Status:
TERMINATED
A Study to Evaluate the Effect of ATG-F on Engraftment, Graft Versus Host Disease (GVHD) and Graft Versus Leukemia (GVL) Effect in Haplo-identical SCT
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Allogeneic Haplo-Stem Cell Transplatation (SCT)
Graft Versus Host Disease
Eligibility:
All Genders
3-70 years
Phase:
PHASE3
Brief Summary
This study is planned to evaluated whether ATG is needed in haploidentical stem cell transplantation
Eligibility Criteria
Inclusion
- Patient age 3-70 years old with a disease necessitating allogeneic SCT.
- Patients must have a mismatched donor willing and capable of donating peripheral blood stem cells and/or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (mismatched defined as 3/6-4/6 HLA matching).
- Each patient / patient's guardian must sign written informed consent.
- 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.
- Known hypersensitivity to ATG.
- HIV seropositivity, Hepatitis B or C antigen positivity with evidence of active hepatitis.
- Pregnant or lactating women.
- Donor contraindication (HIV seropositive confirmed by Western Blot Hepatitis B antigenemia; positive HCV antibodies with positive HCV PCR; 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 :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00616954
Start Date
May 1 2008
End Date
September 1 2010
Last Update
April 21 2015
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel, 91120