Safety and Efficacy of Human Myeloid Progenitor Cells (CLT-008) During Chemotherapy for Acute Myeloid Leukemia
NCT ID: NCT02282215
Last Updated: 2018-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
163 participants
INTERVENTIONAL
2014-12-31
2017-09-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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CLT-008 low dose with G-CSF
Dose escalation
CLT-008
Single intravenous infusion
G-CSF
Daily subcutaneous injections
CLT-008 high dose with G-CSF
Dose escalation
CLT-008
Single intravenous infusion
G-CSF
Daily subcutaneous injections
CLT-008 with G-CSF
Randomized
CLT-008
Single intravenous infusion
G-CSF
Daily subcutaneous injections
G-CSF
Randomized
G-CSF
Daily subcutaneous injections
Interventions
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CLT-008
Single intravenous infusion
G-CSF
Daily subcutaneous injections
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
Exclusion Criteria
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
55 Years
ALL
No
Sponsors
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Department of Health and Human Services
FED
Cellerant Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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William Reed, MD
Role: STUDY_DIRECTOR
Cellerant Therapeutics
Locations
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University of California San Diego Moores Cancer Center
La Jolla, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
University of California, San Francisco Medical Center
San Francisco, California, United States
UF Health Shands Cancer Hospital
Gainesville, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Northwestern Medical Faculty Foundation
Chicago, Illinois, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
The University of Chicago
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Indiana Blood and Marrow Transplantation Clinic
Indianapolis, Indiana, United States
University of Massachusetts Worcester
Worcester, Massachusetts, United States
University of Minnesota Physicians BMT Clinic
Minneapolis, Minnesota, United States
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
Countries
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References
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Desai PM, Brown J, Gill S, Solh MM, Akard LP, Hsu JW, Ustun C, Andreadis C, Frankfurt O, Foran JM, Lister J, Schiller GJ, Wieduwilt MJ, Pagel JM, Stiff PJ, Liu D, Khan I, Stock W, Kambhampati S, Tallman MS, Morris L, Edwards J, Pusic I, Kantarjian HM, Mamelok R, Wong A, Van Syoc R, Kellerman L, Panuganti S, Mandalam R, Abboud CN, Ravandi F. Open-Label Phase II Prospective, Randomized, Controlled Study of Romyelocel-L Myeloid Progenitor Cells to Reduce Infection During Induction Chemotherapy for Acute Myeloid Leukemia. J Clin Oncol. 2021 Oct 10;39(29):3261-3272. doi: 10.1200/JCO.20.01739. Epub 2021 Jun 22.
Related Links
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Cellerant Therapeutics CLT-008: Myeloid Progenitor Cells
Other Identifiers
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CLT008-03
Identifier Type: -
Identifier Source: org_study_id
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