A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)
- Conditions
- Hodgkin DiseasePeripheral T Cell Lymphoma
- Interventions
- Registration Number
- NCT01716806
- Lead Sponsor
- Seagen Inc.
- Brief Summary
This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.
- Detailed Description
This study is designed to evaluate the efficacy and tolerability of brentuximab vedotin as monotherapy and in combination with other agents as frontline therapy. There are 6 parts of the study. The population to be studied includes treatment-naïve patients with classical Hodgkin lymphoma (HL) or treatment-naïve patients with CD30-expressing peripheral T-cell lymphoma (PTCL).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
-
Parts A, B, C, and D: 60 years of age or older
-
Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
-
Treatment-naive patients with CD30-expressing PTCL (Part F)
-
Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
-
Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E) or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by:
- A CIRS score of 10 or greater
- Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs)
-
Measurable disease of at least 1.5 cm as documented by radiographic technique
-
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D)
-
Symptomatic neurologic disease compromising IADLs or requiring medication
-
History of progressive multifocal leukoencephalopathy
-
Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin
-
Concurrent use of other investigational agents
-
Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
-
History of another malignancy within 1 year before first dose of study drug (Parts E and F only)
-
Part D only:
- Received any prior immune-oncology therapy
- History of known or suspected autoimmune disease
- Prior allogeneic stem cell transplant
- History of cerebral vascular event within 6 months of first dose of study drug
- Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicology
- Known history of pancreatitis
-
Parts D, E, and F only:
- Known cerebral/meningeal disease related to the underlying malignancy
- Systemic treatment with corticosteroids or other immunosuppressive medications within 1 week of enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part C: Brentuximab Vedotin + Bendamustine in HL Patients brentuximab vedotin - Part C: Brentuximab Vedotin + Bendamustine in HL Patients bendamustine - Part D: Brentuximab Vedotin + Nivolumab in HL Patients brentuximab vedotin - Part F: Brentuximab Vedotin in PTCL Patients brentuximab vedotin - Part B: Brentuximab Vedotin + Dacarbazine in HL Patients dacarbazine - Part B: Brentuximab Vedotin + Dacarbazine in HL Patients brentuximab vedotin - Part A: Brentuximab Vedotin in HL Patients brentuximab vedotin - Part D: Brentuximab Vedotin + Nivolumab in HL Patients nivolumab - Part E: Brentuximab Vedotin in HL Patients brentuximab vedotin -
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C) Up to 81 months Objective response rate (ORR) per investigator was defined as the percentage of subjects with complete response (CR) or partial response (PR) through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts A, B, and C the response was assessed using the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
ORR According to the Lugano Classification Revised Staging System for Nodal Non-Hodgkin and Hodgkin Lymphomas (Lugano Criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D) Up to 60 months Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Part D, the response was assessed using the Lugano Classification Revised Staging System for nodal non-Hodgkin and cHL (Lugano criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC).
ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F) Up to 31 months Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts E and F, the response was assessed per blinded independent central review (BICR) using the modified Lugano criteria.
- Secondary Outcome Measures
Name Time Method Disease Control Rate Up to 81 months Disease control rate (DCR) per investigator was defined as the percentage of subjects with CR, PR, or SD, per investigator assessment of best clinical response per Cheson 2007. For Parts E and F, the assessment was per BICR.
ORR According to Lugano Criteria Per BICR (Parts E and F) Up to 31 months Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment.
Number of Participants With Adverse Events Up to 122 months A treatment-emergent AE (TEAE) is defined as a newly occurring or worsening AE after the first dose of any study drug component. Treatment-related AEs are defined as treatment-emergent AEs that are determined by the investigator to be related to the treatment on study. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE.
Number of Participants With Laboratory Abnormalities Up to 30 months Laboratory values were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE.
Complete Response Rate Up to 81 months Complete response rate is defined as the percentage of patients with CR
Duration of Complete Response Up to 81 months Duration of CR per investigator was defined as the time from start of the first documentation of CR to the first documentation of tumor progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
Duration of Objective Response Up to 81 months Duration of response per investigator was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (PD) based on radiographic evidence of progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
Progression-free Survival Up to 83 months Progression-free survival (PFS) per investigator was defined as the time from start of study treatment to first documentation of tumor progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
B Symptom Resolution Rate Up to 42 weeks B symptom resolution rate per investigator was defined as the percentage of subjects with lymphoma-related B symptoms at baseline who achieved resolution of all B symptoms at any time during the treatment period.
Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA) Up to 30 months Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only) Up to 30 months Overall Survival (Parts E and F Only) Up to 44 months Overall survival (OS) per investigator was defined as the time from date of enrollment to date of death due to any cause.
Trial Locations
- Locations (54)
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
James Cancer Hospital / Ohio State University
🇺🇸Columbus, Ohio, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
MD Anderson Cancer Center / University of Texas
🇺🇸Houston, Texas, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Rocky Mountain Cancer Centers - Aurora
🇺🇸Aurora, Colorado, United States
Morristown Medical Center/ Carol G. Simon Cancer Center
🇺🇸Morristown, New Jersey, United States
Houston Methodist Cancer Center
🇺🇸Houston, Texas, United States
Virginia Cancer Specialists, PC
🇺🇸Fairfax, Virginia, United States
American Oncology Networks LLC
🇺🇸Bethesda, Maryland, United States
Wilshire Oncology Medical Group Inc.
🇺🇸Pomona, California, United States
University of Alberta / Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Texas Oncology - Denton South
🇺🇸Denton, Texas, United States
Providence St Joseph Medical Center
🇺🇸Burbank, California, United States
Georgia Cancer Specialists / Northside Hospital Cancer Institute
🇺🇸Sandy Springs, Georgia, United States
CIUSSS de L'Est de l'lle de Montreal / installation Hopital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
Arlington Cancer Center
🇺🇸Arlington, Texas, United States
Florida Cancer Affiliates
🇺🇸Trinity, Florida, United States
Karmanos Cancer Institute / Wayne State University
🇺🇸Detroit, Michigan, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
University of South Alabama - Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
Highlands Oncology Group
🇺🇸Springdale, Arkansas, United States
London Health Sciences Centre - Victoria Hospital
🇨🇦London, Ontario, Canada
Arizona Cancer Center / University of Arizona
🇺🇸Tucson, Arizona, United States
Texas Oncology - Seton Williamson
🇺🇸Round Rock, Texas, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Shenandoah Oncology P.C.
🇺🇸Winchester, Virginia, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Alaska Urological Institute
🇺🇸Anchorage, Alaska, United States
IACT Health
🇺🇸Columbus, Georgia, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Illinois Cancer Specialists / Advocate Lutheran General Hospital
🇺🇸Niles, Illinois, United States
Northwest Cancer Specialists, P.C.
🇺🇸Tigard, Oregon, United States
New York Oncology Hematology, P.C.
🇺🇸Albany, New York, United States
Minnesota Oncology Hematology P.A.
🇺🇸Minneapolis, Minnesota, United States
James P. Wilmot Cancer Center / University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Texas Oncology - Bedford
🇺🇸Bedford, Texas, United States
Texas Oncology - Fort Worth 12th Avenue
🇺🇸Fort Worth, Texas, United States
Texas Oncology - Longview
🇺🇸Longview, Texas, United States
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
🇺🇸Salem, Virginia, United States
Carbone Cancer Center / University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Benaroya Research Institute/Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Royal Victoria Hospital, McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Willamette Valley Cancer Institute and Research Center
🇺🇸Eugene, Oregon, United States
Arizona Oncology Associates, PC - HOPE
🇺🇸Tucson, Arizona, United States
Prisma Health
🇺🇸Greenville, South Carolina, United States
Texas Oncology - McAllen
🇺🇸McAllen, Texas, United States
Texas Oncology - Presbyterian Cancer Center Dallas
🇺🇸Dallas, Texas, United States