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Safety and Efficacy of Human Myeloid Progenitor Cells (CLT-008) During Chemotherapy for Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT02282215
Recruitment Status : Completed
First Posted : November 4, 2014
Last Update Posted : September 27, 2018
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Cellerant Therapeutics

Tracking Information
First Submitted Date  ICMJE October 31, 2014
First Posted Date  ICMJE November 4, 2014
Last Update Posted Date September 27, 2018
Actual Study Start Date  ICMJE December 2014
Actual Primary Completion Date September 22, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2014)
Duration of febrile episodes (fever) [ Time Frame: 42 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02282215 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Human Myeloid Progenitor Cells (CLT-008) During Chemotherapy for Acute Myeloid Leukemia
Official Title  ICMJE 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
Brief Summary 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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Acute Myeloid Leukemia
  • Neutropenia
  • Infection
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Experimental: CLT-008 low dose with G-CSF
    Dose escalation
    Interventions:
    • Biological: CLT-008
    • Biological: G-CSF
  • Experimental: CLT-008 high dose with G-CSF
    Dose escalation
    Interventions:
    • Biological: CLT-008
    • Biological: G-CSF
  • Experimental: CLT-008 with G-CSF
    Randomized
    Interventions:
    • Biological: CLT-008
    • Biological: G-CSF
  • Active Comparator: G-CSF
    Randomized
    Intervention: Biological: G-CSF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2017)
163
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2014)
146
Actual Study Completion Date  ICMJE September 22, 2017
Actual Primary Completion Date September 22, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 daunorubicin 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02282215
Other Study ID Numbers  ICMJE CLT008-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Cellerant Therapeutics
Study Sponsor  ICMJE Cellerant Therapeutics
Collaborators  ICMJE Department of Health and Human Services
Investigators  ICMJE
Study Director: William Reed, MD Cellerant Therapeutics
PRS Account Cellerant Therapeutics
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP