Status:
COMPLETED
Thymoglobuline in Non-myeloablative Allogeneic Stem-cell Transplantation
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Stem Cell Transplantation
Graft Vs Host Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Allogeneic stem cell transplantation is the treatment of choice for a growing number of malignant and non-malignant indications. Until recently, myeloablative in conjunction with immunosuppressive con...
Detailed Description
Allogeneic stem cell transplantation (SCT) from a fully matched donor is the treatment of choice for a growing number of malignant and non-malignant indications. Until recently, myeloablative in conju...
Eligibility Criteria
Inclusion
- Patients ages 18-75 years old with a disease necessitating allogeneic SCT.
- Patients must have an HLA compatible donor willing and capable of donating peripheral blood stem cells preferably, or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (HLA compatible defined as 5/6 or 6/6 matched related \[A, B, DR\] or 8/8 molecular \[A, B, C, DR\] matched unrelated donor).
- Both patients and donor must sign written informed consents.
- Patients must have an ECOG performance status (PS) ≤ 2; Creatinine \< 2.0 mg/dl; Ejection fraction \> 40%; Diffusing capacity of the lung for carbon monoxide (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 thymoglobuline or other rabbit produced immunoglobulin.
- 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 :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00130754
Start Date
February 1 2005
End Date
November 1 2007
Last Update
February 23 2011
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel, 91120