Status:
UNKNOWN
T-cell Depleted Donor Lymphocyte Infusion (DLI)for Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)
Lead Sponsor:
National University Hospital, Singapore
Collaborating Sponsors:
Singapore General Hospital
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
21-90 years
Phase:
PHASE1
PHASE2
Brief Summary
Primary Objectives: This a pilot project to determine the feasibility of the preemptive CD8+ depleted T-cell donor lymphocyte infusion (DLI) in: * Reducing the incidence of graft versus host disease...
Detailed Description
The scientific investigation in this study protocol: 1. Define the role of preemptive and specific DLI in preserving the GVL effect in the setting of NMT. The ability of selecting components of T cel...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of AML or high risk MDS in the following disease stages: Induction failure, first or subsequent remission, or untreated first relapse.
- Patient 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 or 6/6 molecular matched unrelated donor)
- Both patient and donor must sign written informed consent forms.
- Patients must have:
- ECOG PS \</= 2;
- Ejective fraction \> 40%;
- DLCO \> 40% of predicted;
- Serum bilirubin \</= 1.5x institutional upper limit of normal;
- SGPT (ALT) and SGOT (AST) \</= 2.5x institutional upper limit of normal;
- Serum creatinine \</= 2x upper limit of normal;
- Creatinine clearance \>/= 60mL/min. However, renal dysfunction is not an absolute contraindication for NMT as dialysis can be performed during NMT.
Exclusion
- Not fulfilling any of the inclusion criteria
- Active life-threatening infection
- Overt untreated infection
- HIV positivity, hepatitis B or C antigen positivity with active hepatitis
- Pregnant or lactating women
- Donor contraindication (HIV seropositive confirmed by Western blot; hepatitis B antigenemia)
- Unable to donate bone marrow or peripheral blood due to concurrent medical condition
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00242515
Start Date
March 1 2005
End Date
March 1 2008
Last Update
January 8 2014
Active Locations (1)
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1
Department of Hematology-Oncology, National University Hospital
Singapore, Singapore, 119074