Preemptive CD8+ T-Cell Depleted Donor Lymphocyte Infusion (DLI) Following Nonmyeloablative Stem Cell Transplantation (NMT) for Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)
21 Years
90 Years
Both
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Trial Information
Preemptive CD8+ T-Cell Depleted Donor Lymphocyte Infusion (DLI) Following Nonmyeloablative Stem Cell Transplantation (NMT) for Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)
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 cells for transplant and DLI
will allow us to test the hypothesis of distinctive roles in subsets of T cells. It
was found that CD8-depleted DLI was administered to prevent relapse after TCD (T-cell
depleted) BMT (bone marrow as the stem cell source) or CD34-selected PBSC.
Whether preemptive CD8-depleted DLI can perform this function after nonmyeloablative
transplantation (NMT) needs to be established, as proposed in our study. If there
turns out to be a role for DLI in these circumstances, a CD8-depleted lymphocyte
product that can limit GVHD would be a very attractive option. We would also define
the relationship of the level of donor chimerism and disease control.
2. Investigate the impact of CD8-depleted DLI in NMT at specific doses and time points for
the reduction of GVHD. The GVHD pattern may vary between different ethnic populations
as suggested by our earlier NMT study. Our current proposed study will further shed
light on the optimal GVHD prophylaxis regimen in the Singapore patient population.
Inclusion Criteria:
1. Confirmed diagnosis of AML or high risk MDS in the following disease stages:
Induction failure, first or subsequent remission, or untreated first relapse.
2. 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)
3. Both patient and donor must sign written informed consent forms.
4. Patients must have:
- ECOG PS
- Ejective fraction > 40%;
- DLCO > 40% of predicted;
- Serum bilirubin
- SGPT (ALT) and SGOT (AST)
- Serum creatinine
- Creatinine clearance >/= 60mL/min. However, renal dysfunction is not an
absolute contraindication for NMT as dialysis can be performed during NMT.
Exclusion Criteria:
1. Not fulfilling any of the inclusion criteria
2. Active life-threatening infection
3. Overt untreated infection
4. HIV positivity, hepatitis B or C antigen positivity with active hepatitis
5. Pregnant or lactating women
6. Donor contraindication (HIV seropositive confirmed by Western blot; hepatitis B
antigenemia)
7. Unable to donate bone marrow or peripheral blood due to concurrent medical condition
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence rate of acute and chronic GVHD
Principal Investigator
Chien-Shing Chen, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
National University Hospital/National University Singapore
Authority:
Singapore: Health Sciences Authority
Study ID:
TP02/28/04
NCT ID:
NCT00242515
Start Date:
March 2005
Completion Date:
March 2008
Related Keywords:
- Acute Myeloid Leukemia
- Myelodysplastic Syndromes
- High risk Myelodysplastic Syndrome (MDS)
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Myelodysplastic Syndromes
- Preleukemia
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