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

  • End date
    Jun 1, 2025
  • participants needed
  • sponsor
    Fred Hutchinson Cancer Center
Updated on 26 May 2022
chronic myeloid leukemia
graft versus host disease
myeloid leukemia
lymphoid leukemia
total body irradiation
hematologic malignancy
blast crisis
myelodysplastic syndromes
acute leukemia
white blood cell count
umbilical cord blood transplantation
flow cytometry
carbon monoxide
ejection fraction
bone marrow procedure
kinase inhibitor
serum bilirubin level
blast cells
blood cell count


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.



Patients receive either regimen A or regimen B.

REGIMEN A: Patients (18 through 45 years old) receive fludarabine intravenously (IV) over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Patients undergo total body irradiation (TBI) twice daily (BID) on days -4 to -1. Patients receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.

REGIMEN B: Patients (18 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Patients undergo TBI once daily (QD) on days -2 and -1. Patients receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.

After completion of study treatment, patients are followed up at 180 days, 1 year, and 2 years.

Condition Acute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Hematopoietic and Lymphoid Cell Neoplasm, Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts
Treatment cyclophosphamide, laboratory biomarker analysis, Fludarabine, Total-Body Irradiation, Umbilical Cord Blood Transplantation, thiotepa, Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion, Dilanubicel
Clinical Study IdentifierNCT03399773
SponsorFred Hutchinson Cancer Center
Last Modified on26 May 2022


Yes No Not Sure

Inclusion Criteria

Patient must have hematologic malignancy that meets institutional eligibility requirements for cord blood transplant
Malignancies included are
Myelodysplasia (MDS) International Prognostic Scoring System (IPSS) intermediate (Int)-2 or high risk (i.e., RAEB, RAEBt) or refractory anemia with severe pancytopenia or high risk cytogenetics; blasts must be < 10% in a representative bone marrow aspirate
High dose TBI regimen: 18 to =< 45 years
Intermediate intensity regimen: 18 to =< 65 years
Patients 18 to =< 45 years: Karnofsky (>= 18 years old) >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-1
Patients > 45 to =< 65 years: Karnofsky >= 70 or ECOG 0-1 and non-age adjusted comorbidity index =< 5
Calculated creatinine clearance must be > 60 mL and serum creatinine =< 2 mg/dL
Total serum bilirubin must be < 3 mg/dL unless the elevation is thought to be due to Gilbert's disease or hemolysis
Transaminases must be < 3 x the upper limit of normal per reference values of treating institution
Carbon monoxide diffusing capability (DLCO) corrected >= 60% normal (may not be on supplemental oxygen)
Left ventricular ejection fraction >= 50% OR
Shortening fraction > 26%
Ability to understand and the willingness to sign a written informed consent form
DONOR: Minimum requirement: The cord blood (CB) unit must be matched at a minimum at 4/6 HLA-A, B antigens and DRB1 allele with the recipient; therefore, 0-2 mismatches at the A or B or DRB1 loci based on intermediate resolution at HLA-A, B and high resolution allele level typing at HLA- DRB1 are allowed
DONOR: Institutional guidelines for HLA-match may be followed as long as the minimum criteria for HLA-matching as above are met
DONOR: The CB unit selected for transplant must have a MINIMUM of 2.5 x 10^7 TNC/kg
DONOR: The minimum recommended CD34/kg cell dose is 1.7 x 10^5 CD34/kg
DONOR: A domestic backup unit, meeting the same HLA and cell dose requirements, must be identified and reserved prior to the start of the treatment plan for possible infusion in the unlikely event of poor post-thaw viability of the primary CB unit

Exclusion Criteria

Uncontrolled viral or bacterial infection at the time of study enrollment
Active or recent (prior 6 month) invasive fungal infection unless cleared by infectious disease (ID) consult
History of human immunodeficiency virus (HIV) infection
Pregnant or breastfeeding
Prior allogeneic transplant
Central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy; diagnostic lumbar puncture is to be performed
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