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

Phase 2
6 Years
Open (Enrolling)
Acute Lymphoid Leukemia, Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Multiple Myeloma, Solid Tumors

Thank you

Trial Information

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (ORR)

Outcome Time Frame:

Through 1 month following last dose

Safety Issue:


Principal Investigator

Tina Albertson, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

October 2011

Completion Date:

February 2014

Related Keywords:

  • Acute Lymphoid Leukemia
  • Acute Myeloid Leukemia
  • Chronic Lymphocytic Leukemia
  • Multiple Myeloma
  • Solid Tumors
  • Acute Lymphoid Leukemia
  • Chronic Lymphocytic Leukemia
  • Acute Myeloid Leukemia
  • Multiple Myeloma
  • Solid Tumors
  • Antibodies, Monoclonal
  • Antibody-Drug Conjugate
  • Antigens, CD30
  • Drug Therapy
  • Hematologic Diseases
  • Immunotherapy
  • Monomethyl Auristatin E
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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