Pilot Study of Brentuximab Vedotin in Relapsed/Refractory Peripheral T-Cell Lymphoma Expressing CD30

NCT01841021 | Terminated Results

• 2 other identifiers: MCC-1734335-IST-019
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to test if brentuximab vedotin has an effect on cancer in patients with a certain type of large B-cell lymphoma. The side effects (unwanted effects) of SGN-35 in patients with this certain type of large B-cell lymphoma will also be studied. It is not known if brentuximab vedotin is better or worse than other treatment patients might be given.

Conditions

Peripheral T-Cell Lymphoma

Keywords

Peripheral T-Cell Lymphoma (PTCL); Relapsed; Refractory; CD30 Receptor; Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR: The proportion of patients with complete response (CR) and partial response (PR). Follow-up assessments after cycle 16 to be done every 12 weeks for up to 24 months. Restaging imaging computed tomography (CT) scans to be repeated 12 and 24 months from the beginning of the follow-up period. Objective disease response (CR and PR) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL). CR = Disappearance of all evidence of disease; PR = Regression of measurable disease and no new sites.

  Up to 24 months post treatment

Secondary Outcomes (6)

• Time to Response (TTR)

  Up to 24 months post treatment

• Duration of Response (DOR)

  Up to 24 months post treatment

• Time to Disease Progression (TTP)

  Up to 24 months post treatment

• Progression Free Survival (PFS)

  24 months post treatment

• Overall Survival (OS)

  24 months post treatment or until study closure

Study Arms (1)

Brentuximab Vedotin Treatment

EXPERIMENTAL

Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.

Drug: Brentuximab vedotin

Interventions

Brentuximab vedotin DRUG

Brentuximab vedotin will be given by intravenous infusion (into a vein) on Day 1 of every 21 day cycle.

Also known as: SGN-35, ADCETRISTM, antibody drug conjugate(ADC), chemotherapy, monomethyl auristatin E (MMAE)

Brentuximab Vedotin Treatment

Eligibility Criteria

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

You may qualify if:

• Confirmed diagnosis of PTCL expressing CD30 receptor. Following PTCL subtypes will be eligible: Peripheral T - cell lymphoma, not otherwise specified (NOS); Angioimmunoblastic T-cell Lymphoma; Subcutaneous Panniculitis Like T-cell Lymphoma; Hepatosplenic gamma/delta T cell Lymphoma; Extranodal natural killer (NK)T-cell Lymphoma, nasal type; Enteropathy-associated T-cell lymphoma; Adult T-cell Leukemia/lymphoma; T-cell prolymphocytic leukemia; Primary cutaneous gamma-delta T-cell lymphoma; Aggressive NK cell leukemia; Aggressive subtype of T cell Large Granular Lymphocytic (LGL) or transformed LGL leukemia; Epstein Barr Virus(EBV)-positive T-cell lymphoproliferative disorders of childhood; Transformed mycosis fungoides who have progressed following treatment with at least one systemic therapy; Sezary syndrome
• Histology slides and pathology material must be available at the site for each patient before enrollment in order to be sent to the Leading Institution of the study for central pathology review and pharmacodynamic studies.
• Patients must have progressive, relapsed or refractory disease after: At least one prior systemic anti-lymphoma regimen (chemotherapy or immunotherapy except for transformed mycosis fungoides as described previously); Relapsed or failed autologous or allogeneic stem cell transplant.
• Understand and voluntarily sign an Institutional Review Board (IRB) approved informed consent form
• Must have at least one site of disease (index lesion) measurable in two dimensions by computed tomography (CT)
• Patients with leukemic form of PTCL who will not have a measurable lesion in two dimensions by CT scan, relapsed or refractory disease must be detected by immunohistochemistry or flow cytometry and molecular clonality studies in bone marrow or peripheral blood.
• At least 2 weeks since the last chemotherapy, radiation therapy, immunotherapy or any investigational products
• Must meet the following criteria within 4 days before the first dose of study drug:
• Neutrophils ≥1,000/ul
• Hemoglobin ≥ 8 g/dL
• Platelets≥ 50.0x10\^9 /L
• Total bilirubin ≤ 1.5 x upper normal limit, or ≤ 5 x upper normal limit if documented hepatic involvement with lymphoma or history of Gilbert's Syndrome
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper normal limit (≤ 5 x upper normal limit if documented hepatic involvement with lymphoma)
• Calculated creatinine clearance ≥ 40 mL/min/1.73 m\^2 based on Cockcroft and Gault method
• PT or International Normalization Ratio (INR), and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 x upper limit of normal unless patient is receiving anticoagulants. If patient is on anticoagulation therapy, levels should be within therapeutic range.

You may not qualify if:

• Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug: Myocardial infarction and the New York Heart Association (NYHA) Class III or IV heart failure
• History of another primary malignancy not in clinical remission; except adequately treated patients with completely resected in situ carcinoma, such as nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, or localized prostate cancer with prostate-specific antigen (PSA) \<1 ng/ml
• Known active cerebral/meningeal involvement with lymphoma. Asymptomatic patients with previously treated and resolved central nervous system (CNS) lymphoma involvement are permitted.
• Prior administration of Brentuximab vedotin
• Corticosteroid monotherapy for lymphoma within 1 week of the first dose of study drug
• Any serious underlying medical condition that, in the opinion of the investigator or medical monitor, would impair the ability to receive or tolerate the planned treatment
• Known hypersensitivity to recombinant proteins, or any component contained in the drug formulation
• Female patients who are lactating or have a positive serum pregnancy test during the screening period

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Seagen Inc.: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Recurrence

Interventions

Brentuximab Vedotin; Immunoconjugates; Drug Therapy; monomethyl auristatin E

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutics

Limitations and Caveats

Planned accrual: 20. Sponsor withdrew support soon after one enrollment. Accrual was terminated; analysis unable to be performed. Participant stopped treatment after 14 cycles due to progressive lymphadenopathy; entered another clinical trial.

Results Point of Contact

• Title: Dr. Lubomir Sokol
• Organization: H. Lee Moffitt Cancer Center and Research Institute

lubomir.sokol@moffitt.org

813-745-8212

Study Officials

• Lubomir Sokol, M.D., Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: April 26, 2013
• Study Start: April 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 19, 2017
• Results First Posted: January 19, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)