CD8 Depleted, Non-engrafting, HLA Mismatched Unrelated Infusion With MDS and Secondary AML (NCT04620681) | Clinical Trial Compass
CompletedPhase 1/2
CD8 Depleted, Non-engrafting, HLA Mismatched Unrelated Infusion With MDS and Secondary AML
United States19 participantsStarted 2021-01-14
Plain-language summary
The purpose of the study is to determine the safety of an investigational treatment for myelodysplastic syndrome (MDS) after the first therapy (such as azacitidine or decitabine) stops working or after progression of MDS to acute myeloid leukemia (AML). Funding source - FDA OOPD.
Who can participate
Age range18 Years – 79 Years
SexALL
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Inclusion Criteria:
Myelodysplastic Syndrome (MDS) having failed hypomethylating agent (HMA) therapy cohort:
* Age 18-79 years, inclusive
* Pathologically confirmed MDS or myelodysplastic/myeloproliferative overlap (MDS/MPN)
* IPSS-R score intermediate, high or very high
* Must have failed therapy with an HMA (defined as lack of response by International Working Group criteria (1) or intolerance of the drug)
Secondary Acute Myeloid Leukemia (sAML):
* Pathologically confirmed AML according to World Health Organization (WHO) criteria
* Evidence of an antecedent hematologic disorder (AHD) prior to acute leukemia including a known prior diagnosis of MDS, MPN or MDS/MPN or data suggestive of an AHD such as cytopenias, fibrosis, macrocytic anemia, cellular or dysplasia at or prior to the time of diagnosis. If available, MDS-defining karyotypes (-7/del(7q), -5/del(5q), del(13q), del(11q), del(12p), t(12p), del(9q), idic(X)(q13), t(17p) (unbalanced translocations) or i(17q) (ie, loss of 17p), t(11;16)(q23;p13.3), t(3;21)(q26.2;q22.1), t(1;3)(p36.3;q21), t(2;11)(p21;q23), inv(3)(q21q26.2), t(6;9)(p23;q34)) or somatic mutations in multiple genes including p53, TET2, JAK2, CALR, MPL, ASXL1, RUNX1, SRSF2, SF3B1, U2AF1, ZRSR2, ASXL1, EZH2, BCOR, or STAG2 would also confirm eligibility.
* Age 60-79 years, inclusive
* May be previously untreated
For both cohorts:
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Deemed eligible to receive cytotoxic chemotherapy
*…
What they're measuring
1
Maximum Tolerated Dose of CD8 Depleted Non-engrafting HLA-mismatched Unrelated Donor Lymphocytes Infusion (NE-DLI)
Timeframe: Up to 60 days per dose level
Trial details
NCT IDNCT04620681
SponsorH. Lee Moffitt Cancer Center and Research Institute