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NCT Number: NCT00947856

A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study

This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab vedotin study.

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Key information

Conditions

Disease, Hodgkin Hematologic Diseases Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hopital Saint-Louis/Service d'Hematologie, Paris, Cedex 10, France

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About this study

This is a multicenter, open-label study to evaluate single-agent brentuximab vedotin (SGN-35) treatment in patients who previously participated in a brentuximab vedotin study, including Studies SGN35-005 (NCT01100502), SGN35-007 (NCT01026233), and SGN35-008 (NCT01026415). Patients treated on this study (SGN35-006) could re-enroll on study if eligible. The study consisted of 2 arms, as follows:

  • Retreatment arm: Patients with CD30-positive hematologic malignancies who experienced a complete remission (CR) or partial remission (PR) with previous brentuximab vedotin treatment on a clinical study and subsequently experienced disease progression or relapse. The purpose of this arm was to assess safety and efficacy of retreatment with brentuximab vedotin.
  • Extension treatment arm: Patients with either CD30-positive hematologic or nonhematologic malignancies who completed treatment in a prior brentuximab vedotin study without unacceptable toxicity and experienced clinical benefit as assessed by the investigator. The purpose of this arm was to enable patients who participated in certain prior brentuximab vedotin trials to receive extension treatment and to assess patient safety and survival in the extension treatment setting.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participated in a previous brentuximab vedotin study.
  • CD30-positive hematologic malignancy.
  • At a minimum, experienced clinical benefit in the prior brentuximab vedotin study. For retreatment, patients must have previously achieved either complete or partial remission with brentuximab vedotin and experienced disease progression after discontinuing the prior brentuximab vedotin study.

Exclusion criteria

Withdrew consent to participate in any prior brentuximab vedotin study.

Treatment and study plan

Brentuximab Vedotin

Drug

Every 3 weeks by IV infusion (1.2 or 1.8 mg/kg) until disease progression, unacceptable toxicity, or study closure

Other names: Adcetris

Primary outcomes

  1. Objective Response Rate by Investigator

    Time frame: Up to approximately 38 months

    Percentage of participants in the retreatment arm who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

  2. Adverse Events by Severity, Seriousness, and Relationship to Treatment

    Time frame: up to 39 months

    Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on SGN35-006). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.

  3. Laboratory Abnormalities >/= Grade 3

    Time frame: Up to 39 months

    Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.

Secondary outcomes

  1. Duration of Objective Response by Kaplan-Meier Analysis

    Time frame: Up to 38 months

    Duration of objective response (CR + PR) on retreatment, defined as time of initial response until disease progression or death

  2. Progression-free Survival by Kaplan-Meier Analysis

    Time frame: Up to approximately 29 months

    Progression-free survival, defined as time from start of study treatment in the retreatment arm to disease progression per investigator or death due to any cause

  3. Overall Survival

    Time frame: Up to approximately 41 months

    Overall survival for both extension and retreatment arms, defined as time from start of study treatment to date of death due to any cause

  4. Incidence of Antitherapeutic Antibodies

    Time frame: Up to 39 months

    Counts of participants with anti-brentuximab vedotin antibodies at any time during extension treatment on Study SGN35-006 or number of retreatment experiences with anti-brentuximab vedotin antibodies at any time during retreatment

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Collaborators

  • Millennium Pharmaceuticals, Inc.

Registry information

Official study title

Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jul 28, 2009
Registry last updated
Feb 2, 2017

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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