Clinical trial · Interventional
CD8+ T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation
CD8+ T Cell Depletion as Graft Versus Host Disease Prophylaxis After HLA-Matched Unrelated Donor Non-myeloablative Peripheral Blood Stem Cell Transplantation
NCT00333190CI-TRIAL-00006527completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this trial is to determine if selectively removing only a small subset of T cells, called CD8+ T cells, is safe and if it can reduce the risk of graft versus host disease (GVHD) without losing the anti-cancer effects.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALL | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| CML | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Hodgkin's Lymphoma | Hodgkin Lymphoma | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| NHL | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD+8 T cell depletion | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the initial engraftment of HLA matched unrelated donor mobilized peripheral blood stem cells depleted of CD+8 cells.
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- To assess sustained engraftment
- timeFrame
- 2 years
- measure
- to determine the incidence of GVHD
- timeFrame
- 2 years
- measure
- to assess disease relapse.
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Hematologic malignancies that are candidates for allogeneic non-myeloablative stem cell transplantation * AML or ALL in first or subsequent remission, or in resistant or untreated relapse with marrow blast \< 20% of cellularity * CML in first or subsequent chronic phase, or accelerated phase * Myelodysplastic syndrome with \< 20% marrow blasts * NHL or Hodgkin's lymphoma in second or greater remission, or partial remission after salvage therapy, and in patients with marrow involvement, \<20% involvement in BM * CLL RAI stage 2-4, which has progressed after initial fludarabine containing therapy, and BM involvement of \< 20% * Multiple myeloma stage II-III, in first or subsequent plateau phase with \<20% BM plasma cells * Available unrelated donor who is fully HLA matched at HLA-A,B,C and DRB1 * Age 18 or greater * Performance status 0-2 * Life expectancy of \> 100 days * No HLA-matched related donor available Exclusion Criteria: * Myeloproliferative disorders other than CML * MDS with myeloproliferative features, or CMML * High grade Burkitts or Burkitts-like Non-Hodgkin's lymphoma * Prior allogeneic stem cell transplant * Active CNS involvement with disease * Uncontrolled infection * Pregnancy * Evidence of HIV infection * Heart failure uncontrolled my medications * Total bilirubin \> 2.0 mg/dl that is due to hepatocellular dysfunction * AST \> 2 x institutional upper limit of normal * Serum creatinine \> 2.0 mg/dl
References
Publications (0)
Data not yet available
No reference posted for this study.