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
Sponsor study identifier
interventional
163
1 country
22
Study Start
December 2014
Actual (reported)Primary Completion
September 22, 2017
Actual (reported)Study Completion
September 22, 2017
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 22, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 31, 2014
Actual (reported)November 4, 2014
Actual (reported)December 2014
Actual (reported)September 22, 2017
Actual (reported)September 22, 2017
Actual (reported)Duration of febrile episodes (fever)
42 days
Time to absolute neutrophil count (ANC) recovery
42 days
Incidence and duration of febrile neutropenia
42 days
Incidence and duration of infection
42 days
Dose escalation
Dose escalation
Randomized
Single intravenous infusion
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
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.
William Reed, MD
Cellerant Therapeutics
163 participants (actual enrollment reported by the registry).
First Submitted
October 31, 2014
First Posted
November 4, 2014
Study Start
December 2014
Actual (reported)Incidence and severity of mucositis
42 days
Incidence of infusion reactions
42 days
Randomized
Daily subcutaneous injections
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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
St 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
Primary Completion
September 22, 2017
Actual (reported)Study Completion
September 22, 2017
Actual (reported)Last Updated
September 27, 2018
Record last verified: 2018-09
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Source: ClinicalTrials.gov.
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