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

• Sponsor: Seagen Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03947255
• Collaborator: (none)

Study Details

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
• Anticipated 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: Oct 28, 2019
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 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) [Up to approximately 1 year]

2. Number of participants with adverse events [Up to approximately 5 years]

3. Number of participants with laboratory abnormalities [Up to approximately 1 year]

Secondary Outcome Measures

1. Duration of response (DOR) per BICR according to modified Lugano response criteria (Cheson 2014) [Up to approximately 5 years]

2. Progression-free survival (PFS) per BICR according to modified Lugano response criteria (Cheson 2014) [Up to approximately 5 years]

3. Overall survival (OS) [Up to approximately 5 years]

4. Rate of complete response (CR) per BICR according to modified Lugano response criteria [Up to approximately 1 year]

5. ORR per investigator assessment according to modified Lugano response criteria (Cheson 2014) [Up to approximately 1 year]

6. DOR per investigator assessment according to modified Lugano response criteria (Cheson 2014) [Up to approximately 5 years]

7. PFS per investigator assessment according to modified Lugano response criteria (Cheson 2014) [Up to approximately 5 years]

8. Rate of CR per investigator assessment according to modified Lugano response criteria (Cheson 2014) [Up to approximately 5 years]

9. ORR per BICR according to Lugano response criteria (Cheson 2014) [Up to approximately 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Pacific Cancer Medical Center	Anaheim	California	United States	92801
2	SCL Health Good Samaritan Medical Center Cancer Centers of Colorado	Lafayette	Colorado	United States	80026
3	Memorial Cancer Institute	Pembroke Pines	Florida	United States	33028
4	Northwest Oncology and Hematology/AMITA	Elk Grove Village	Illinois	United States	60007
5	Cardinal Bernardin Cancer Center / Loyola University Medical Center	Maywood	Illinois	United States	60153
6	Norton Cancer Institute	Louisville	Kentucky	United States	40207
7	Tulane University Hospital and Clinic	New Orleans	Louisiana	United States	70112
8	University of Maryland	Baltimore	Maryland	United States	21201
9	Karmanos Cancer Institute / Wayne State University	Detroit	Michigan	United States	48201
10	Saint Louis University	Saint Louis	Missouri	United States	63103
11	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89169
12	Summit Medical Group	Florham Park	New Jersey	United States	07932
13	Medical University of South Carolina/Hollings Cancer Center	Charleston	South Carolina	United States	29425
14	Texas Oncology - Fort Worth	Dallas	Texas	United States	75246
15	Texas Oncology - Fort Worth 12th Avenue	Fort Worth	Texas	United States	76104
16	The Center for Cancer and Blood Disorders: Fortworth	Fort Worth	Texas	United States	76104
17	MD Anderson Cancer Center / University of Texas	Houston	Texas	United States	77030-4095
18	Houston Methodist Cancer Center	Houston	Texas	United States	77030
19	Texas Oncology - San Antonio Medical Center	San Antonio	Texas	United States	78240

Sponsors and Collaborators

• Seagen Inc.

Investigators

• Study Director: Dominic Lai, MD, Seagen Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seagen Inc.
• ClinicalTrials.gov Identifier: NCT03947255
• Other Study ID Numbers: SGN35-028
• First Posted: May 13, 2019
• Last Update Posted: Nov 23, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Seagen Inc.: CD30-expression; sALCL; PTCL; cHL; Seattle Genetics
• Additional relevant MeSH terms: Lymphoma; Hodgkin Disease; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Large-Cell, Anaplastic; Brentuximab Vedotin

Study Results

No Results Posted as of Nov 23, 2021