CC-4047 (Pomalidomide) for Graft vs. Host Disease

Completed · Phase 2

Conditions studied: Graft vs Host Disease

In brief

This study will test the safety and effectiveness CC-4047 (pomalidomide) in patients with advanced, steroid refractory graft-versus-host disease.

Key facts

Study ID

NCT00770757

Run by

Washington University School of Medicine

People needed

13

Starts

2009-02-01

Expected to finish

2011-10-01

Last updated by the study team

2016-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Pregnant or lactating females.
• New immunosuppressive therapy started within the preceding 4 weeks.
• Extracorporeal photopheresis within the preceding 3 months.
• Hypersensitivity to any immune modulator drug (IMiD™).
• Unable to take prophylactic anticoagulation.
• Any condition which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Acute, persistent, recurrent or late-onset acute GvHD defined by NIH criteria.
• Any of the following laboratory values at registration:
• absolute neutrophil count (ANC) less than 1.0 x 109/L,
• platelets less than 75 x 109/L, or
• creatinine clearance less than 50 mL/min (Cockroft-Gault formula).
• Uncontrolled infection requiring systemic antibiotics.
• Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection.
• Known uncontrolled arrhythmias or symptomatic heart disease or left ventricular ejection fraction less than 40% (an ECHO should be performed as clinically indicated)
• Recurrence of cancer for which the transplant was done except for presence of minimal residual disease by PCR.
• Other cancer less than or equal to 2 years prior study-entry except:
• Basal cell carcinoma of the skin,
• Squamous cell carcinoma of the skin,
• Carcinoma in situ of the cervix,
• Carcinoma in situ of the breast, or
• Prostate cancer (Tumor, Node, Metastasis [TNM] stage T1a or T1b)

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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