Clinical Trials /

Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Hematologic Malignancies

NCT03399773

Description:

This phase II trial studies the effect of ex vivo expanded cord blood progenitor cells (NLA101) on outcomes from single cord blood transplant for hematologic malignancies. 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. NLA101 is intended to support neutrophil engraftment and reduce GVHD following transplant.

Related Conditions:
  • Acute Biphenotypic Leukemia
  • Acute Leukemia
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Chronic Myeloid Leukemia
  • Myelodysplastic Syndromes
Recruiting Status:

Withdrawn

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Hematologic Malignancies
  • Official Title: Infusion of Off the Shelf Ex Vivo Expanded Cryopreserved Progenitor Cells (NLA101) in the Setting of Single Cord Blood Transplantation for Patients With Hematologic Malignancies

Clinical Trial IDs

  • ORG STUDY ID: 9910
  • SECONDARY ID: NCI-2017-02205
  • SECONDARY ID: 9910
  • SECONDARY ID: P30CA015704
  • SECONDARY ID: P50HL110787
  • NCT ID: NCT03399773

Conditions

  • Acute Biphenotypic Leukemia
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Chronic Myelogenous Leukemia
  • Myelodysplastic Syndromes

Interventions

DrugSynonymsArms
Ex-Vivo Expanded Cord Blood Progenitor Cell InfusionNLA101, DilanubicelTreatment (chemotherapy, TBI, NLA101)
CyclophosphamideTreatment (chemotherapy, TBI, NLA101)
FludarabineTreatment (chemotherapy, TBI, NLA101)
ThiotepaTreatment (chemotherapy, TBI, NLA101)

Purpose

This phase II trial studies the effect of ex vivo expanded cord blood progenitor cells (NLA101) on outcomes from single cord blood transplant for hematologic malignancies. 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. NLA101 is intended to support neutrophil engraftment and reduce GVHD following transplant.

Trial Arms

NameTypeDescriptionInterventions
Treatment (chemotherapy, TBI, NLA101)ExperimentalPatients receive either regimen A (High Dose TBI) or regimen B (Intermediate Dose). REGIMEN A: Patients (18 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 NLA101 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, thiotepa IV over 4 hours on days -5 and -4, and TBI on days -2 and -1. Patients receive unmanipulated cord blood unit IV followed by NLA101 IV within the next 24 hours on day 0.
  • Cyclophosphamide
  • Fludarabine
  • Thiotepa

Eligibility Criteria

        Key Criteria:

        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)

               -  Myelodysplasia (MDS)

               -  Chronic Myeloid Leukemia (CML)

          -  High dose TBI regimen: 18 to =< 45 years

          -  Intermediate intensity regimen: 18 to =< 65 years

          -  Karnofsky >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-1 (and non-age adjusted
             CI <=5 if >45 years)

          -  Adequate renal, hepatic, pulmonary, and cardiac function

          -  Ability to understand and the willingness to sign a written informed consent form

        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) consultant

          -  History of human immunodeficiency virus (HIV) infection

          -  Pregnant or breastfeeding

          -  Prior allogeneic transplant

          -  Central nervous system (CNS) leukemic involvement not clearing with intrathecal
             chemotherapy
      
Maximum Eligible Age:65 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of graft failure
Time Frame:Up to 45 days post-transplant
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence of CTCAE Grade >=3 Adverse Events within the first 24 hours after infusion
Time Frame:Up to 100 days post-transplant
Safety Issue:
Description:
Measure:Time to neutrophil engraftment
Time Frame:Up to 45 days post-transplant
Safety Issue:
Description:
Measure:Time to platelet engraftment
Time Frame:Up to 100 days post-transplant
Safety Issue:
Description:
Measure:Incidence of severe acute graft-versus-host disease (GVHD)
Time Frame:Up to 100 days post-transplant
Safety Issue:
Description:
Measure:Incidence of chronic graft-versus-host disease (GVHD)
Time Frame:Up to 2-years post-transplant
Safety Issue:
Description:
Measure:Incidence of non-relapse mortality
Time Frame:Up to 1-year post-transplant
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Nohla Therapeutics, Inc.

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