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
NCT ID: NCT03399773
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
31 participants
INTERVENTIONAL
2022-05-10
2027-04-02
Brief Summary
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Detailed Description
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Patients receive either regimen A or regimen B.
REGIMEN A: Patients (10 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 (10 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.
All patients undergo bone marrow aspirate and biopsy as clinically indicated during screening and on study. Patients undergo multigated acquisition scan (MUGA) or echocardiography (ECHO), and computed tomography (CT) during screening. Patients also undergo blood sample collection on study.
After completion of study treatment, patients are followed up at 180 days, 1 year, and 2 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (chemotherapy, TBI, NLA101)
Patients receive either regimen A or regimen B.
REGIMEN A: Patients (10 through 45 years old) receive fludarabine IV over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Patients undergo TBI 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 (10 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 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.
All patients undergo bone marrow aspirate and biopsy as clinically indicated during screening and on study. Patients undergo MUGA or ECHO, and CT during screening. Patients also undergo blood sample collection on study.
Dilanubicel
Given IV
Cyclophosphamide
Given IV
Fludarabine
Given IV
Thiotepa
Given IV
Total-Body Irradiation
Undergo TBI
Umbilical Cord Blood Transplantation
Given IV
Laboratory Biomarker Analysis
Correlative studies
Biospecimen Collection
Undergo blood sample collection
Bone Marrow Aspirate
Undergo bone marrow aspirate and biopsy
Bone Marrow Biopsy
Undergo bone marrow aspirate and biopsy
Multigated Acquisition Scan
Undergo MUGA
Electrocardiography
Undergo ECHO
Computed Tomography
Undergo CT
Interventions
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Dilanubicel
Given IV
Cyclophosphamide
Given IV
Fludarabine
Given IV
Thiotepa
Given IV
Total-Body Irradiation
Undergo TBI
Umbilical Cord Blood Transplantation
Given IV
Laboratory Biomarker Analysis
Correlative studies
Biospecimen Collection
Undergo blood sample collection
Bone Marrow Aspirate
Undergo bone marrow aspirate and biopsy
Bone Marrow Biopsy
Undergo bone marrow aspirate and biopsy
Multigated Acquisition Scan
Undergo MUGA
Electrocardiography
Undergo ECHO
Computed Tomography
Undergo CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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: Karnofsky \>= 70 or ECOG 0-1 and non-age adjusted comorbidity index =\< 5
* Adults: Calculated creatinine clearance must be \> 60 mL and serum creatinine =\< 2 mg/dL
* Children (\< 18 years old): Calculated creatinine clearance must be \> 60 mL/min
* 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)
* For pediatric patients unable to perform pulmonary function tests, O2 saturation \> 92% on room air
* Left ventricular ejection fraction \>= 50% OR
* Shortening fraction \> 26%
* Ability of participant or legally authorized representative 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 backup unit 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. A suitable back up unit will be considered, as follows:
* Must be matched at a minimum at 4/6 HLA-A, B, DRBl loci with the recipient. Therefore 0-2 mismatches at the A or B or DRBl loci based on intermediate resolution A, B antigen and DRBl allele typing for determination of HLA-match is allowed (Fred Hutch Protocol 2010).
* Must contain a MINIMUM of 1.5 x 10\^7 TNC/kg to ensure the same requirement we use for a standard double CBT per CB selection guideline (Fred Hutch Protocol 2010).
Exclusion Criteria
* 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
* \< 30 kg
10 Years
65 Years
ALL
No
Sponsors
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Nohla Therapeutics, Inc.
INDUSTRY
National Cancer Institute (NCI)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Filippo Milano
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2017-02205
Identifier Type: REGISTRY
Identifier Source: secondary_id
9910
Identifier Type: OTHER
Identifier Source: secondary_id
RG9218003
Identifier Type: OTHER
Identifier Source: secondary_id
9910
Identifier Type: -
Identifier Source: org_study_id
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