Acute Myeloid Leukemia Clinical Trial

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

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).

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Acute myeloid leukemia arising de novo (per European LeukemiaNet)

Treated with any established chemotherapy regimen based on either:

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
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.)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening or by the day chemotherapy is initiated
Adequate respiratory function with a room air oxygen saturation of at least 92%
Adequate cardiac function defined as an ejection fraction of at least 45%
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
Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times upper limits of normal prior to chemotherapy
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)
All subjects, except post-menopausal women, must be willing to utilize a highly effective method of contraception throughout the study
Adequately informed of the nature and risks of the study with written informed consent

Exclusion Criteria:

Pregnant or breast feeding
Overt central nervous system manifestations of leukemia at diagnosis
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.
AML subtype M3 (promyelocytic leukemia)
Previous chemotherapy for AML
History of or current human immunodeficiency virus (HIV) or hepatitis C virus infection
History of or current clinically significant immunodeficiency
Known contraindication to receiving G-CSF
History of or current clinically significant alloimmunization to leukocyte antigens
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.
Receiving any agent concurrently with CLT-008 infusion which inhibits cell division (e.g., methotrexate or hydroxyurea)
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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

163

Study ID:

NCT02282215

Recruitment Status:

Completed

Sponsor:

Cellerant Therapeutics

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There are 22 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

163

Study ID:

NCT02282215

Recruitment Status:

Completed

Sponsor:


Cellerant Therapeutics

How clear is this clinincal trial information?

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