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 allo-SCT including but not limited to the conditions listed below. These criteria apply at the disease diagnosis or any time prior to the cyto-reductive therapy given before the planned conditioning:
‣ Refractory acute myelogenous (AML) or lymphoid leukemia (ALL)
⁃ Relapsed AML or ALL
⁃ AML in European LeukemiaNet (ELN) high risk per cytogenetic and mutation
⁃ Any patients with minimal residual disease (MRD+) disease by flow cytometry or with active disease (not in complete remission (CR)) prior to allo-SCT
⁃ Myelodysplastic syndromes (MDS) with 5% or more blasts at initial diagnosis, or anytime during their treatment prior to allo-SCT.
⁃ Myelodysplastic syndrome (MDS) high risk or very high risk per Revised International Prognostic Scoring System (IPSS-R) or Molecular International Prognostic Scoring System (IPSS-M)
⁃ Chronic myelogenous leukemia (CML) in chronic phase failed 3 or more treatments, in accelerated or blast phase
⁃ High risk primary myelofibrosis (PMF) per Dynamic International Prognostic Scoring System (DIPSS)-plus or Mutation-enhanced International Prognostic Scoring System for Transplant-age Patients (MIPSS70+)
⁃ PMF in accelerated or blast 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 must be:
‣ Related AND
⁃ Matched OR mismatched OR haploidentical at HLA-A, -B, -C, and -DRB1 by molecular methods
• 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.