Engineered Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies (NCT02960646) | Clinical Trial Compass
CompletedPhase 1
Engineered Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
United States11 participantsStarted 2017-01-18
Plain-language summary
This pilot phase I trial studies the side effects of engineered donor stem cell transplant in treating patients with hematologic malignancies. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Using T cells specially selected from donor blood in the laboratory for transplant may stop this from happening.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Lack of a human leukocyte antigen (HLA) matched related donor, lack of an immediately available 8/8 HLA matched unrelated donor
* Patients must be diagnosed with a high-risk and/or advanced hematologic malignancy defined as one of the following
* Acute lymphocytic leukemia (ALL) in complete remission (CR)1 with high-risk features including adverse cytogenetic such as t(9;22), t(1;19), t(4;11), or MLL gene rearrangements; in second or greater morphologic remission; persistent minimal residual disease
* Acute myeloid leukemia (AML) in CR1 with intermediate-risk disease and persistent detectable minimal residual disease (MRD), or with high-risk features defined as: greater than 1 cycle of induction therapy required to achieve remission; preceding myelodysplastic syndrome (MDS) or myeloproliferative disease; presence of FLT3 mutations or internal tandem duplications, DNMT3a, TET2, MLL-partial tandem duplication (PTD), ASXL1, PHF6; FAB M6 or M7 classification; adverse cytogenetics including: -5, del 5q, -7, del7q, abnormalities involving 3q, 9q, 11q, 20q, 21q, 17, +8, complex (\> 3 abnormalities)
* Patients with AML must have less than 10% bone marrow blasts and \< 100/mcL absolute peripheral blood blast count
* Patients with AML in CR2, subsequent CR or with active disease at transplant (\< 10% bone marrow blasts)
* MDS with International Prognostic Scoring System (IPSS) intermediate-2 or higher, therapy-related MDS or chronic myelomonocytic leukemia (CMML)…
What they're measuring
1
Incidence of treatment failure defined as primary graft failure, grade 3-4 acute graft versus host disease (aGVHD), or non-relapse mortality