NCT01620229

Brentuximab Vedotin After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Maintenance Therapy With Brentuximab Vedotin (SGN-35) After Allogeneic Hematopoietic Cell Transplantation for Hodgkin Lymphoma and CD30+ Hematologic Malignancies

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best way to give brentuximab vedotin and to see how well it works after donor stem cell transplant in treating patients with hematologic malignancies. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Monoclonal antibodies may kill cancer cells that are left after donor stem cell transplant.

Detailed description

PRIMARY OBJECTIVES: I. To determine the incidence of durable donor hematopoietic engraftment (defined by donor T-cell chimerism \> 50% at day +84 after hematopoietic cell transplantation \[HCT\]) after allogeneic HCT and post-transplant brentuximab vedotin. SECONDARY OBJECTIVES: I. Rates of complete and partial response; incidence of acute graft-versus-host disease (GVHD) grades II-IV and chronic GVHD; overall and progression-free survival; rates of serious adverse events associated with brentuximab vedotin. OUTLINE: Patients receive brentuximab vedotin intravenously (IV) on day 1. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 5 years.

Conditions

• Hematopoietic/Lymphoid Cancer

Interventions

Type	Name	Description
DRUG	brentuximab vedotin	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-04-01
• First posted: 2012-06-15
• Last updated: 2014-04-21

Locations

1 site across 1 country: United States