Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma

Hodgkin Disease Clinical Trial

Official title:

A Phase 1/2 Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin in Combination With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874054
• Other study ID #: SGN35-016
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2013
• Est. completion date: February 20, 2018

Study information

• Verified date: January 2019
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess safety and efficacy of brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory Hodgkin lymphoma. It is an open-label, 2-stage study designed to determine the recommended dose level of bendamustine in combination with brentuximab vedotin. The study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 20, 2018
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histopathological diagnosis of classical Hodgkin lymphoma

• Failed standard front-line therapy

• Measurable disease of at least 1.5 cm as documented by radiographic technique

• Eastern Cooperative Oncology Group performance status less than or equal to 2

Exclusion Criteria:

• Received prior salvage therapy, including radiotherapy

• Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug

• Concurrent use of other investigational agents

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

Intervention

Drug:
• brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
• bendamustine
90 mg/m2 on Days 1 and 2 of 3-week cycles

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Jewish Hospital, The	Cincinnati	Ohio
United States	Case Western Reserve University / University Hospitals Case Medical Center	Cleveland	Ohio
United States	Charles A. Sammons Cancer Center / Baylor University Medical Center	Dallas	Texas
United States	Colorado Blood Cancer Institute	Denver	Colorado
United States	Saint Francis Hospital / Bon Secours	Greenville	South Carolina
United States	Columbia University Medical Center	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Mayo Clinic Minnesota	Rochester	Minnesota
United States	Pacific Hematology Oncology Associates	San Francisco	California
United States	Stanford Cancer Center	Stanford	California
United States	Oncology Institute of Hope & Innovation, The	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Remission Rate	Complete remission rate among all subjects (Phase 1 and 2 combined) treated at the dose level selected for Phase 2. Complete remission (CR) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma is a disappearance of all evidence of disease.	Up to 4.6 months
Primary	Incidence of Adverse Events (AEs)	All AEs reported after initiation of treatment and pre-existing conditions that worsen after initiation of treatment will be considered treatment-emergent AEs (TEAEs). All AEs will be coded by system organ class, MedDRA preferred term, and severity grade using NCI CTCAE V4.03. All recorded AEs will be included in the data listings.	Up to 13.8 months
Secondary	Incidence of Dose-limiting Toxicities	Incidence of dose-limiting toxicity (DLT) was evaluated in an initial safety cohort of 10 patients who were followed for protocol-defined DLT events until Cycle 2 Day 1.	Up to 3 weeks; first cycle of therapy through the first day of Cycle 2
Secondary	Overall Best Response Rate	Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), stable disease (SD, failure to obtain a complete or partial response or progressive disease), or progressive disease (PD, any new lesion or increase by 50% or more of previously involved sites from nadir) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma	Up to 4.6 months
Secondary	Duration of Response	The time from first observation of remission to disease progression/relapse or death from any cause, whichever occurs first.	Up to 47.8 months
Secondary	Progression-free Survival	The time from first dose of study medication to first documentation of disease progression/relapse, or to death due to any cause, whichever occurs first.	Up to 49 months