Experimental drug shows promise for Hard-to-Treat lymphoma
NCT ID NCT02588651
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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23 people
The number who actually took part.
- Started
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Jun 2016
- Finished
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Oct 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195, United States
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Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
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University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106, United States
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Wayne State University, Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new drug combo revive immunotherapy for lymphoma?
- Can engineered cells beat relapsed blood cancers?
- Can a powerful combo of drugs and stem cell transplant beat tough lymphomas in kids?
- Can a simple blood test spot lymphoma earlier?
- Can a targeted antibody boost chemotherapy against a rare leukemia?