T-cell Depleted Donor Lymphocyte Infusion (DLI)for Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)
|ClinicalTrials.gov Identifier: NCT00242515|
Recruitment Status : Unknown
Verified January 2014 by National University Hospital, Singapore.
Recruitment status was: Recruiting
First Posted : October 20, 2005
Last Update Posted : January 8, 2014
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 (GVHD) based on standard classification of acute and chronic GVHD
- Improving hte disease remission rate in comparison with our previous study results.
- To investigate the impact of CD8+ depleted T-cell DLI in hematopoietic chimerism, and immunologic recovery of transplant patients.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Myelodysplastic Syndromes||Procedure: CD8+ T-cell depleted donor lymphocyte infusion||Phase 1 Phase 2|
The scientific investigation in this study protocol:
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||March 2005|
|Estimated Study Completion Date :||March 2008|
- Incidence rate of acute and chronic GVHD
- Disease remission rate post CD8+ depleted T-cell DLI
- Hematopoietic chimerism and immunologic recovery post CD8+ depleted T-cell DLI
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00242515
|Contact: Chien-Shing Chen, MDemail@example.com|
|Department of Hematology-Oncology, National University Hospital||Recruiting|
|Singapore, Singapore, 119074|
|Principal Investigator:||Chien-Shing Chen, MD||National University Hospital/National University Singapore|