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出境医 / 临床实验 / A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma

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

Study Description
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
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
Arms and Interventions
Arm Intervention/treatment
Experimental: Brentuximab vedotin Drug: brentuximab vedotin
1.8 mg/kg given intravenously (IV)
Other Names:
  • ADCETRIS
  • SGN-35
Outcome Measures
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 ]

Eligibility Criteria
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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
Contacts and Locations

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

Locations
Show Show 18 study locations
Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Dominic Lai, MD Seagen Inc.
Tracking Information
First Submitted Date  ICMJE May 9, 2019
First Posted Date  ICMJE May 13, 2019
Last Update Posted Date June 1, 2021
Actual Study Start Date  ICMJE October 28, 2019
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2019)
  • Objective response rate (ORR) per BICR according to modified Lugano response criteria (Cheson 2014) [ Time Frame: Up to approximately 1 year ]
  • Number of participants with adverse events [ Time Frame: Up to approximately 5 years ]
  • Number of participants with laboratory abnormalities [ Time Frame: Up to approximately 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Objective response rate (ORR) per BICR according to Lugano response criteria [ Time Frame: Up to approximately 1 year ]
  • Number of participants with adverse events [ Time Frame: Up to approximately 5 years ]
  • Number of participants with laboratory abnormalities [ Time Frame: Up to approximately 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2019)
  • Duration of response (DOR) per BICR according to modified Lugano response criteria (Cheson 2014) [ Time Frame: Up to approximately 5 years ]
  • Progression-free survival (PFS) per BICR according to modified Lugano response criteria (Cheson 2014) [ Time Frame: Up to approximately 5 years ]
  • Overall survival (OS) [ Time Frame: Up to approximately 5 years ]
  • Rate of complete response (CR) per BICR according to modified Lugano response criteria [ Time Frame: Up to approximately 1 year ]
  • ORR per investigator assessment according to modified Lugano response criteria (Cheson 2014) [ Time Frame: Up to approximately 1 year ]
  • DOR per investigator assessment according to modified Lugano response criteria (Cheson 2014) [ Time Frame: Up to approximately 5 years ]
  • PFS per investigator assessment according to modified Lugano response criteria (Cheson 2014) [ Time Frame: Up to approximately 5 years ]
  • Rate of CR per investigator assessment according to modified Lugano response criteria (Cheson 2014) [ Time Frame: Up to approximately 5 years ]
  • ORR per BICR according to Lugano response criteria (Cheson 2014) [ Time Frame: Up to approximately 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Duration of response (DOR) per BICR according to Lugano response criteria [ Time Frame: Up to approximately 5 years ]
  • Progression-free survival (PFS) per BICR according to Lugano response criteria [ Time Frame: Up to approximately 5 years ]
  • Overall survival (OS) [ Time Frame: Up to approximately 5 years ]
  • Rate of complete response (CR) per BICR according to Lugano response criteria [ Time Frame: Up to approximately 1 year ]
  • ORR per investigator assessment according to Lugano response criteria [ Time Frame: Up to approximately 1 year ]
  • DOR per investigator assessment according to Lugano response criteria [ Time Frame: Up to approximately 5 years ]
  • PFS per investigator assessment according to Lugano response criteria [ Time Frame: Up to approximately 5 years ]
  • Rate of CR per investigator assessment according to Lugano response criteria [ Time Frame: Up to approximately 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma
Official Title  ICMJE 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)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hodgkin Lymphoma
  • Peripheral T Cell Lymphoma
  • Anaplastic Large Cell Lymphoma
Intervention  ICMJE Drug: brentuximab vedotin
1.8 mg/kg given intravenously (IV)
Other Names:
  • ADCETRIS
  • SGN-35
Study Arms  ICMJE Experimental: Brentuximab vedotin
Intervention: Drug: brentuximab vedotin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 16, 2019) 		80
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2019) 		50
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Seagen Trial Information Support 866-333-7436 clinicaltrials@seagen.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03947255
Other Study ID Numbers  ICMJE SGN35-028
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seagen Inc.
Study Sponsor  ICMJE Seagen Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dominic Lai, MD Seagen Inc.
PRS Account Seagen Inc.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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