Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Pat… (NCT03399773) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes
United States31 participantsStarted 2022-05-10
Plain-language summary
This phase II trial studies how well donor umbilical cord blood transplant with ex-vivo expanded cord blood progenitor cells (dilanubicel) works in treating patients with blood cancer. Before the transplant, patients will receive chemotherapy (fludarabine, cyclophosphamide and in some cases thiotepa) and radiation therapy. Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.
Who can participate
Age range10 Years – 65 Years
SexALL
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Inclusion Criteria:
* Patients 10 to 65 years old with a hematologic malignancy in need of hematopoietic cell transplant who are \> 30 kg and without a suitable related donor
* Patient must have hematologic malignancy that meets institutional eligibility requirements for cord blood transplant
* Malignancies included are:
* Acute leukemia, including acute myeloid leukemia (AML), biphenotypic acute leukemia or mixed-lineage leukemia, acute lymphoblastic leukemia (ALL); all patients must be in complete response (CR) as defined by \< 5% blasts by morphology/flow cytometry in a representative bone marrow sample with adequate cellularity to assess remission status
* Myelodysplasia (MDS) International Prognostic Scoring System (IPSS) intermediate (Int)-2 or high risk (i.e., refractory anemia with excess blasts \[RAEB\], refractory anemia with excess blasts in transformation \[RAEBt\]) or refractory anemia with severe pancytopenia or high risk cytogenetics; blasts must be \< 10% in a representative bone marrow aspirate
* Chronic myeloid leukemia excluding refractory blast crisis; to be eligible in first chronic phase (CP1) patient must have failed or be intolerant to tyrosine kinase inhibitor therapy
* High dose TBI regimen: 10 to =\< 45 years
* Intermediate intensity regimen: 10 to =\< 65 years
* Patients 10 to =\< 45 years: Lansky (\< 16 years old) or Karnofsky (\>= 16 years old) \>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-1
* Patients \> 45 to =\< 65 years: Karno…