Status:
COMPLETED
Safety and Efficacy of Human Myeloid Progenitor Cells (CLT-008) During Chemotherapy for Acute Myeloid Leukemia
Lead Sponsor:
Cellerant Therapeutics
Collaborating Sponsors:
Department of Health and Human Services
Conditions:
Acute Myeloid Leukemia
Neutropenia
Eligibility:
All Genders
55+ years
Phase:
PHASE2
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).
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 strateg...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2017
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT02282215
Start Date
December 1 2014
End Date
September 22 2017
Last Update
September 27 2018
Active Locations (22)
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1
University of California San Diego Moores Cancer Center
La Jolla, California, United States, 92093
2
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
3
University of California, San Francisco Medical Center
San Francisco, California, United States, 94143
4
UF Health Shands Cancer Hospital
Gainesville, Florida, United States, 32608