Brentuximab Vedotin in Treating Patients With Steroid-Resistant Acute Graft-Versus-Host Disease

NCT01616680 | Withdrawn Phase 2 DMC

• 2 other identifiers: 2589.00NCI-2012-00921
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to test the safety and efficacy of brentuximab vedotin in patients with acute skin graft-versus-host disease (GVHD)

Conditions

Graft Versus Host Disease

Outcome Measures

Primary Outcomes (1)

• Partial and complete response rates of steroid-resistant acute skin GVHD following administration of brentuximab vedotin

  Up to day 28

Secondary Outcomes (2)

• Complete and partial response rates of gut and liver acute GVHD after administration of brentuximab vedotin

  Up to day 28

• Incidence and severity of brentuximab vedotin-related toxicity after allogeneic HCT defined graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 4

  Assessed up to day 45

Study Arms (1)

Supportive care (brentuximab vedotin)

EXPERIMENTAL

Patients receive brentuximab vedotin IV over 30 minutes on days 1, 8, and 15.

Drug: brentuximab vedotin; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

brentuximab vedotin DRUG

Given IV

Also known as: Adcetris, anti-CD30 ADC SGN-35, anti-CD30 antibody-drug conjugate SGN-35, antibody-drug conjugate SGN-35, SGN-35

Supportive care (brentuximab vedotin)

laboratory biomarker analysis OTHER

Correlative studies

Supportive care (brentuximab vedotin)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Supportive care (brentuximab vedotin)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with steroid-resistant stage 2 or 3 acute GVHD of the skin with or without involvement of other organs; patients must have received initial therapy with prednisone or methylprednisolone at a prednisone-equivalent dose of at least 1.0 mg/kg/day alone or combined with other agents, including psoralen and ultraviolet A (PUVA), with:
• Flare of rash involving at least 25% of the body surface at any time after starting prednisone for GVHD treatment, OR
• Rash involving more than 50% of the body surface persisting after at least 1 week of initial treatment, OR
• Rash involving at least 25% of the body surface persisting after at least 2 weeks of initial treatment
• Concomitant use of steroids is permitted; steroid dose should not have been increased within a week prior to enrollment
• Patient, guardian or legally authorized representative is able and willing to provide informed consent
• Willing to use effective contraception; both women of childbearing potential and men who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days after the last dose of study drug

You may not qualify if:

• Prior second-line systemic treatment for GVHD
• Absolute neutrophil count (ANC) \< 2000/μL
• Administration of growth factor in order to maintain the ANC \> 2000/μL
• Platelet count \< 30,000/μL, (unsupported)
• Serum total bilirubin concentration \> upper limit of normal (ULN)
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3X ULN
• Calculated creatinine clearance \< 60 ml/min
• Peripheral neuropathy: clinical total neuropathy score (TNS) score \> 2
• Any Grade 3 or higher uncontrolled active infection within 1 week before enrollment
• Bullous formation or desquamation related to GVHD (stage 4 skin GVHD)
• Evidence of recurrent/persistent malignancy by cytogenetics, histology or flow cytometry
• GVHD after donor lymphocyte infusion (DLI)
• Clinical manifestations of chronic skin GVHD
• Women who are pregnant or lactating; women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test result within 7 days before the first dose of brentuximab vedotin; woman of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
• Patients with a known hypersensitivity to brentuximab vedotin

Sponsors & Collaborators

• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Merav Bar

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 7, 2012
• First Posted: June 12, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2016
• Last Updated: June 27, 2013

Record last verified: 2013-06

Locations

US (1)