Status:
UNKNOWN
Multi Donor Mismatched Stem Cell Transplantation (MDT)
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Graft-Versus-Host Disease
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE1
PHASE2
Brief Summary
The proposed research focuses on the development of innovative protocol of mismatched stem cell transplantation with combined 2 different haplo stem cell transplantation (SCT) donors which are mismatc...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patient age 0-70 years old with leukemia in 1st remission at high risk of relapse because of unfavorable prognostic features, at 2nd CR or MDS without an readily available matched donor (related or unrelated).
- 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 criteria:
- Not fulfilling any of the inclusion criteria.
- Not in CR (if the indication for transplant is leukemia).
- Active life-threatening infection.
- Overt untreated infection.
- 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, HCV, evidence of bone marrow disease, unable to donate bone marrow or peripheral blood due to concurrent medical condition).
- Previous autologous or allogeneic stem cell transplantation.
- Inability to comply with study requirements.
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00716690
Start Date
July 1 2008
End Date
June 1 2020
Last Update
February 19 2016
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel