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A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03947255
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
This study will look at whether brentuximab vedotin works and is safe in the re-treatment setting. To be in this study, patients must have already received brentuximab vedotin as treatment and have cancer that progressed (got worse) after stopping treatment.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Peripheral T Cell Lymphoma Anaplastic Large Cell Lymphoma Drug: brentuximab vedotin Phase 2

Detailed Description:
This is a study to determine the safety and efficacy of brentuximab vedotin in subjects with classic Hodgkin lymphoma (cHL) and systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T cell lymphoma (PTCL) who experienced complete response (CR) or partial response (PR) with a brentuximab vedotin-containing regimen and subsequently experienced disease progression or relapse.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Single-arm Study of Retreatment With Brentuximab Vedotin in Subjects With Relapsed or Refractory Classic Hodgkin Lymphoma (cHL) or CD30-expressing Peripheral T Cell Lymphoma (PTCL)
Actual Study Start Date : October 28, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024


Arm Intervention/treatment
Experimental: Brentuximab vedotin Drug: brentuximab vedotin
1.8 mg/kg given intravenously (IV)
Other Names:
  • ADCETRIS
  • SGN-35




Primary Outcome Measures :
  1. Objective response rate (ORR) per BICR according to modified Lugano response criteria (Cheson 2014) [ Time Frame: Up to approximately 1 year ]
  2. Number of participants with adverse events [ Time Frame: Up to approximately 5 years ]
  3. Number of participants with laboratory abnormalities [ Time Frame: Up to approximately 1 year ]

Secondary Outcome Measures :
  1. Duration of response (DOR) per BICR according to modified Lugano response criteria (Cheson 2014) [ Time Frame: Up to approximately 5 years ]
  2. Progression-free survival (PFS) per BICR according to modified Lugano response criteria (Cheson 2014) [ Time Frame: Up to approximately 5 years ]
  3. Overall survival (OS) [ Time Frame: Up to approximately 5 years ]
  4. Rate of complete response (CR) per BICR according to modified Lugano response criteria [ Time Frame: Up to approximately 1 year ]
  5. ORR per investigator assessment according to modified Lugano response criteria (Cheson 2014) [ Time Frame: Up to approximately 1 year ]
  6. DOR per investigator assessment according to modified Lugano response criteria (Cheson 2014) [ Time Frame: Up to approximately 5 years ]
  7. PFS per investigator assessment according to modified Lugano response criteria (Cheson 2014) [ Time Frame: Up to approximately 5 years ]
  8. Rate of CR per investigator assessment according to modified Lugano response criteria (Cheson 2014) [ Time Frame: Up to approximately 5 years ]
  9. ORR per BICR according to Lugano response criteria (Cheson 2014) [ Time Frame: Up to approximately 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL
  • Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or relapse after discontinuing treatment
  • Documentation of disease relapse or progression ≥6 months after the last dose of brentuximab vedotin
  • Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional measurable disease of at least 1.5 cm in longest axis as documented by radiographic technique
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
  • Must not be pregnant and, if of childbearing or fathering potential, must agree to use 2 effective contraception methods during study and for 6 months following last dose of study drug

Exclusion Criteria:

  • Previously discontinued brentuximab vedotin due to any Grade 3 or higher toxicity
  • Existing Grade 2 or higher peripheral neuropathy
  • Previously refractory to treatment with brentuximab vedotin
  • History of a cerebral vascular event, unstable angina, or myocardial infarction within 6 months prior to first dose
  • History of another malignancy within 3 years before first dose of study drug or any evidence of residual disease from previously diagnosed malignancy
  • Acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against GvHD
  • Active cerebral/meningeal disease
  • History of progressive multifocal leukoencephalopathy (PML)
  • Active uncontrolled Grade 3 (per NCI CTCAE v5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to first dose of study drug
  • Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03947255


Contacts
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Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
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United States, California
Pacific Cancer Medical Center Recruiting
Anaheim, California, United States, 92801
Contact: Elizabeth Brown    714-999-1465    elizabethg@pacificcancer.com   
Principal Investigator: Veena Charu         
United States, Florida
Memorial Cancer Institute Recruiting
Pembroke Pines, Florida, United States, 33028
Contact: Nicole Procaccini    954-265-4325    NProcaccini@mhs.net   
Principal Investigator: Jose Sandoval-Sus, MD         
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40202
Contact: Heather Woolridge    502-899-3366    Heather.woolridge@nortonhealthcare.org   
Principal Investigator: Don Stevens, MD         
United States, Louisiana
Tulane University Hospital and Clinic Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Gaynelle Davis    504-988-6770    gdavis7@tulane.edu   
Principal Investigator: Nakhle Saba, MD         
United States, Michigan
Karmanos Cancer Institute / Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Carly Malburg    313-576-8711    malburgc@karmanos.org   
Contact: Mary Domagalski    313-576-8711    domagalm@karmanos.org   
Principal Investigator: Erlene Seymour, MD         
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Meng-Yun (Megan) Wu    702-952-3400    megan.wu@usoncology.com   
Principal Investigator: Edwin Kingsley, MD         
United States, New Jersey
Summit Medical Group Recruiting
Florham Park, New Jersey, United States, 07932
Contact: Michelle Mackenzie    973-436-1755    mmackenzie@smgnj.com   
Principal Investigator: Benjamin Freeman, MD         
United States, Texas
The Center for Cancer and Blood Disorders: Fortworth Recruiting
Fort Worth, Texas, United States, 76104
Contact: Brandi Halstead    817-759-7013    bhalstead@txcc.com   
Principal Investigator: Ray Page, MD         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
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Study Director: Julie Lisano, PharmD Seattle Genetics, Inc.

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Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT03947255    
Other Study ID Numbers: SGN35-028
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 25, 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seattle Genetics, Inc.:
CD30-expression
sALCL
PTCL
cHL
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs