A Study of Brentuximab Vedotin in Relapsed or Refractory CD30-positive Non-Hodgkin Lymphoma - Full Text View

Purpose

This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Condition	Intervention	Phase
Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoma, T-Cell	Drug: brentuximab vedotin Drug: rituximab	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 2 Study of Brentuximab Vedotin in Relapsed or Refractory CD30-positive Non-Hodgkin Lymphoma (NHL)

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab Brentuximab vedotin

U.S. FDA Resources

Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:

Objective response rate with brentuximab vedotin [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
Incidence of adverse events with brentuximab vedotin + rituximab [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
Incidence of laboratory abnormalities with brentuximab vedotin + rituximab [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of adverse events with brentuximab vedotin [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
Incidence of laboratory abnormalities with brentuximab vedotin [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
Correlation between CD30 expression and antitumor activity with brentuximab vedotin [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: Until disease progression or study closure ] [ Designated as safety issue: No ]
Progression-free survival [ Time Frame: Until disease progression or study closure ] [ Designated as safety issue: No ]
Area under the plasma concentration versus time curve (AUC) [ Time Frame: Cycle 1: pre-dose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
Peak plasma concentration (Cmax) [ Time Frame: Cycle 1: pre-dose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
Plasma concentration at end of infusion (Ceoi) [ Time Frame: Cycle 1: pre-dose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
Pharmacodynamic (PD) biomarkers [ Time Frame: Pre-dose at each cycle ] [ Designated as safety issue: No ]
Objective response rate with brentuximab vedotin + rituximab [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
Complete remission (CR) rate [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]

Estimated Enrollment:	110
Study Start Date:	August 2011
Estimated Study Completion Date:	March 2016
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Brentuximab vedotin+rituximab	Drug: brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion Other Name: SGN-35 Drug: rituximab 375 mg/m2 every 3 weeks by IV infusion
Experimental: Brentuximab vedotin	Drug: brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion Other Name: SGN-35

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically-confirmed CD30-positive NHL
Relapsed or refractory disease following at least 1 prior systemic therapy
Measurable disease of at least 1.5 cm as documented by CT
ECOG performance status less than or equal to 2

Exclusion Criteria:

History of another primary invasive malignancy that has not been in remission for at least 3 years
Current diagnosis of systemic or cutaneous anaplastic large cell lymphoma or mycosis fungoides
B cell lymphoma previously treated with only single-agent rituximab (for patients receiving brentuximab vedotin only) or corticosteroids as monotherapy
Known cerebral/meningeal disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421667

Contacts

Contact: Terri Lowe

866-333-7436

clinicaltrials@seagen.com

Show 29 Study Locations

Sponsors and Collaborators

Seattle Genetics, Inc.

Investigators

Study Director:

Laurie Grove, PA-C

Seattle Genetics, Inc.

More Information

No publications provided

Responsible Party:	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT01421667 History of Changes
Other Study ID Numbers:	SGN35-012
Study First Received:	August 19, 2011
Last Updated:	May 1, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:

Lymphoma, Large B-Cell, Diffuse
Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
Lymphoma, Non-Hodgkin
Monomethyl auristatin E

Drug Therapy
Immunotherapy
Hematologic Diseases
Lymphoma
Lymphoma, B-Cell
Lymphoma, T-Cell

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders

Immune System Diseases
Antibodies, Monoclonal
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 21, 2013