Status:
TERMINATED
Alefacept for Prevention of Graft Versus Host Disease (GVHD)
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
14-75 years
Phase:
PHASE3
Brief Summary
Alefacept (AMEVIVE®) is an immunosuppressive dimeric fusion protein. It was shown to interfere with lymphocyte activation by specifically binding to the lymphocyte antigen, CD2, and inhibiting LFA-3/C...
Eligibility Criteria
Inclusion
- Patient age 14-75 years old with a disease necessitating allogeneic SCT.
- In order to increase security, only full matched donors will be allowed and must be willing and capable of donating peripheral blood stem cells preferably, or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated.
- Patients must sign written informed consents.
- Patients must have an ECOG PS ≤ 2; creatinine \< 2.0 mg/dl; ejection fraction \> 40%; DLCO \> 50% of predicted; serum bilirubin \< 3 gm/dl; elevated GPT or GOT \> 3 x normal values.
Exclusion
- Not fulfilling any of the inclusion criteria.
- Active life-threatening infection.
- Overt untreated infection.
- Hypersensitivity to alefacept.
- HIV seropositivity, Hepatitis B or C antigen positivity with active hepatitis.
- Pregnant or lactating women.
- Donor contraindication (HIV seropositive confirmed by western blot).
- Hepatitis B antigenemia.
- Evidence of bone marrow disease.
- Unable to donate bone marrow or peripheral blood due to concurrent medical condition.
- Inability to comply with study requirements.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00361413
Start Date
June 1 2006
End Date
December 1 2013
Last Update
April 21 2015
Active Locations (1)
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1
Department of Stem Cell Transplantation & Cancer Immunotherapy
Jerusalem, Israel, 91120