Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

Seagen

Status and phase: Completed; Phase 2

Conditions: Acute Lymphoid Leukemia; Anemia, Refractory, With Excess of Blasts; Solid Tumors; Acute Myeloid Leukemia

Treatments: Drug: brentuximab vedotin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01461538

SGN35-013

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 3 patient groups

Brentuximab vedotin 1.8 mg/kg

Experimental group

Description:

Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion

Treatment:

Drug: brentuximab vedotin

Drug: brentuximab vedotin

Drug: brentuximab vedotin

Brentuximab vedotin 2.4 mg/kg

Experimental group

Description:

Brentuximab vedotin 2.4 mg/kg every 3 weeks by IV infusion

Treatment:

Drug: brentuximab vedotin

Drug: brentuximab vedotin

Drug: brentuximab vedotin

Brentuximab vedotin 1.2 mg/kg

Experimental group

Description:

Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by IV infusion

Treatment:

Drug: brentuximab vedotin

Drug: brentuximab vedotin

Drug: brentuximab vedotin