Phase I Study of Prophylactic TCRαβ+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies
This study is being done to assess the safety and determine the maximum tolerable dose (MTD) of TCRαβ+/CD19+-depleted Donor Lymphocyte Infusion (αβT/B dep-DLI) after allogeneic stem cell transplant (allo-SCT) in highrisk patients with hematologic malignancies.
• Patients with high-risk myeloid or lymphoid malignancies determined to be eligible to undergo a related, allo-SCT using Disease Risk Index (DRI), including the conditions listed below. These criteria apply BEFORE cyto-reductive therapy given within 28 days of planned conditioning:
‣ Refractory acute myelogenous or lymphoid leukemia
⁃ Relapsed acute myelogenous or lymphoid leukemia
⁃ Myelodysplastic syndromes with 5 percent or more blasts
⁃ Chronic myelogenous leukemia in chronic phase 3 or more, blast phase presently, or second accelerated phase
⁃ Recurrent or refractory malignant lymphoma or Hodgkin's disease with less than a partial response at transplant
⁃ High risk chronic lymphocytic leukemia defined as no response or stable disease to the most recent treatment regimen
⁃ Other high risk hematologic malignancies for which allo-SCT is deemed clinically necessary per PI and based on institutional standards
• The donor for the allo-SCT will have been identified prior to participant recruitment and must be:
‣ Related AND
⁃ Matched OR mismatched OR haploidentical at Human Leukocyte Antigen (HLA) HLA-A, -B, -C, and -DRB1 by molecular methods
• Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
• Ability to understand and willingness to sign written informed consent document
• Willing to comply with all study procedures and be available for the duration of the study
• Individuals in sexual relationships that could result in pregnancy or impregnation of their partner must use an acceptable method of contraception§ from enrollment until 4 weeks after completing study treatment.