Safety and Efficacy of Human Myeloid Progenitor Cells (CLT-008) During Chemotherapy for Acute Myeloid Leukemia
Conditions
Acute Myeloid Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
Fever, Induction chemotherapy, Infection, Leukemia, Myeloid progenitor cells, Neutropenia
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: CLT-008 Type: Biological
Name: G-CSF Type: Biological
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 55 Years
Gender: Both
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
Locations
University of California San Diego Moores Cancer Center
La Jolla, California, United States
Status: Recruiting
Northwestern Medical Faculty Foundation
Chicago, Illinois, United States
Status: Recruiting
Indiana Blood and Marrow Transplantation Clinic
Indianapolis, Indiana, United States
Status: Recruiting
University of Massachusetts Worcester
Worcester, Massachusetts, United States
Status: Recruiting
University of Minnesota Physicians BMT Clinic
Minneapolis, Minnesota, United States
Status: Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
West Penn Hospital
Pittsburgh, Pennsylvania, United States
Status: Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Start Date
December 2014
Sponsors
Cellerant Therapeutics
Source
Cellerant Therapeutics
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page