Prophylactic TCRaB+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Trans… (NCT07285668) | Clinical Trial Compass
SuspendedNot Applicable
Prophylactic TCRaB+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies
Stopped: Protocol Modifications
United States38 participantsStarted 2026-02-26
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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…
What they're measuring
1
Incidence of Adverse Events (AEs) from DLI to day 28 post-DLI
Timeframe: up to day 28 post-DLI (approximately day 63 on study)
2
Maximum Tolerated Dose or Maximum Administered Dose
Timeframe: up to day 28 post-DLI (approximately day 63 on study)