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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
| 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:
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Outcome Measures
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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 ]
Eligibility Criteria
| 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
| Contact: Seagen Trial Information Support | 866-333-7436 | clinicaltrials@seagen.com |
Locations
Show 18 study locations
Sponsors and Collaborators
Seagen Inc.
Investigators
| 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 |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| 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 |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: brentuximab vedotin
1.8 mg/kg given intravenously (IV)
Other Names:
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| Study Arms ICMJE | Experimental: Brentuximab vedotin
Intervention: Drug: brentuximab vedotin
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
80 | ||||
| Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| 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 |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Seagen Inc. | ||||
| Study Sponsor ICMJE | Seagen Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Seagen Inc. | ||||
| Verification Date | May 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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