-proven peripheral T-cell leukemia/lymphoma consistent with ATLL
- Documented negative serologic testing for human immunodeficiency virus (HIV).
Key exclusion criteria (11 listed)
- Subjects who meet any of the following criteria should be excluded from study participation:
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Has a known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least five years.
- Previous exposure to brentuximab vedotin (BV).
- History of allergic response to BV-CHEP or its components or to any of the required prophylactic medications or reasonable alternatives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brentuximab VedotinBrentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days). | Drug | Open-label, Multicenter, Single-Arm |
| CHEPCyclophosphamide- 750 mg/m^2 IV over approximately 1 hour on D1 every 21 days for 2-6 cycles Doxorubicin- 50 mg/m^2 IV over approximately 3-5 minutes on D1 every 21 days for 2-6 cycles. Etoposide - 100 mg/m^2 IV over approximately 1 hour each day for 3 days every 21 days for 2-6 cycles. Prednisone - 100 mg, orally once daily for 5 days every 21 days for 2-6 cycles. | Drug | Open-label, Multicenter, Single-Arm |
Primary outcome
Complete Response Rate After 2-6 Cycles of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (BV-CHEP)
Time frame: 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 response on PET or < 50% decrease from baseline in SPD of up to 6 dominant, measurable nodes and extra nodal sites on CT. Progressive Disease: PET: Score 4 or 5 with an increase in the intensity of uptake or CT: an individual node/lesion must be abnormal with LDi > 1.5 cm, increase by ≥ 50% from the cross product of the LDi and shortest axis perpendicular to LDi (SDi).
6 secondary outcomes
Overall Response Rate (ORR) Associated With 2-6 Cycles of BV-CHEP Therapy in Patients With Adult T-Cell Leukemia/Lymphoma.
Time frame: Up to 24 months
Progression-free Survival (PFS) for BV-CHEP in Patients With Adult T-cell Leukemia/Lymphoma
Time frame: Up to 15.2 months
Duration of Response to BV-CHEP in Patients With Adult T-cell Leukemia/Lymphoma
Time frame: Up to 24 months
Overall Survival (OS) of Patients With Adult T-cell Leukemia/Lymphoma Treated With BV-CHEP Who Received or Did Not Receive BV Maintenance Therapy.
Time frame: Up to 68 months
BV-CHEP and BV Maintenance Therapy-Attributed Grade ≥3 Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4)
Time frame: Up to 24 months
Progression-free Survival (PFS) for BV Maintenance
Time frame: Up to Day 309
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dittus Christopher, DO, MPH principal investigator
UNC Lineberger Comprehensive Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brentuximab Vedotin and CHEP in people with Lymphoma and Adult T-Cell Leukemia/Lymphoma, run by UNC Lineberger Comprehensive Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate After 2-6 Cycles of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (BV-CHEP) (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.