Study of Elacytarabine Versus Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia (AML)

Completed · Phase 3

Conditions studied: Acute Myeloid Leukemia (AML)

In brief

The purpose of the study is to assess the efficacy and safety of elacytarabine versus investigator's choice treatment in patients with relapsed or refractory acute myeloid leukemia (AML).

Key facts

Study ID

NCT01147939

Run by

Clavis Pharma

People needed

381

Starts

2010-06-01

Expected to finish

2013-06-01

Last updated by the study team

2013-09-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• Confirmed diagnosis of AML according to WHO classification (excluding acute promyelocytic leukaemia) who have received two or three previous induction/re-induction regimens or patients of age ≥ 65 with adverse cytogenetics who have received 1-3 previous induction/re-induction regimens. One of the (re-)induction regimens could be stem cell transplantation (SCT) for achievement of remission. Maintenance and consolidation (including SCT) may have been given, but are not counted as previous regimens.
• Bone marrow aspirates and/or biopsies must contain > 5 % leukaemic blast cells or patient must have biopsy-proven extramedullary AML, or patient's peripheral blood shows occurrence of leukaemic blast cells
• Patients must
• have never attained CR or CRi (primary refractory), or
• have failed initial induction therapy, and have attained CR or CRi after salvage therapy(ies), and then relapsed within < 6 months, or
• have attained CR or CRi after initial induction therapy and relapsed within <12 months, and failed to respond to salvage therapy(ies), or
• have relapsed after the latest CR or CRi within < 6 months
• Patients younger than 65 years should have received previous treatment with cytarabine
• Patients must have recovered from previous bone marrow and/or stem cell transplantation to a stage that the patient can tolerate the study treatment. There is no restriction on number of regimens or type of treatment administered for maintenance or consolidation during previous stages of the disease
• ECOG performance status (PS) of 0 - 2
• Women of child-bearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to treatment start
• Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last elacytarabine dose
• Capable of understanding and complying with protocol requirements, and must be able and willing to sign a written informed consent form

You may not qualify if…

• A history of allergic reactions to egg. A history of allergic reactions of CTCAE grade 3 or 4 to cytarabine
• Persistent clinically significant toxicities from previous chemotherapy
• A cancer history that, according to the investigator, might confound the assessment of the study endpoints
• Known positive status for human immunodeficiency virus (HIV)
• Pregnant and nursing patients
• Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements
• Impairment of hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into this clinical study
• Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. Any New York Heart Association (NYHA) functional classification grade 3 or 4
• Applicable only for patients for whom an anthracycline is part of the selected control treatment: Left ventricular ejection fraction (LVEF) must be ≥ 45 % as measured by MUGA scan or 2D ECHO within 14 days prior to start of therapy. Either method is acceptable for measuring LVEF
• Applicable only for patients for whom an anthracycline is part of the selected control treatment: The patient should tolerate minimum one course of combination therapy
• Any anti-leukaemic agents within the last 3 weeks. Hydroxyurea,however, is allowed for up to 12 hours prior to study treatment
• Any investigational treatment within the last 14 days
• Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities

Where it is running

• USC/Norris Comprehensive Cancer Center and Hospital — Los Angeles, California, United States
• UCLA School of Medicine, Division of Hematology/Oncology — Los Angeles, California, United States
• Rocky Mountain Blood and Bone Marrow Transplant Program — Denver, Colorado, United States
• Shands at the University of Florida — Gainesville, Florida, United States
• Winship Cancer Institute at Emory — Atlanta, Georgia, United States
• The Blood and Marrow Transplant Group of GA — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• St. Francis Hospital and Health Center — Indianapolis, Indiana, United States
• University of Iowa Hopsitals — Iowa City, Iowa, United States
• LSU Health Sciences Center, — Shreveport, Louisiana, United States
• Northern New Jersey Cancer Associates — Hackensack, New Jersey, United States
• New York Presbyterian Hospital, Weill-Cornell Medical College — New York, New York, United States
• Memorial Sloan-Kettering — New York, New York, United States
• New York Medical College — Valhalla, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Forest University, Health Sciences Section on Hematology and Oncology — Winston-Salem, North Carolina, United States
• The Jewish Hospital — Cincinnati, Ohio, United States
• Western Pennsylvania Hospital — Pittsburgh, Pennsylvania, United States
• St. Francis Hospital — Greenville, South Carolina, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Froedtert Hospital, Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Royal North Shore Hopsital — Sydney, New South Wales, Australia
• Alfred Hospital — Melbourne, Victoria, Australia
• Scripps Cancer Center Clinical Research — La Jolla, California, United States

Full record on ClinicalTrials.gov

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