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Bone Marrow Transplant

Brentuximab Vedotin for Steroid-Resistant Acute GVHD (FH 2589)
Phase II Study to Evaluate the Efficacy of Brentuximab Vedotin in Patients with Steroid-Resistant Acute GVHD
Status Conditions Phase Study ID
Recruiting Chronic Graft Versus Host Disease (cGVHD) Phase II FH 2589
NCT01616680
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)


Investigator
Merav Bar, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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
Exclusions (conditions that would prevent participation in this study)
  • 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
  • History of Progressive multifocal leukoencephalopathy (PML)
Last Updated
November 30, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.