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Completed

NCT Number: NCT01461538

Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.

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Key information

Conditions

Acute Lymphoid Leukemia Acute Myeloid Leukemia Anemia Anemia, Refractory Anemia, Refractory, With Excess of Blasts Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Solid Tumors

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy
  • Have failed, refused, or have been deemed ineligible for standard therapy
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70

Exclusion criteria

  • Primary diagnosis of lymphoma or central nervous system (CNS) malignancy
  • History of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years
  • Evidence of active cerebral/meningeal disease

Treatment and study plan

Brentuximab Vedotin

Drug

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

Other names: Adcetris; SGN-35

Primary outcomes

  1. Objective Response Rate (ORR) by Investigator

    Time frame: Up to approximately 3 years

    Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).

Secondary outcomes

  1. Complete Remission (CR) Rate by Investigator

    Time frame: Up to approximately 3 years

    Percentage of participants who achieved a best response of CR per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).

  2. Duration of Objective Response by Kaplan-Meier Analysis

    Time frame: Up to approximately 2 years

    Duration of objective response (CR [+CRi; leukemia] + PR), defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).

  3. Duration of Complete Response by Kaplan-Meier Analysis

    Time frame: Up to approximately 2 years

    Duration of CR, defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).

  4. Progression-Free Survival by Kaplan-Meier Analysis

    Time frame: Up to approximately 2 years

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

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

    Time frame: Up to approximately 3 years

    Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-013). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). 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.

  6. Laboratory Abnormalities >/= Grade 3

    Time frame: Up to approximately 3 years

    Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 4.03. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category

  7. Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi)

    Time frame: Up to approximately 3 years

  8. Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough)

    Time frame: Up to approximately 3 years

  9. Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)

    Time frame: Up to approximately 3 years

  10. Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough)

    Time frame: Up to approximately 3 years

  11. Incidence of Anti-therapeutic Antibodies (ATA)

    Time frame: Up to approximately 3 years

    Counts of participants with post-baseline anti-brentuximab vedotin antibodies. Persistently positive is defined as confirmed ATA in more than 2 post-baseline samples and transiently positive is defined as confirmed ATA in 1 or 2 post-baseline samples.

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Registry information

Official study title

A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 28, 2011
Registry last updated
Mar 4, 2016

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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