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

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ClinicalTrials.gov Identifier: NCT03399773
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : October 3, 2018
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Nohla Therapeutics, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Biphenotypic Leukemia Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Chronic Myelogenous Leukemia Myelodysplastic Syndromes Biological: Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion Drug: Cyclophosphamide Drug: Fludarabine Drug: Thiotepa Radiation: Total-Body Irradiation Procedure: Umbilical Cord Blood Transplantation Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : August 2021


Arm Intervention/treatment
Experimental: Treatment (chemotherapy, TBI, NLA101)

Patients 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.

Biological: Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion
Given IV
Other Names:
  • NLA101
  • Dilanubicel

Drug: Cyclophosphamide
Given IV

Drug: Fludarabine
Given IV

Drug: Thiotepa
Given IV

Radiation: Total-Body Irradiation
Undergo TBI

Procedure: Umbilical Cord Blood Transplantation
Given IV




Primary Outcome Measures :
  1. Incidence of graft failure [ Time Frame: Up to 45 days post-transplant ]

Secondary Outcome Measures :
  1. Incidence of CTCAE Grade >=3 Adverse Events within the first 24 hours after infusion [ Time Frame: Up to 100 days post-transplant ]
  2. Time to neutrophil engraftment [ Time Frame: Up to 45 days post-transplant ]
  3. Time to platelet engraftment [ Time Frame: Up to 100 days post-transplant ]
  4. Incidence of severe acute graft-versus-host disease (GVHD) [ Time Frame: Up to 100 days post-transplant ]
  5. Incidence of chronic graft-versus-host disease (GVHD) [ Time Frame: Up to 2-years post-transplant ]
  6. Incidence of non-relapse mortality [ Time Frame: Up to 1-year post-transplant ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399773


Contacts
Contact: Richie Phan 206-519-5318 RichieP@nohlatherapeutics.com

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Nohla Therapeutics, Inc.
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Filippo Milano Fred Hutch/University of Washington Cancer Consortium

Responsible Party: Nohla Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03399773     History of Changes
Other Study ID Numbers: 9910
NCI-2017-02205 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9910 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
P50HL110787 ( U.S. NIH Grant/Contract )
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Biphenotypic, Acute
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Cyclophosphamide
Fludarabine phosphate
Thiotepa
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action