A Phase 2 interventional study of Brentuximab Vedotin and CHEP in Lymphoma, Adult T-Cell Leukemia/Lymphoma and Lymphatic Diseases, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Phase 2, Interventional, and Treatment
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.
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:
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.
3,018 studies on the registry are indexed under Lymphoma; 434 are open to participants now.
This study's enrollment of 16 is below the median of 43 across 2,319 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 429 studies on the registry; 97 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects must meet all of the following inclusion criteria to participate in this study:
Histological confirmation of -proven peripheral T-cell leukemia/lymphoma consistent with ATLL
Demonstrate adequate organ function as defined below; all screening labs to be obtained within three days prior to study treatment.
System: Renal -Calculated
Laboratory Value: ≥ 30 mL/min using the Cockcroft-Gault formula for subjects with creatinine levels > 2.0 x institutional ULN
System: Hepatic -
Laboratory Value: ≤ 3.0 mg/dL
System: Hepatic - (AST)
Laboratory Value: ≤ 2.5 × ULN
System: Hepatic - Alanine aminotransferase (ALT)
Laboratory Value: ≤ 2.5 × ULN
Exclusion Criteria:
Subjects who meet any of the following criteria should be excluded from study participation:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Brentuximab Vedotin · Drug: CHEP
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).
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.
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).
Time frame: 18 weeks
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
Time frame: 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.
Time frame: 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
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.
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.
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)
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.
Time frame: 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.
Time frame: Up to Day 309
Participants were enrolled in the study between 10/11/2018 - 06/22/2022 at four cancer centers in the United States.
| Milestone | Open-label, Multicenter, Single-Arm |
|---|---|
| Started | 16 |
| Completed | 16 |
| Not completed | 0 |
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).
| Participants | Open-label, Multicenter, Single-Arm |
|---|---|
| Complete Response | 10 |
| Partial Response | 4 |
| Progressive Disease | 2 |
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
| Participants | Open-label, Multicenter, Single-Arm |
|---|---|
| Overall Response Rate (ORR) Associated With 2-6 Cycles of BV-CHEP Therapy in Patients With Adult T-Cell Leukemia/Lymphoma. | 14 |
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.
| months | Open-label, Multicenter, Single-Arm |
|---|---|
| Progression-free Survival (PFS) for BV-CHEP in Patients With Adult T-cell Leukemia/Lymphoma | 7.11 (0.7 to 15.2) |
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
| months | Open-label, Multicenter, Single-Arm |
|---|---|
| Duration of Response to BV-CHEP in Patients With Adult T-cell Leukemia/Lymphoma | 3.84 (0.76 to 12.46) |
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.
| months | Open-label, Multicenter, Single-Arm |
|---|---|
| Overall Survival (OS) of Patients With Adult T-cell Leukemia/Lymphoma Treated With BV-CHEP Who Received or Did Not Receive BV Maintenance Therapy. | 15.7 (3.3 to 68) |
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.
| Participants | Open-label, Multicenter, Single-Arm |
|---|---|
| Anemia | 7 |
| Febrile neutropenia | 6 |
| Abdominal pain | 1 |
| Esophagitis | 1 |
| Mucositis oral | 3 |
| Nausea | 1 |
| Typhlitis | 1 |
| Vomiting | 1 |
| colitis | 1 |
| Lymphocyte count decreased | 3 |
| Neutrophil count decreased | 5 |
| Platelet count decreased | 4 |
| White blood cell decreased | 5 |
| Hypokalemia | 1 |
| Hyponatremia | 1 |
| Dyspnea | 1 |
| Sore throat | 1 |
| Hypotension | 1 |
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.
| Participants | Open-label, Multicenter, Single-Arm |
|---|---|
| Progression-free Survival (PFS) for BV Maintenance | 0 |
Collected over Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 68 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open-label, Multicenter, Single-Arm | 12/16 (75%) | 7/16 (43.8%) | 9/16 (56.3%) |
| Event | Open-label, Multicenter, Single-Arm |
|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 2/16 |
| General disorders and administration site conditions - Other, specifyGeneral disorders | 2/16 |
| Infections and infestations - Other, specifyInfections and infestations | 2/16 |
| Hearing impairedEar and labyrinth disorders | 1/16 |
| Eye painEye disorders | 1/16 |
| ConstipationGastrointestinal disorders | 1/16 |
| Mucositis oralGastrointestinal disorders | 1/16 |
| TyphlitisGastrointestinal disorders | 1/16 |
| VomitingGastrointestinal disorders | 1/16 |
| FatigueGeneral disorders | 1/16 |
| Event | Open-label, Multicenter, Single-Arm |
|---|---|
| AnemiaBlood and lymphatic system disorders | 7/16 |
| NauseaGastrointestinal disorders | 7/16 |
| Mucositis oralGastrointestinal disorders | 6/16 |
| ChillsGeneral disorders | 6/16 |
| HeadacheNervous system disorders | 6/16 |
| Abdominal painGastrointestinal disorders | 5/16 |
| DiarrheaGastrointestinal disorders | 5/16 |
| DizzinessNervous system disorders | 5/16 |
| FatigueGeneral disorders | 4/16 |
| Investigations - Other, specifyInvestigations | 4/16 |
Participants consented and started the study.
| Age, Continuous(years) | Open-label, Multicenter, Single-Arm |
|---|---|
| Median | 56 (43.75 to 65.50) |
| Sex: Female, Male(Participants) | Open-label, Multicenter, Single-Arm |
|---|---|
| Female | 12 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Open-label, Multicenter, Single-Arm |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 15 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Open-label, Multicenter, Single-Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 14 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Open-label, Multicenter, Single-Arm |
|---|---|
| United States | 16 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2018 to primary completion in Dec 2023, 62 months.
Results were first posted in Feb 2025, 1 year 1 month after primary completion.
Of 237 non-industry phase 2 interventional studies under Lymphoma, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 114. This study's 62 months is close to that.
Counting every sponsor, half of 293 studies reached it within 61 months; a quarter within 36 and three quarters within 105.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Brentuximab Vedotin
UNC Lineberger Comprehensive Cancer Center →