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Trial record 77 of 881 for:    "Reticulum Cell Sarcoma"

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

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ClinicalTrials.gov Identifier: NCT03947255
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : October 8, 2019
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 classical 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)
Estimated Study Start Date : October 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 Lugano response criteria [ 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 Lugano response criteria [ Time Frame: Up to approximately 5 years ]
  2. Progression-free survival (PFS) per BICR according to Lugano response criteria [ 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 Lugano response criteria [ Time Frame: Up to approximately 1 year ]
  5. ORR per investigator assessment according to Lugano response criteria [ Time Frame: Up to approximately 1 year ]
  6. DOR per investigator assessment according to Lugano response criteria [ Time Frame: Up to approximately 5 years ]
  7. PFS per investigator assessment according to Lugano response criteria [ Time Frame: Up to approximately 5 years ]
  8. Rate of CR per investigator assessment according to Lugano response criteria [ Time Frame: Up to approximately 5 years ]


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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, 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         
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     History of Changes
Other Study ID Numbers: SGN35-028
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

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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