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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2014 by Cellerant Therapeutics
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cellerant Therapeutics
ClinicalTrials.gov Identifier:
NCT02282215
First received: October 31, 2014
Last updated: NA
Last verified: October 2014
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to absolute neutrophil count (ANC) recovery [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • Incidence and duration of febrile neutropenia [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • Incidence and duration of infection [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • Incidence and severity of mucositis [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • Incidence of infusion reactions [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
  • Incidence of Graft-versus-Host Disease (GVHD) [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
  • Incidence of Adverse Events (AE) [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
  • Incidence of Serious Adverse Events (SAE) [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 146
Estimated Primary Completion Date: December 2016 (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
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
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
Active Comparator: G-CSF
Randomized
Biological: G-CSF
Daily subcutaneous injections
Other Names:
  • Neupogen (filgrastim)
  • granulocyte colony-stimulating factor

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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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. Infection within 14 days of day chemotherapy is initiated which requires systemic antibiotics, antifungals or antivirals
  4. AML subtype M3 (promyelocytic leukemia)
  5. Previous chemotherapy for AML
  6. History of malignancy requiring treatment other than surgery
  7. History of or current human immunodeficiency virus (HIV) or hepatitis C virus infection
  8. History of or current clinically significant immunodeficiency
  9. Known contraindication to receiving G-CSF
  10. History of or current clinically significant alloimmunization to leukocyte antigens
  11. Participation in another clinical study within 28 days of the day chemotherapy is initiated, in which the study drug or device may influence hematopoiesis
  12. Receiving any agent concurrently with CLT-008 infusion which inhibits cell division (e.g., methotrexate or hydroxyurea)
  13. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02282215

Contacts
Contact: Rod Van Syoc 650-232-2124 rvansyoc@cellerant.com
Contact: Alicia Wong 650-232-2320 awong@cellerant.com

Locations
United States, Indiana
Indiana Blood and Marrow Transplantation Clinic Not yet recruiting
Indianapolis, Indiana, United States, 46237
Principal Investigator: Luke P. Akard, MD         
Sponsors and Collaborators
Cellerant Therapeutics
Investigators
Study Director: William Reed, MD Cellerant Therapeutics
  More Information

Additional Information:
No publications provided

Responsible Party: Cellerant Therapeutics
ClinicalTrials.gov Identifier: NCT02282215     History of Changes
Other Study ID Numbers: CLT008-03
Study First Received: October 31, 2014
Last Updated: October 31, 2014
Health Authority: United States: Food and Drug Administration

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
Neoplasms by Histologic Type
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014