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A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma

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Seagen

Status and phase

Completed
Phase 2

Conditions

Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin

Treatments

Drug: brentuximab vedotin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00866047
SG035-0004
2008-006035-12 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

58 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with relapsed or refractory systemic ALCL who have previously received front line chemotherapy.
  • Documented anaplastic lymphoma kinase (ALK) status.
  • 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 and measurable disease of at least 1.5 cm as documented by both positron emission tomography and spiral computed tomography.
  • Received any previous autologous stem cell transplant at least 12 weeks (3 months) prior.
  • 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.
  • Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).
  • Known cerebral/meningeal disease.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

58 participants in 1 patient group

Brentuximab vedotin
Experimental group
Description:
Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Treatment:
Drug: brentuximab vedotin

Trial contacts and locations

22

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Data sourced from clinicaltrials.gov

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