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Completed

NCT Number: NCT00848926

A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma

This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma.

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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 Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UZ Gasthuisberg, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with relapsed or refractory Hodgkin lymphoma who have previously received autologous stem cell transplant.
  • Histologically confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block.
  • Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm as documented by spiral computed tomography.
  • At US sites patients greater than or equal to 12 years of age may be enrolled. At non-US sites patients must be greater than or equal to 18 years of age.

Exclusion criteria

  • Previous treatment with brentuximab vedotin.
  • Previously received an allogeneic transplant.
  • Congestive heart failure, Class III or IV, by the New York Heart Association criteria.
  • History of another primary malignancy that has not been in remission for at least 3 years.
  • Known cerebral/meningeal disease.

Treatment and study plan

Brentuximab Vedotin

Drug

1.8 mg/kg every 3 weeks by intravenous infusion

Other names: SGN-35, ADCETRIS

Primary outcomes

  1. Objective Response Rate by Independent Review Group

    Time frame: up to 12 months

    Percentage of participants 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.

Secondary outcomes

  1. Complete Remission Rate by Independent Review Group

    Time frame: up to 12 months

    Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

  2. Duration of Objective Response by Kaplan-Meier Analysis

    Time frame: up to approximately 4 years

    Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.

  3. Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis

    Time frame: up to approximately 4 years

    Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.

  4. Progression-free Survival by Kaplan-Meier Analysis

    Time frame: up to approximately 4 years

    Time from start of study treatment to disease progression per independent review group or death due to any cause.

  5. Overall Survival

    Time frame: up to approximately 6 years

    Time from start of study treatment to date of death due to any cause.

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

    Time frame: up to 12 months

    Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). 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.

  7. Hematology Laboratory Abnormalities >/= Grade 3

    Time frame: up to 12 months

    Counts of study participants with post-baseline hematology 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.

  8. Chemistry Laboratory Abnormalities >/= Grade 3

    Time frame: up to 12 months

    Counts of study participants with post-baseline chemistry 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.

  9. Area Under the Curve

    Time frame: 3 weeks

    Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin

  10. Maximum Serum Concentration

    Time frame: 3 weeks

    Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin

  11. Time of Maximum Serum Concentration

    Time frame: 3 weeks

    Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin

Other outcomes

  1. B Symptom Resolution

    Time frame: up to 12 months

    Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Collaborators

  • Millennium Pharmaceuticals, Inc.

Registry information

Official study title

A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

Important dates

Study start
2009
Primary completion
2010
Study completion
2015
First posted
Feb 20, 2009
Registry last updated
Mar 13, 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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