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OpenTrials
Completed

NCT Number: NCT01874054

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

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.

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Key information

Conditions

Hodgkin Disease Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brentuximab Vedotin

Drug

1.8 mg/kg every 3 weeks by intravenous (IV) infusion

Other names: Adcetris; SGN-35

Bendamustine

Drug

90 mg/m2 on Days 1 and 2 of 3-week cycles

Primary outcomes

  1. Complete Remission Rate

    Time frame: Up to 4.6 months

    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.

  2. Incidence of Adverse Events (AEs)

    Time frame: Up to 13.8 months

    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.

Secondary outcomes

  1. Incidence of Dose-limiting Toxicities

    Time frame: Up to 3 weeks; first cycle of therapy through the first day of Cycle 2

    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.

  2. Overall Best Response Rate

    Time frame: Up to 4.6 months

    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

  3. Duration of Response

    Time frame: Up to 47.8 months

    The time from first observation of remission to disease progression/relapse or death from any cause, whichever occurs first.

  4. Progression-free Survival

    Time frame: Up to 49 months

    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.

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2015
Study completion
2018
First posted
Jun 10, 2013
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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