Study of Elacytarabine Versus Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia (AML) (CLAVELA)
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|ClinicalTrials.gov Identifier: NCT01147939|
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : September 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia (AML)||Drug: Elacytarabine Drug: Investigator's Choice||Phase 3|
The study investigates the new nucleoside analogue derivative, elacytarabine, as treatment for patients with relapsed or refractory Acute Myeloid Leukemia (AML). To be included in the study, patients must have failed to respond to two or three different therapies for AML, or have obtained remission but then relapsed within a relatively short period of time. Patients of age ≥ 65 with adverse cytogenetics can be included in the study after having received one and up to three previous induction/re-induction therapies.
Elacytarabine is an investigational drug which is not commercially available. It is the elaidic acid ester derivative of cytarabine. Cytarabine is routinely used in the treatment of patients with AML. A substantial portion of AML patients have a deficient uptake of cytarabine, often explained by lack of a transport protein (hENT1) in the leukemic cell membrane. Due to the elaidic acid (a naturally occurring fatty acid), cellular uptake of elacytarabine is independent of this transport protein.
Patients included in the study will be randomized to elacytarabine or control treatment. Since there is no standard therapy for relapsed or refractory AML, there is a list of 7 control treatments and the investigator has to choose one that is locked before randomization.
Elacytarabine is given as a continuous infusion over five days, followed by a rest period of minimum two weeks. Investigator's choice treatment is given according to the specific routine.
After each course response evaluation and a decision on further treatment will be made.
Repeated courses of elacytarabine and control treatment might be needed to attain and/or maintain complete remission or clinical benefit.
After the end of study treatment, all patients will be followed for relapse and survival.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||381 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Phase III Study of Elacytarabine vs. Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||June 2013|
Elacytarabine 2000 mg/m2/d administered as a continuous intravenous infusion (CIV) in a d 1-5 q3w cycle.
|Active Comparator: Investigator's Choice||
Drug: Investigator's Choice
E.g. cytarabine single agent/combinations, hypomethylating agents, best supportive care (BSC)
- Overall survival [ Time Frame: Until 300 events occur ]Time from date of randomisation until the date of death
- Remission rate [ Time Frame: Until 300 events occur ]
- Remission rate measured by overall response rate (ORR) (i.e. complete remission (CR) and complete remission with incomplete bone marrow recovery (CRi))
- Remission rate measured by CR
- Remission duration analysed using cumulative incidence of relapse (CIR) measured from date of CR or CRi
- Compare number of patients with adverse events (AEs) per study arm as a measure of safety and tolerability [ Time Frame: From first dose of study treatment, until 30 days after the last dose (for each patient) ]Summaries will include rates of occurrence of any AEs, rates of AEs by system organ classification (SOC),rates of discontinuation of study treatment due to AEs.
- Characterize exposure-response relationships for measures of effectiveness and toxicity [ Time Frame: During the first course of elacytarabine ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01147939
|Principal Investigator:||David Rizzieri, MD||Duke University Medical Center, Durham, NC, USA|
|Study Chair:||Francis J Giles, MD, PhD||Cancer Therapy & Reseach Center at the University of Texas Health Science Center San Antonio, TX, USA|