Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MedImmune LLC
To assess the safety of two regimens of MEDI-507 administered to stem cell and bone marrow allograft recipients who have at least grade II acute GVHD and who have not achieved a satisfactory response to at least three days of corticosteroid therapy (2 mg/kg/day of methylprednisolone or its equivalent).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Allogeneic bone marrow or hematopoietic stem cell graft recipients
Acute GVHD of at least grade II severity
Failure of GVHD to improve on at least 2 mg/kg/day of methylprednisolone or prednisone for at least three days or recurrence of acute GVHD as corticosteroids are tapered from initial treatment of the initial episode of GVHD
Evidence of engraftment (ANC over 1000 cells/mm3)
Histologic evidence of GVHD from biopsy performed during the current episode
Received GVHD prophylaxis of methotrexate, tacrolimus or cyclosporine
Age at least 18 years
Body weight under 130 kg
Both males and females are eligible but females of childbearing potential will use an accepted method of avoiding pregnancy for at least 60 days after the end of treatment (which includes oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or a sterile sexual partner)
You may not be if
Previous receipt of MEDI-507
Clinical or histologic manifestation of chronic GVHD
Previous treatment with any anti-T-cell antibodies such as OKT®3 or daclizumab (Zenapax®)
Receipt of antithymocyte globulin (ATGAM® or other ATG) since the day of transplant
More than one allogeneic bone marrow or hematopoietic stem cell allograft
Moribund and unlikely (in the opinion of the investigator) to survive 15 days
Use of other investigational agents within 30 days (this does not include the use of licensed agents for indications not listed in the package insert)
Any of the following clinical settings or diagnoses:
Ø documented or presumed significant active infection Ø pregnancy or nursing mother Ø evidence of infection with HIV-1, hepatitis B or C virus Ø hemodialysis or chronic peritoneal dialysis Ø use of a ventilator
Histologically confirmed veno-occlusive disease of the liver
Ascites on physical examination (this does not include small amounts of ascitic fluid detected only on ultrasound)
