ClinicalTrials.gg
CompletedNCT03409432Updated Aug 13, 2026Results posted

Brentuximab Vedotin and Lenalidomide in Treating Patients With Stage IB-IVB Relapsed or Refractory T-Cell Lymphoma

A Phase 2 interventional study of Brentuximab Vedotin and Laboratory Biomarker Analysis in Lymphomatoid Papulosis, Primary Cutaneous Anaplastic Large Cell Lymphoma and Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, sponsored by John Reneau. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by John Reneau · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This phase II trial studies how well brentuximab vedotin and lenalidomide work in treating patients with stage IB-IVB T-cell lymphoma that have come back or do not respond to treatment. Monoclonal antibodies, such as brentuximab vedotin, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving brentuximab vedotin and lenalidomide may work better in treating patients with T-cell lymphoma.

Read the detailed description

PRIMARY OBJECTIVES:

I. To determine the overall response rate (ORR) of the combination of brentuximab vedotin (BV) and lenalidomide in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL)/peripheral T-cell lymphoma (PTCL).

SECONDARY OBJECTIVES:

I. To estimate the duration of response and 2 year progression-free survival (PFS) and overall survival (OS) associated with the combination of brentuximab vedotin (BV) and lenalidomide in patients with relapsed or refractory CTCL/PTCL.

II. To define the qualitative and quantitative toxicities of the combination of brentuximab vedotin (BV) and lenalidomide in patients with relapsed or refractory CTCL/PTCL.

TERTIARY OBJECTIVES:

I. To correlate between the expression of CD30 in neoplastic cells by immunohistochemistry (IHC) and overall response rate (ORR) of the combination of brentuximab vedotin (BV) and lenalidomide in patients with relapsed or refractory CTCL/PTCL.

II. To determine T-cell and natural killer (NK) cell subset numbers, phenotype, and functional status in relapsed or refractory (rel/ref) CTCL/PTCL patients, and whether the combination of brentuximab vedotin and lenalidomide alters these parameters during therapy.

III. To determine changes in plasma cytokine levels and other biomarkers in this patient population during therapy with the combination of brentuximab vedotin and lenalidomide.

OUTLINE:

Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1 and lenalidomide orally (PO) once daily (QD) on day 1-21. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years.

02

Conditions studied

  • Lymphomatoid Papulosis
  • Primary Cutaneous Anaplastic Large Cell Lymphoma
  • Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Recurrent T-Cell Non-Hodgkin Lymphoma
  • Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Stage I Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Stage II Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Stage III Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Stage IV Cutaneous T-Cell Non-Hodgkin Lymphoma
03

In context

Lymphoma, T-Cell, Cutaneous

554 studies on the registry are indexed under Lymphoma, T-Cell, Cutaneous; 63 are open to participants now.

This study's enrollment of 26 is below the median of 35 across 405 interventional studies indexed under Lymphoma, T-Cell, Cutaneous.

Browse Lymphoma, T-Cell, Cutaneous studies →

Lead sponsor

John Reneau is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Able to understand and voluntarily sign an form
  • Able to adhere to the study visit schedule and other protocol requirements
  • -proven, measurable, stage IB-IVB cutaneous T-cell lymphoma after 2 lines of skin-directed therapy or one

    • (Note: extracorporeal photopheresis will be considered a systemic therapy for this study)
  • Patients with large cell transformation of cutaneous T cell lymphoma are eligible
  • Patients with advanced stage non-mycosis fungoides (MF) CTCL are eligible including, but not limited to, advanced stage lymphomatoid papulosis (LyP) or primary cutaneous anaplastic large cell lymphoma (pcALCL)
  • Patients with systemic T cell lymphoma of any stage and any subtypes; patient must have had at least one standard chemotherapy and at the time of enrollment; bidimensional measurable disease of at least 1.5 cm in the greatest transverse diameter as documented by computed tomography (CT) or positron emission tomography (PET)/CT
  • Patients with systemic T cell lymphomas who relapsed after transplant are eligible
  • Prior treatment with brentuximab vedotin is allowed provided the patient did not progress on BV or within 30 days of last dose of BV; patients must be at least 3 months from the last dose of BV
  • CD30 staining is to be performed on fresh biopsy or archival formalin-fixed paraffin-embedded (FFPE) tissue however CD30 positivity is not required for eligibility
  • All cancer therapy, including radiation, topical , and chemotherapy must have been discontinued at least 1 week or 3 half-lives whichever is the longest prior to treatment in this study; the only exceptions are participants who are symptomatic from their skin lesions and have been on corticosteroids for prolonged periods of time (> 60 days) without change may continue use of either systemic steroids (equivalent to \< 10 mg per day of prednisone) or topical steroids are eligible for this study if the frequency and dosage steroids has not changed for 60 days prior to the study; these participants should continue on the same dose of systemic/topical steroid throughout the study period unless they achieve a complete response at which time steroids can be discontinued; patients are allowed to continue any medications with known activity in T cell lymphomas at the pre-enrollment doses for conditions other than T cell lymphomas (ie, steroids for sarcoidosis), as long as there is evidence of T cell lymphoma progression while patients were on these agents
  • (ECOG) performance status of =\< 2 at study entry
  • >= 1000/mm\^3
  • count >= 50,000/mm\^3
  • Total =\< 2 x (ULN)
  • (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 3 x ULN
  • AST (SGOT) and ALT (SGPT) =\< 5 x ULN in patients with documented hepatic involvement by lymphoma
  • Calculated >= 60 ml/min (by the Cockcroft-Gault equation)
  • Disease free of prior for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast; patients with early stage of prostate cancer under clinical surveillance without therapy are eligible
  • Negative serum pregnancy test at the time of enrollment for females of
  • Women of childbearing potential must follow pregnancy testing requirements as outlined in the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program material; this is defined as either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of (one highly effective method and one additional effective method (AT THE SAME TIME) at least 28 days prior to the start of lenalidomide, for the duration of study participation, and for 28 days following the last doses of brentuximab vedotin and lenalidomide; women of childbearing potential must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a woman of childbearing potential even if they have had a successful vasectomy; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
  • All study participants must be registered into the mandatory Revlimid REMS program and be willing to comply with its requirements; per standard Revlimid REMS program requirements, all physicians who prescribe lenalidomide for research subjects enrolled into this trial, must be registered in, and must comply with, all requirements of the Revlimid REMS program
  • > 30 days

Exclusion criteria

Exclusion Criteria:

  • Patients with active central nervous system (CNS) involvement with lymphoma are not eligible
  • Patients with pre-existing grade >= 3 peripheral neuropathy
  • Patients with known (HIV) infection or are not eligible
  • Patients who had solid organ transplants are not eligible
  • Evidence of active infection, based on positive surface antigen or hepatitis B deoxyribonucleic acid (DNA) polymerase chain reaction (PCR), or active infection; patients who are hepatitis B core antibody positive must take prophylaxis with lamivudine or equivalent and be willing to undergo monthly hepatitis B DNA PCR testing
  • Present or history of progressive multifocal leukoencephalopathy (PML)
  • Prior stem cell transplant is not permitted
  • Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction likely to interfere with the delivery, absorption, or metabolism of lenalidomide
  • Patients may take for disease control up to 24 hours prior to study enrollment; topical steroids are allowed for CTCL patients as described in inclusion criteria above
  • Any illness, medical condition or organ system dysfunction which, in the investigator?s opinion, could compromise the subject?s safety, interfere with the absorption or metabolism of lenalidomide, or put the study outcomes at undue risk
  • A cardiovascular disability status of class >= 2
  • History of severe allergic reactions to humanized monoclonal antibodies
  • History of other that could affect compliance with the protocol or interpretation of results; patients with a history of curatively treated basal or squamous cell carcinoma or stage 1 melanoma of the skin or in situ carcinoma of the cervix are eligible; individuals in documented remission without treatment for 2 years prior to enrollment may be included at the discretion of the investigator; patients with early stage of prostate cancer under clinical surveillance without therapy are eligible
  • Known to any of the study drugs or analogs
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior study therapy
  • history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Receipt of live-virus vaccines within 28 days prior to the initiation of study treatment or need for live-virus vaccines at any time during study treatment
  • Recent major surgery (within 6 weeks prior to the start of study treatment) other than for diagnosis
  • Receiving therapy
  • to prior therapy with brentuximab vedotin (evidence of progression within 30 days of the last dose)
  • Prior therapy with lenalidomide
  • Pregnant or lactating, or intending to become pregnant during the study
Terms in these criteria, in plain language(25)

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.

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.

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.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

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.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

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.

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.

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.

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.

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.

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.

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.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

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.

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.

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Treatment (brentuximab vedotin, lenalidomide)

    Patients receive brentuximab vedotin IV over 30 minutes on day 1 and lenalidomide PO QD on day 1-21. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.

    Drug: Brentuximab Vedotin · Other: Laboratory Biomarker Analysis · Drug: Lenalidomide

Interventions

  • Given IV

    Also known as: ADC SGN-35, Adcetris, Anti-CD30 Antibody-Drug Conjugate SGN-35, Anti-CD30 Monoclonal Antibody-MMAE SGN-35, Anti-CD30 Monoclonal Antibody-Monomethylauristatin E SGN-35, cAC10-vcMMAE, SGN-35

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • Given PO

    Also known as: CC-5013, CC5013, CDC 501, Revlimid

06

What researchers measure

Primary outcomes

  1. Overall Response Rate

    The overall response rate (ORR) of the combination of brentuximab vedotin (BV) and lenalidomide in patients with relapsed or refractory CTCL/PTCL. . ORR is defined as the proportion of patients who achieve complete response (CR) or partial response (PR). Response (CR, PR, SD) and progression will be defined using the Global Response Score

    Time frame: Up to 2 years

Secondary outcomes

  1. Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0

    Toxicity will be graded by the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0

    Time frame: Up to 30 days after last day of study treatment

  2. Overall Survival (OS)

    Kaplan-Meier method will be used to estimate OS.

    Time frame: From start of study treatment to date of death due to any cause, assessed up to 2 years

  3. Progression Free Survival (PFS)

    Kaplan-Meier method will be used to estimate PFS.

    Time frame: From start of study treatment to first documentation of tumor progression (including radiographic and clinical progression) or to death due to any cause, whichever comes first, assessed up to 2 years

07

Results

Posted Aug 13, 2026

Participant flow

Participant flow — Overall Study
MilestoneTreatment (Brentuximab Vedotin, Lenalidomide)
Started26
Completed22
Not completed4
Withdrew: Lost to follow-up1
Withdrew: Withdrawal by subject2
Withdrew: Disease progression1

Outcome measures

PrimaryOverall Response Rate

The overall response rate (ORR) of the combination of brentuximab vedotin (BV) and lenalidomide in patients with relapsed or refractory CTCL/PTCL. . ORR is defined as the proportion of patients who achieve complete response (CR) or partial response (PR). Response (CR, PR, SD) and progression will be defined using the Global Response Score

Time frame:
Up to 2 years
Reported as:
Number · Percentage of participants
Overall Response Rate
Percentage of participantsTreatment (Brentuximab Vedotin, Lenalidomide)
Overall Response Rate34.6 (17.2 to 55.7)
SecondaryIncidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0

Toxicity will be graded by the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0

Time frame:
Up to 30 days after last day of study treatment
Reported as:
Number · Number of participants
Incidence of Adverse Events According to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.0
Number of participantsTreatment (Brentuximab Vedotin, Lenalidomide)
Diarrhea14
Lymphocyte count decreased12
Anemia11
White blood cell decreased11
Neutrophil count decreased10
Rash maculo-papular10
Fatigue9
Aspartate aminotransferase increased8
Nausea8
Peripheral sensory neuropathy8
Platelet count decreased7
Abdominal pain6
Constipation6
Edema limbs6
Myalgia5
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify5
Pruritus5
Alkaline phosphatase increased4
Anorexia4
Malaise4
Vomiting4
Alanine aminotransferase increased3
Dizziness3
Dysgeusia3
Gastrointestinal disorders - Other, specify3
Musculoskeletal and connective tissue disorder - Other, specify3
Skin and subcutaneous tissue disorders - Other, specify3
Weight loss3
Blood bilirubin increased2
Fever2
Hyperglycemia2
Hypoalbuminemia2
Hypokalemia2
Hypomagnesemia2
Hypothyroidism2
Infusion related reaction2
Pain2
Pain in extremity2
Skin hyperpigmentation2
Stomach pain2
Thromboembolic event2
Allergic rhinitis1
Alopecia1
Bloating1
Bruising1
CD4 lymphocytes decreased1
Colitis1
Creatinine increased1
Depression1
Dyspepsia1
Dyspnea1
Fall1
Fracture1
Gait disturbance1
General disorders and administration site conditions - Other, specify1
Generalized muscle weakness1
Headache1
Hoarseness1
Hot flashes1
Hyperhidrosis1
Hypocalcemia1
Hypoglycemia1
Hypotension1
Immune system disorders - Other, specify1
Infections and infestations - Other, specify1
Lung infection1
Muscle weakness lower limb1
Paresthesia1
Portal vein thrombosis1
Respiratory, thoracic and mediastinal disorders - Other, specify1
Skin infection1
Skin ulceration1
Urinary tract infection1
Vertigo1
Weight gain1
SecondaryOverall Survival (OS)

Kaplan-Meier method will be used to estimate OS.

Time frame:
From start of study treatment to date of death due to any cause, assessed up to 2 years
Reported as:
Median · Months
Overall Survival (OS)
MonthsTreatment (Brentuximab Vedotin, Lenalidomide)
Overall Survival (OS)22.6 (11.7 to 42.8)
SecondaryProgression Free Survival (PFS)

Kaplan-Meier method will be used to estimate PFS.

Time frame:
From start of study treatment to first documentation of tumor progression (including radiographic and clinical progression) or to death due to any cause, whichever comes first, assessed up to 2 years
Reported as:
Median · Months
Progression Free Survival (PFS)
MonthsTreatment (Brentuximab Vedotin, Lenalidomide)
Progression Free Survival (PFS)6.7 (2.9 to 19.9)

Adverse events

Collected over Assessed up to 2 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Brentuximab Vedotin, Lenalidomide)16/26 (61.5%)7/26 (26.9%)26/26 (100%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventTreatment (Brentuximab Vedotin, Lenalidomide)
ColitisGastrointestinal disorders1/26
DyspneaRespiratory, thoracic and mediastinal disorders1/26
FeverGeneral disorders and administration site conditions1/26
FractureInjury, poisoning and procedural complications1/26
Lung infectionInfections and infestations1/26
Portal vein thrombosisHepatobiliary disorders1/26
Rash maculo-papularSkin and subcutaneous tissue disorders1/26
Respiratory, thoracic and mediastinal disorders - Other, specifyRespiratory, thoracic and mediastinal disorders1/26
SepsisInfections and infestations1/26
Skin and subcutaneous tissue disorders - Other, specifySkin and subcutaneous tissue disorders1/26
Most frequent other events
Showing 10 of 128
Most frequent other events
EventTreatment (Brentuximab Vedotin, Lenalidomide)
DiarrheaGastrointestinal disorders14/26
Lymphocyte count decreasedInvestigations13/26
AnemiaBlood and lymphatic system disorders12/26
White blood cell decreasedInvestigations11/26
HyperglycemiaMetabolism and nutrition disorders10/26
HypoalbuminemiaMetabolism and nutrition disorders10/26
Neutrophil count decreasedInvestigations10/26
Rash maculo-papularSkin and subcutaneous tissue disorders10/26
Edema limbsGeneral disorders and administration site conditions9/26
FatigueGeneral disorders and administration site conditions9/26

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Treatment (Brentuximab Vedotin, Lenalidomide)
Median60 (37 to 90)
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Brentuximab Vedotin, Lenalidomide)
Female8
Male18
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (Brentuximab Vedotin, Lenalidomide)
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American2
White21
More than one race2
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Treatment (Brentuximab Vedotin, Lenalidomide)
United States26
Prior Therapies
Prior Therapies(Number of prior therapies)Treatment (Brentuximab Vedotin, Lenalidomide)
Median4.5 (1 to 9)
Histology and Stage
Histology and Stage(Participants)Treatment (Brentuximab Vedotin, Lenalidomide)
Mycosis fungoides (MF)13
Peripheral T-cell lymphomas (PTCL)8
Sezary syndrome (SS)3
CD30+ lymphoproliferative disorders (LPD)2
CD30 Positive
CD30 Positive(Participants)Treatment (Brentuximab Vedotin, Lenalidomide)
No4
Yes18
Unknown4
Large cell transformation (only applicable to MF and SS)
Large cell transformation (only applicable to MF and SS)(Participants)Treatment (Brentuximab Vedotin, Lenalidomide)
No7
Yes5
Unknown4

2 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Ohio State University Comprehensive Cancer Center
    Columbus, Ohio 43210, United States
09

References and documents

Related links

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03409432
Lead sponsor
John Reneau
Collaborators
Celgene Corporation
Responsible party
John Reneau (Principal Investigator, Ohio State University Comprehensive Cancer Center) — Sponsor-investigator
First posted
Jan 24, 2018
Start date
Mar 16, 2018
Primary completion
Jul 16, 2025
Completion
Jul 16, 2025
Results posted
Aug 13, 2026
Last update
Aug 13, 2026

Study contacts

John Reneau, MD
principal investigator · Ohio State University Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Brentuximab Vedotin · Lenalidomide

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