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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

StatusActive, Not Recruiting
PhasePhase 2
Started2022-05-10
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 0 → 1 primary endpoints
See other at-risk trials from Fred Hutchinson Cancer Center

Amendment history

2026-07-09
Study Status, Outcome Measures, Outcome Measures (Results) v34
Primary endpoint(s) modified
Results first postednot stated→2026-07-10
Secondary endpointsdetails revised at 1 of 8 entries
2026-06-01
Study Status, Outcome Measures, Baseline Characteristics, Outcome Measures (Results), Adverse Events v33
Secondary endpoints8 entries, revised
Incidence and SeverityNumber of Participants With Acute Graft Versus Host Disease (GVHDaGVHD), by Grade Incidence and SeverityNumber of Participants With Chronic Graft Versus Host Disease (GVHDcGVHD) Incidence, andby Severity Number of Participants With Chronic Graft Versus Host Disease (GVHDcGVHD), by Severity IncidenceNumber of Participants Who Experienced Non-relapse Mortality IncidenceNumber of Participants Who Experienced Non-relapse Mortality
Primary endpoints1 entry, revised
IncidenceNumber of Participants With Graft Failure
2026-04-21
Study Status, Sponsor/Collaborators, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v32
Secondary endpoints8 entries, revised
TimeNumber of Participants Who Experienced Grade ≥3 Adverse Events Related to neutrophilStudy engraftmentProduct Time to plateletNeutrophil engraftmentEngraftment IncidenceTime ofto adversePlatelet events Incidence of non-relapse mortality Incidence of non-relapse mortalityEngraftment Incidence and severitySeverity of acuteAcute graftGraft versusVersus hostHost diseaseDisease (GVHD) Incidence and severitySeverity of chronicChronic graftGraft versusVersus hostHost diseaseDisease (GVHD) Incidence and severitySeverity of chronicChronic graftGraft versusVersus hostHost diseaseDisease (GVHD) Incide [...]
Primary endpoints1 entry, revised
Incidence of graftGraft failureFailure
2025-08-25
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v31
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2025-11-15→confirmed 2025-06-09
Completion date2027-09-30→2027-04-02
Enrollment targetestimated 35→confirmed 31
Study sitesdetails revised at 1 of 1 site
2025-04-09
Study Status v30
Primary completion date2025-03-31→2025-11-15
Completion date2027-03-31→2027-09-30
Show 29 earlier versions
2024-11-15
Study Status, Study Design, Eligibility v29
Primary completion date2024-12-12→2025-03-31
Completion date2026-10-31→2027-03-31
Enrollment target20→35
Eligibility criteria+97 characters
[...] ring 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 [...]
2024-10-14
Study Status v28
Primary completion date2024-10-08→2024-12-12
Completion date2026-06-30→2026-10-31
2024-08-16
2 amendments v26-v27
2 re-verifications since 2024-02-13, no change to tracked fields
2024-01-24
Suspended→Recruiting Study Status, Study Design, Contacts/Locations v25
Trial statusSuspended→Recruiting
Reason stoppedStudy has met its initial enrollment goal and researchers are modifying study to expand enrollment. Patient treatment and other protocol…→not stated
Enrollment target15→20
Study sitesdetails revised at 1 of 1 site
2024-01-08
Recruiting→Suspended Study Status, Contacts/Locations v24
Trial statusRecruiting→Suspended
Reason stoppednot stated→Study has met its initial enrollment goal and researchers are modifying study to expand enrollment. Patient treatment and other protocol…
Study sitesdetails revised at 1 of 1 site
2023-11-02
Study Status v23
Primary completion date2023-10-31→2024-10-08
Completion date2025-10-31→2026-06-30
2023-09-15
Study Status, Study Description, Arms and Interventions, Eligibility v22
InterventionsCyclophosphamide (Drug), Dilanubicel (Biological), Fludarabine (Drug), Laboratory Biomarker Analysis (Other), Thiotepa (Drug), Total-Body…→Biospecimen Collection (Procedure), Bone Marrow Aspirate (Procedure), Bone Marrow Biopsy (Procedure), Computed Tomography (Procedure)…
Eligibility criteria+392 characters
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 institut [...] to tyrosine kinase inhibitor therapy High dose TBI regimen: 1810 to =< 45 years Intermediate intensity regimen: 1810 to =< 65 years Patients 1810 to =< 45 years:Lansky (< 16 years old) or Karnofsky (>= 1816 years old) >= 70 or Eastern Cooperative Oncology Group (ECO [...] 70 or ECOG 0-1 and non-age adjusted comorbidity index =< 5 Adults: Calculated creatinine clearance mu [...] [...]
Study description+291 characters
OUTLINE: Patients receive either regimen A or regimen B. REGIMEN A: Patients (1810 through 45 years old) receive fludarabine intravenously (IV [...] IV within the next 24 hours on day 0. REGIMEN B: Patients (1810 through 65 years old) receive fludarabine IV over 30-60 min [...] llowed 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 coll [...] [...]
2023-06-02
Study Status v21
Primary completion date2023-06-01→2023-10-31
Completion date2025-06-01→2025-10-31
2023-03-13
Study Status, Outcome Measures, Eligibility v20
Eligibility criteria+460 characters
[...] ecommended 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 [...] ely event of poor post-thaw viability of the primary CB unit. A suitable back up unit will be considered, as follows: i. Must be matched at a minimum at 4/6 HLA-A, B, DRB1 loci with the recipient. Therefore 0-2 mismatches at the A or B or DRB1 loci based on intermediate resolution A, B antigen and DRB1 allele typing for determination of HLA-match is allowed (F [...] Exclusion Criteria: Uncontrolled viral or bacteri [...]
Secondary endpoints5 to 8 entries
Incidence and severity of acute graft versus host disease (GVHD) Incidence and severity of chronic graft versus host disease (GVHD) Incidence and severity of chronic graft versus host disease (GVHD)
Primary endpoints3 to 1 entries
Incidence and severity of acute graft versus host disease (GVHD) Incidence and severity of chronic graft versus host disease (GVHD)
2022-11-22
Study Status v19
Re-verified, no change to tracked fields
2022-05-11
Study Identification, Study Status, Study Description, Arms and Interventions, Eligibility v18
Start dateestimated 2022-06-02→confirmed 2022-05-10
InterventionsCyclophosphamide (Drug), Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion (Biological), Fludarabine (Drug), Laboratory Biomarker…→Cyclophosphamide (Drug), Dilanubicel (Biological), Fludarabine (Drug), Laboratory Biomarker Analysis (Other), Thiotepa (Drug), Total-Body…
Eligibility criteria-5 characters
[...] splant Malignancies included are: Acute leukemia, including Acuteacute myeloid leukemia (AML), biphenotypic acute leukemia or mixe [...] t be < 10% in a representative bone marrow aspirate Chronic Myeloidmyeloid Leukemialeukemia excluding refractory blast crisis; to be eligible in first [...] gimen: 18 to =< 45 years Intermediate intensity regimen: 18 to =< 65 years Patients 18 to =< 45 years: Karnofsky (>= 18 yea [...] (prior 6 month) invasive fungal infection unless cleared by innovationinfectious and developmentdisease (ID) consult History of human immunodeficiency virus (HIV) [...]
Study description+66 characters
[...] tients receive unmanipulated cord blood unit IV followed by NLA101dilanubicel IV within the next 24 hours on day 0. REGIMEN B: Patients ( [...] n 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 NLA101dilanubicel IV within the next 24 hours on day 0. After completion of s [...]
2022-05-02
Study Status v17
Start date2022-04-30→2022-06-02
2022-03-31
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v16
Trial statusNot Yet Recruiting→Recruiting
Start date2022-03→2022-04-30
Study sitesdetails revised at 1 of 1 site
2022-03-02
Study Status v15
Start date2022-02→2022-03
2022-02-02
Study Identification, Study Status, Arms and Interventions v14
InterventionsCyclophosphamide (Drug), Fludarabine (Drug), Laboratory Biomarker Analysis (Other), Omidubicel (Biological), Thiotepa (Drug), Total-Body…→Cyclophosphamide (Drug), Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion (Biological), Fludarabine (Drug), Laboratory Biomarker…
2021-11-12
Study Status v13
Start date2021-11-04→2022-02
2021-10-04
Study Status v12
Start date2021-10-02→2021-11-04
2021-09-02
Study Status v11
Start date2021-09-02→2021-10-02
2021-08-02
Study Status v10
Start date2021-08-02→2021-09-02
2021-07-02
Study Status v9
Start date2021-07-01→2021-08-02
2021-06-01
Study Status v8
Start date2021-06-01→2021-07-01
2021-03-29
Study Identification, Study Status v7
Re-verified, no change to tracked fields
2021-03-25
Withdrawn→Not Yet Recruiting Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v6
Trial statusWithdrawn→Not Yet Recruiting
Reason stoppedDevelopment halted in HSCT.→not stated
Primary completion date2020-01→2023-06-01
Completion date2021-08→2025-06-01
Start date2018-08-15→2021-06-01
Enrollment target0→15
Study sites2→1
Lead sponsorNohla Therapeutics, Inc.→Fred Hutchinson Cancer Center
InterventionsCyclophosphamide (Drug), Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion (Biological), Fludarabine (Drug), Thiotepa (Drug), Total-Body…→Cyclophosphamide (Drug), Fludarabine (Drug), Laboratory Biomarker Analysis (Other), Omidubicel (Biological), Thiotepa (Drug), Total-Body…
Eligibility criteria+1,973 characters
Key Criteria: Inclusion Criteria: Patient must have hematologic malignancy [...] splant Malignancies included are: Acute leukemia, including acuteAcute 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., RAEB, RAEBt) or refractory anemia wit [...] [...]
Secondary endpoints6 to 5 entries
Incidence of CTCAEadverse Grade >=3 Adverse Events within the first 24 hours after infusionevents Incidence of severenon-relapse acute graft-versus-host disease (GVHD) Incidence of chronic graft-versus-host disease (GVHD)mortality
Primary endpoints1 to 3 entries
Incidence and severity of acute graft versus host disease (GVHD) Incidence and severity of chronic graft versus host disease (GVHD)
Study description+829 characters
OUTLINE: 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. [...]
Collaborators3 entries, revised
FredNohla HutchinsonTherapeutics, Cancer CenterInc.
Study title+46 characters
Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With HematologicAcute MalignanciesLeukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes
2019-03-11
Suspended→Withdrawn Study Status, Study Design v5
Trial statusSuspended→Withdrawn
Reason stoppedDevelopment suspended in HSCT.→Development halted in HSCT.
Enrollment targetestimated 15→confirmed 0
2019-02-22
Recruiting→Suspended Study Status, Contacts/Locations v4
Trial statusRecruiting→Suspended
Reason stoppednot stated→Development suspended in HSCT.
Start dateestimated 2018-10→confirmed 2018-08-15
Study sitesdetails revised at 2 of 2 sites
2018-10-01
Not Yet Recruiting→Recruiting Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2022-03-15→2020-01
Completion date2022-03-15→2021-08
Start date2018-05-15→2018-10
Lead sponsorFred Hutchinson Cancer Center→Nohla Therapeutics, Inc.
InterventionsCyclophosphamide (Drug), Fludarabine (Drug), Laboratory Biomarker Analysis (Other), Thiotepa (Drug), Total-Body Irradiation (Radiation)…→Cyclophosphamide (Drug), Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion (Biological), Fludarabine (Drug), Thiotepa (Drug), Total-Body…
Eligibility criteria-1,933 characters
Key Criteria: Inclusion Criteria: Patient must have hematologic malignancy [...] splant Malignancies included are: Acute leukemia, including Acuteacute 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., RAEB, RAEBt) or refractory anemia wit [...] [...]
Secondary endpoints5 to 6 entries
NeutrophilIncidence of CTCAE Grade >=3 Adverse Events within the first 24 hours after infusion Time to neutrophil engraftment PlateletTime engraftment measured by the number of participants with ato platelet count > 20,000/μl without subsequent transfusions for 7 daysengraftment Incidence of adversesevere eventsacute graft-versus-host disease (GVHD) NonIncidence of chronic graft-versus-host disease (GVHD) Incidence of non-relapse mortality Non-relapse mortality
Primary endpoints3 to 1 entries
Graft failure Incidence and severity of acute graft versus host disease (GVHD) Incidence and severity of chronic graft versus host disease (GVHD)failure
Study description-1,333 characters
PRIMARY OBJECTIVES: I. Primary graft failure/rejection as defined by no neutrophil recovery by day 45 (regardless of donor chimerism) or autologous recovery (neutrophil recovery but < 10% donor chimerism in blood and bone marrow [BM]) by day 45. SECONDARY OBJECTIVES: I. Examine the safety and toxici [...]
Study sitesdetails revised at 2 of 2 sites
Collaborators2 to 3 entries
Fred Hutchinson Cancer Center
Study title-46 characters
Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With AcuteHematologic Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic SyndromesMalignancies
2018-03-26
Study Status, Study Description, Arms and Interventions, Outcome Measures, Contacts/Locations v2
Start date2018-03-15→2018-05-15
Secondary endpoints5 entries, revised
[...] count > 20,000/μl without subsequent transfusions for 7 days. AdverseIncidence of adverse events
Primary endpoints3 entries, revised
Incidence and severity of acute graft versus host disease (GVHD)
Study description-11 characters
[...] receive either regimen A or regimen B. REGIMEN A: Patients (less18 than or equal tothrough 45 years old) receive fludarabine intravenously (IV) over 3 [...]
Study sites2 entries, revised
Memorial Sloan- Kettering Cancer Center
2018-01-12
Study Status, Arms and Interventions, Outcome Measures v1
Secondary endpointsdetails revised at 1 of 5 entries
2018-01-08
Original filing
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.
Trial Details
NCT Number NCT03399773
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: Nohla Therapeutics, Inc., National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)
Conditions Acute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Hematopoietic and Lymphoid Cell Neoplasm, Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts
Enrollment 31 participants
Start Date 2022-05-10
Primary Completion 2025-06-09 (estimated)
Study Completion 2027-04-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-10