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

NCT02588651 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CASE1415
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

Brief 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. 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. 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.

Conditions

T-cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Hepato-splenic T-cell Lymphoma; Adult T-cell Leukemia/Lymphoma; Enteropathy Associated T-cell Lymphoma; NK T-cell Lymphoma

Keywords

Lymphoma; Leukemia; Brentuximab Vedotin

Outcome Measures

Primary Outcomes (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.

  Three years after end of treatment, up to 49 months

Secondary Outcomes (6)

• Complete Response

  Three years after end of treatment, up to 49 months

• Progression Free Survival

  Three years after end of treatment, up to 49 months

• Overall Survival

  Three years after end of treatment, up to 49 months

• Duration of Response

  Three years after end of treatment, up to 49 months

• Time to Treatment Failure (TTF)

  Up to 13 months after start of treatment

Study Arms (1)

Brentuximab vedotin

EXPERIMENTAL

Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks

Drug: Brentuximab vedotin

Interventions

Brentuximab vedotin DRUG

study drug given intravenously to determine efficacy in study diseases

Brentuximab vedotin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Deepa Jagadeesh: lead

Study Sites (4)

Wayne State University, Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell; Immunoblastic Lymphadenopathy; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Enteropathy-Associated T-Cell Lymphoma; Lymphoma, Extranodal NK-T-Cell; Lymphoma; Leukemia

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphadenopathy; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Principal Investigator
• Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

TaussigResearch@ccf.org

1-866-223-8100

Study Officials

• Deepa Jagadeesh, MD, MPH

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Paolo Caimi, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 28, 2015
• Study Start: June 17, 2016
• Primary Completion: October 14, 2024
• Study Completion: October 14, 2024
• Last Updated: November 21, 2025
• Results First Posted: November 21, 2025

Record last verified: 2025-11

Locations

US (4)