Safety and Efficacy of Human Myeloid Progenitor Cells (CLT-008) During Chemotherapy for Acute Myeloid Leukemia
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
1 other identifier
interventional
163
1 country
22
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2014
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2014
CompletedFirst Posted
Study publicly available on registry
November 4, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2017
CompletedSeptember 27, 2018
September 1, 2018
2.8 years
October 31, 2014
September 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of febrile episodes (fever)
42 days
Secondary Outcomes (8)
Time to absolute neutrophil count (ANC) recovery
42 days
Incidence and duration of febrile neutropenia
42 days
Incidence and duration of infection
42 days
Incidence and severity of mucositis
42 days
Incidence of infusion reactions
42 days
- +3 more secondary outcomes
Study Arms (4)
CLT-008 low dose with G-CSF
EXPERIMENTALDose escalation
CLT-008 high dose with G-CSF
EXPERIMENTALDose escalation
CLT-008 with G-CSF
EXPERIMENTALRandomized
G-CSF
ACTIVE COMPARATORRandomized
Interventions
Single intravenous infusion
Daily subcutaneous injections
Eligibility Criteria
You may qualify if:
- Acute myeloid leukemia arising de novo (per European LeukemiaNet)
- Treated with any established chemotherapy regimen based on either:
- +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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cellerant Therapeuticslead
- Department of Health and Human Servicescollaborator
Study Sites (22)
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
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
Related Publications (1)
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.
PMID: 34156898DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
William Reed, MD
Cellerant Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2014
First Posted
November 4, 2014
Study Start
December 1, 2014
Primary Completion
September 22, 2017
Study Completion
September 22, 2017
Last Updated
September 27, 2018
Record last verified: 2018-09