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T-cell LymphomaPhase 2NCT02588651

A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low (<10%) Mature T Cell Lymphoma (TCL)

A Phase 2 study testing Brentuximab vedotin in people with T-cell Lymphoma and Angioimmunoblastic T-cell Lymphoma, run by Deepa Jagadeesh at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will include patients with mature T-cell lymphoma (MTCL) that has been treated with at least one type of chemotherapy, but is not responding or coming back after the previous treatment. This clinical trial uses a drug called Brentuximab Vedotin. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Brentuximab vedotin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
4 sitesUnited States
Study dates
17 Jun 2016to 14 Oct 2024
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

  • Patients must have histologically or cytologically confirmed relapsed/refractory CD30 low (<10%) TCL: including peripheral TCL not otherwise specified (PTCL NOS), angioimmunoblastic T cell lymphoma (AITL), hepato-splenic T cell lymphoma (HTCL), adult T cell leukemia/lymphoma (ATLL), enteropathy associated T cell lymphoma (EATL), adult T cell leukemia/lymphoma (ATLL), enteropathy associated T cell lymphoma (EATL), NK T cell lymphoma (NK/TCL)
  • At least 1 prior chemotherapy regimen
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. ECOG Performance Status (PS) 3 will be permitted if the decreased PS is attributed to the lymphoma
  • Adequate organ function
  • Bilirubin ≤1.5X upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3X ULN even in patients with documented hepatic involvement with lymphoma
  • Serum creatinine clearance ≥30 ml/min
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  • Absolute neutrophil count (ANC) ≥1000/μL (unless documented bone marrow involvement with lymphoma)
  • Platelet count ≥50,000/μL (unless documented bone marrow involvement with lymphoma)
  • At least 6 weeks from autologous stem cell transplantation
  • At least 3 months from allogeneic stem cell transplantation and off immunosuppression and no evidence of graft versus host disease (GVHD)
  • Previous treatment with brentuximab vedotin will be allowed if it was done 6 months prior to enrollment and patient was not refractory
  • Measurable disease ≥1.5 cm seen on computed tomography (CT) scan and Fluorodeoxyglucose (FDG) avid disease on positron emission Tomography (PET) scan. Splenomegaly measuring >12 cm, if attributed to TCL and/or positive bone marrow involvement with lymphoma are also eligible.
  • Females of childbearing potential must have a negative serum or urine pregnancy test result within 7 days prior to the first dose of study treatment. Women of child-bearing age must agree to use an effective contraception method during the study and for at least 6 months following the last dose of study drug.
  • Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 6 months following the last dose of study drug.
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Anaplastic large cell lymphoma (ALCL) both alk positive and negative
  • Cutaneous T cell lymphomas except transformed Mycosis fungoides (MF)
  • Prior treatment with Brentuximab in the last 6 months or previously refractory to Brentuximab Vedotin (BV) or had progressive disease (PD) while on BV
  • Pregnancy or breast feeding women
  • Prior malignancy within the past 3 years except non melanoma skin cancer or other localized cancer treated with curative intent
  • Presence of grade >2 peripheral neuropathy or patients with the demyelinating form of Charcot-Marie-Tooth syndrome.
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  • Presence of central nervous system (CNS) involvement requiring active treatment
  • History of progressive multifocal leukoencephalopathy (PML)
  • Myocardial infarction within the past 6 months
  • Patients with the following medical conditions that could affect their participation in the study:
  • any active acute or chronic or uncontrolled infection
  • liver disease including history of viral hepatitis B or C, evidence of cirrhosis, chronic active or persistent hepatitis
  • a known history of HIV
  • symptomatic cardiac disease, including congestive heart failure, coronary artery disease, and arrhythmias
  • Prior hypersensitivity to any component in the ADC formulation
  • Treatment with chemotherapy or investigational agents within 2 weeks of start of study treatment

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

  • Wayne State University, Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

Other trials in United States

About this study

This study will include patients with mature T-cell lymphoma (MTCL) that has been treated with at least one type of chemotherapy, but is not responding or coming back after the previous treatment.

This clinical trial uses a drug called Brentuximab Vedotin. The Food and Drug Administration (FDA) has approved Brentuximab Vedotin for sale in the United States for certain diseases. Brentuximab is still being studied in clinical trials like this one to learn more about what its side effects are and whether or not it is effective in the disease or condition being studied.

Read more

Brentuximab Vedotin is a type of drug called an antibody drug conjugate (ADC). ADCs usually have 2 parts; a part that targets cancer cells (the antibody) and a cell killing part (the chemotherapy). Antibodies are proteins that are part of your immune system. They can stick to and attack specific targets on cells. The antibody part of Brentuximab Vedotin sticks to a target called CD30. CD30 is an important molecule on some cancer cells (including non Hodgkin lymphoma) and some normal cells of the immune system. The cell killing part of Brentuximab Vedotin is a chemotherapy called monomethyl auristatin E (MMAE). It can kill cells that the antibody part of Brentuximab Vedotin sticks to. Brentuximab Vedotin has also been shown to kill cancer cells with levels of CD30 that cannot be seen by traditional methods.

This study is being done to test if the study drug has an effect on Mature T cell Lymphoma with such low levels of a target called CD30 and how your disease respond to the study drug.

Read the detailed description

Primary Objective

  • To determine overall response rate (CR+PR) of brentuximab vedotin in CD30 low (<10%) relapsed or refractory T cell lymphoma (TCL)

Secondary Objective(s)

  • Complete remission (CR) rate
  • Duration of response (DOR)
  • Progression free survival (PFS)
  • Overall survival (OS)
  • Time to treatment failure (TTF)
Being tested
Brentuximab vedotin
Keywords
Lymphoma, Leukemia, Brentuximab Vedotin
Medical subject headings
Lymphoma, T-Cell, Immunoblastic Lymphadenopathy, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Enteropathy-Associated T-Cell Lymphoma, Lymphoma, Extranodal NK-T-Cell, Lymphoma, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brentuximab vedotinDrug

    study drug given intravenously to determine efficacy in study diseases

Study groups in NCT02588651
Study groupRoleWhat they receive
Brentuximab vedotinExperimentalBrentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks
Receives: Drug: Brentuximab vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    The primary objective is to evaluate overall response rate (ORR). Overall response rate will be estimated by the total number of patients who achieve a CR and PR divided by the total number of patients who received treatment. Response was assessed using CT scans according to the revised Cheson criteria.

    • CR is defined as complete resolution of all clinically detectable disease and disease related symptoms that were present prior to therapy
    • PR is defined as at least 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses Patients should have completed at least 1 cycle of treatment to be evaluable for ORR.

    Measured: Three years after end of treatment, up to 49 months

Secondary outcomes (6)

  1. Complete Response

    Complete Response is defined as complete resolution of all clinically detectable disease and disease related symptoms that were present prior to therapy. A post-treatment residual mass of any size is permitted as long as it is PET negative. CR rate was calculated by dividing the total number of patients who have achieved a complete response by the total number of patients who received treatment.

    Measured: Three years after end of treatment, up to 49 months

  2. Progression Free Survival

    Progression-free survival (PFS) is defined as the time from treatment initiation into the study to disease progression or death due to any cause. The distribution of PFS will be estimated using the Kaplan-Meier method. Disease progression may be defined as the date of documentation of a new lesion or enlargement of a previous lesion, or the date of the scheduled clinic visit immediately after radiologic assessment has been completed. For a patient who is alive without progression at the end of study follow-up, observation of PFS is censored on the date of last contact.

    Measured: Three years after end of treatment, up to 49 months

  3. Overall Survival

    The overall survival (OS) is defined as the time from treatment initiation to the time of death due to any cause. For a patient who is alive at the end of study follow-up, observation of OS is censored on the date of last contact. The distribution of OS will be estimated using the Kaplan-Meier method.

    Measured: Three years after end of treatment, up to 49 months

  4. Duration of Response

    Duration of response (DOR) among responders is defined as the time from first documentation of objective tumor response (CR or PR) to the time of first progression or death due to any cause.

    Measured: Three years after end of treatment, up to 49 months

  5. Time to Treatment Failure (TTF)

    Time to treatment failure (TTF) is defined as the time from treatment initiation to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death. Date of last follow-up was collected for patients who did not have disease progression, but it is unknown for which reasons treatment was stopped for these patients. In this case, time to treatment failure (TTF) is the same as time to progression.

    Measured: Up to 13 months after start of treatment

  6. Time to Response (TTR)

    Time to treatment failure (TTR) is defined as time from treatment initiation to first documentation of objective tumor response (CR or PR).

    Measured: Three years after end of treatment, up to 49 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2015 (estimated)
  2. Study start17 Jun 2016
  3. Primary completion14 Oct 2024
  4. Study completion14 Oct 2024

Resources

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
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02588651
Sponsor's protocol ID
CASE1415
Status last verified
Nov 2025
First submitted
26 Oct 2015
Last updated
21 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brentuximab vedotin in people with T-cell Lymphoma and Angioimmunoblastic T-cell Lymphoma, run by Deepa Jagadeesh 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 15 inclusion and 16 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 21 Nov 2025. 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 21 Nov 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?

Overall Response Rate (time frame: Three years after end of treatment, up to 49 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02588651.

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 21 Nov 2025.

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