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Trial record 1 of 3 for:    Cellerant
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Safety and Efficacy of Human Myeloid Progenitor Cells (CLT-008) During Chemotherapy for Acute Myeloid Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02282215
First Posted: November 4, 2014
Last Update Posted: November 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Cellerant Therapeutics
  Purpose
The purpose of the study is to explore the safety and efficacy of CLT-008 as an extra supportive care measure after induction chemotherapy for patients with acute myeloid leukemia (AML).

Condition Intervention Phase
Acute Myeloid Leukemia Biological: CLT-008 Biological: G-CSF Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An Open-Label Phase 2 Prospective, Randomized, Controlled Study of CLT-008 Myeloid Progenitor Cells as a Supportive Care Measure During Induction Chemotherapy for Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by Cellerant Therapeutics:

Primary Outcome Measures:
  • Duration of febrile episodes (fever) [ Time Frame: 42 days ]

Secondary Outcome Measures:
  • Time to absolute neutrophil count (ANC) recovery [ Time Frame: 42 days ]
  • Incidence and duration of febrile neutropenia [ Time Frame: 42 days ]
  • Incidence and duration of infection [ Time Frame: 42 days ]
  • Incidence and severity of mucositis [ Time Frame: 42 days ]
  • Incidence of infusion reactions [ Time Frame: 42 days ]
  • Incidence of Graft-versus-Host Disease (GVHD) [ Time Frame: 42 days ]
  • Incidence of Adverse Events (AE) [ Time Frame: 42 days ]
  • Incidence of Serious Adverse Events (SAE) [ Time Frame: 42 days ]

Enrollment: 163
Actual Study Start Date: December 2014
Study Completion Date: September 22, 2017
Primary Completion Date: September 22, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CLT-008 low dose with G-CSF
Dose escalation
Biological: CLT-008
Single intravenous infusion
Other Names:
  • human allogeneic myeloid progenitor cells (hMPC)
  • romyelocel-L
Biological: G-CSF
Daily subcutaneous injections
Other Names:
  • Neupogen (filgrastim)
  • granulocyte colony-stimulating factor
  • Zarxio
  • Granix (tbo-filgrastim)
Experimental: CLT-008 high dose with G-CSF
Dose escalation
Biological: CLT-008
Single intravenous infusion
Other Names:
  • human allogeneic myeloid progenitor cells (hMPC)
  • romyelocel-L
Biological: G-CSF
Daily subcutaneous injections
Other Names:
  • Neupogen (filgrastim)
  • granulocyte colony-stimulating factor
  • Zarxio
  • Granix (tbo-filgrastim)
Experimental: CLT-008 with G-CSF
Randomized
Biological: CLT-008
Single intravenous infusion
Other Names:
  • human allogeneic myeloid progenitor cells (hMPC)
  • romyelocel-L
Biological: G-CSF
Daily subcutaneous injections
Other Names:
  • Neupogen (filgrastim)
  • granulocyte colony-stimulating factor
  • Zarxio
  • Granix (tbo-filgrastim)
Active Comparator: G-CSF
Randomized
Biological: G-CSF
Daily subcutaneous injections
Other Names:
  • Neupogen (filgrastim)
  • granulocyte colony-stimulating factor
  • Zarxio
  • Granix (tbo-filgrastim)

Detailed Description:
The prolonged period of severe neutropenia caused by induction chemotherapy for the treatment of AML is associated with a nearly universal risk of febrile neutropenia. Standard supportive care strategies include administration of prophylactic anti-bacterial and anti-fungal agents, but serious breakthrough bacterial and fungal infections still occur. Granulocyte colony-stimulating factor (G-CSF; filgrastim, Neupogen®) has been shown to shorten the duration of severe neutropenia, fever, antibiotic use and hospitalization following induction chemotherapy for AML. CLT-008, a human allogeneic myeloid progenitor cell product, is intended to provide the cellular target for G-CSF to produce neutrophils during the period of chemotherapy-induced bone marrow suppression when the patient's own progenitor cells may be limited in responding to G-CSF. It is hypothesized that the production of allogeneic neutrophils from CLT-008 will be sufficient to mitigate the infection-related consequences of induction chemotherapy for AML.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Acute myeloid leukemia arising de novo (per European LeukemiaNet)
  2. Treated with any established chemotherapy regimen based on either:

    1. 7+3: Standard-dose cytarabine 100-200 mg per meter squared continuous infusion for 7 days with idarubicin 12 mg per meter squared or daunarubicin 45-90 mg per meter squared for 3 days
    2. High-dose cytarabine-based (HIDAC) chemotherapy administering a total cytarabine dose of ≥ 4 g per meter squared alone or in combination with other anti-leukemic agents (for example, anthracyclines, purine nucleoside inhibitors, etoposide, etc.)
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening or by the day chemotherapy is initiated
  4. Adequate respiratory function with a room air oxygen saturation of at least 92%
  5. Adequate cardiac function defined as an ejection fraction of at least 45%
  6. Serum bilirubin ≤ 1.5 times the upper limits of normal. Subjects with a history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with an indirect bilirubin of > 1.5 mg/dL
  7. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times upper limits of normal prior to chemotherapy
  8. Serum creatinine ≤ 2 times upper limits of normal or estimated glomerular filtration rate ≥ 60 mL/min/1.73 meter squared per Modification of Diet in Renal Disease equation (MDRD)
  9. All subjects, except post-menopausal women, must be willing to utilize a highly effective method of contraception throughout the study
  10. Adequately informed of the nature and risks of the study with written informed consent

Exclusion Criteria:

  1. Pregnant or breast feeding
  2. Overt central nervous system manifestations of leukemia at diagnosis
  3. Specifically diagnosed and uncontrolled fungal, bacterial, viral, or other infection (e.g. confirmed sepsis, pneumonia, abscess, cellulitis, etc.) at the day chemotherapy is initiated. "Uncontrolled" is defined as exhibiting ongoing signs and symptoms of infection without improvement despite antimicrobial or other treatment.
  4. AML subtype M3 (promyelocytic leukemia)
  5. Previous chemotherapy for AML
  6. History of or current human immunodeficiency virus (HIV) or hepatitis C virus infection
  7. History of or current clinically significant immunodeficiency
  8. Known contraindication to receiving G-CSF
  9. History of or current clinically significant alloimmunization to leukocyte antigens
  10. Participation in another clinical study within 28 days of the day chemotherapy is initiated, in which the study drug or device may influence hematopoiesis. Co-enrollment in another study is allowed in cases where the investigational therapy under study is a version of an acceptable chemotherapy regimen for this study per the inclusion criteria.
  11. Receiving any agent concurrently with CLT-008 infusion which inhibits cell division (e.g., methotrexate or hydroxyurea)
  12. Acute or chronic medical disorder that, in the opinion of the investigator or medical monitor, may prevent the subject from completing participation in the study
  Contacts and Locations
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): NCT02282215


Locations
United States, California
University of California San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
University of California, San Francisco Medical Center
San Francisco, California, United States, 94143
United States, Florida
UF Health Shands Cancer Hospital
Gainesville, Florida, United States, 32608
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
United States, Illinois
Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
The University of Chicago
Chicago, Illinois, United States, 60637
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Indiana Blood and Marrow Transplantation Clinic
Indianapolis, Indiana, United States, 46237
United States, Massachusetts
University of Massachusetts Worcester
Worcester, Massachusetts, United States, 01655
United States, Minnesota
University of Minnesota Physicians BMT Clinic
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64128
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, United States, 10065
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 66215
Westchester Medical Center
Valhalla, New York, United States, 10595
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Cellerant Therapeutics
Department of Health and Human Services
Investigators
Study Director: William Reed, MD Cellerant Therapeutics
  More Information

Additional Information:
Responsible Party: Cellerant Therapeutics
ClinicalTrials.gov Identifier: NCT02282215     History of Changes
Other Study ID Numbers: CLT008-03
First Submitted: October 31, 2014
First Posted: November 4, 2014
Last Update Posted: November 16, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Cellerant Therapeutics:
Fever
Induction chemotherapy
Infection
Leukemia
Myeloid progenitor cells
Neutropenia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs