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Experimental drug shows promise for Hard-to-Treat lymphoma

NCT ID NCT02588651

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called brentuximab vedotin in 23 people with a type of T-cell lymphoma that had stopped responding to or returned after prior chemotherapy. The drug is designed to seek out and kill cancer cells that have a specific marker called CD30, even when levels of that marker are very low. The main goal was to see how many patients' tumors shrank or disappeared after treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

23 people

The number who actually took part.

Started

Jun 2016

Finished

Oct 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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. * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106, United States

  • Wayne State University, Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

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