Cancer, Graft-Versus-Host Disease
Conditions
Brief summary
A clinical trial to assess safety and two regimens of (MEDI-507) a drug given to stem cell and bone marrow recipients who have a mid-grade acute Graft-versus-Host Disease.
Detailed description
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).
Interventions
DRUGMEDI-507
0.12 mg/kg of MEDI-507 given every third day for 4 doses followed by doses of normal saline on Days 16, 23, 30, and 37.
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety was assessed by the direct observation of patients, medical history, and clinical laboratory evaluation to determine the incidence of patients experiencing AEs. | Day 0-60 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics, Lymphocyte Phenotype and CD2 Receptor Occupancy Pharmacodynamics | Study Days 12 and 44 |
Countries
United States
Outcome results
None listed