Brentuximab Vedotin in Treating Patients With Steroid-Resistant Acute Graft-Versus-Host Disease
Withdrawn before enrolling · Phase 2
Conditions studied: Graft Versus Host Disease
In brief
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)
Key facts
- Study ID
- NCT01616680
- Run by
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
- People needed
- 0
- Starts
- 2012-09-01
- Last updated by the study team
- 2013-06-27
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
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
- History of Progressive multifocal leukoencephalopathy (PML)
Where it is running
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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