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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01147939




Registration number
NCT01147939
Ethics application status
Date submitted
14/04/2010
Date registered
22/06/2010
Date last updated
27/09/2013

Titles & IDs
Public title
Study of Elacytarabine Versus Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia (AML)
Scientific title
A Randomised Phase III Study of Elacytarabine vs. Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia
Secondary ID [1] 0 0
CP4055-306
Universal Trial Number (UTN)
Trial acronym
CLAVELA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia (AML) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Elacytarabine
Treatment: Drugs - Investigator's Choice

Experimental: Elacytarabine -

Active Comparator: Investigator's Choice -


Treatment: Drugs: Elacytarabine
Elacytarabine 2000 mg/m2/d administered as a continuous intravenous infusion (CIV) in a d 1-5 q3w cycle.

Treatment: Drugs: Investigator's Choice
E.g. cytarabine single agent/combinations, hypomethylating agents, best supportive care (BSC)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
Until 300 events occur
Secondary outcome [1] 0 0
Remission rate
Timepoint [1] 0 0
Until 300 events occur
Secondary outcome [2] 0 0
Compare number of patients with adverse events (AEs) per study arm as a measure of safety and tolerability
Timepoint [2] 0 0
From first dose of study treatment, until 30 days after the last dose (for each patient)
Secondary outcome [3] 0 0
Characterize exposure-response relationships for measures of effectiveness and toxicity
Timepoint [3] 0 0
During the first course of elacytarabine

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2013
Sample size
Target
Accrual to date
Final
381
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Royal North Shore Hopsital - Sydney
Recruitment hospital [2] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Box Hill Hospital - Melbourne
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
2065 - Sydney
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
3128 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Colorado
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Louisiana
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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South Carolina
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United States of America
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Tennessee
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United States of America
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Wisconsin
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Belgium
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Brugge
Country [18] 0 0
Belgium
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Brussels
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Belgium
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Bruxelles
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Belgium
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Edegem
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Belgium
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Liège
Country [22] 0 0
Belgium
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Yvoir
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Canada
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Ontario
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France
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Limoges
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France
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Lyon
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France
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Marseilles
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France
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Nice
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France
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Paris
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France
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Pessac
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France
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Toulouse
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Düsseldorf
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Germany
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Mainz
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Germany
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Münster
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Germany
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Rostock
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Germany
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Stuttgart
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Germany
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Ulm
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Ireland
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Dublin
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Ireland
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Galway
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Italy
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Firenze
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Italy
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Genova
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Italy
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Milano
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Italy
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Napoli
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Italy
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Ravenna
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Italy
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Roma
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Norway
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Bergen
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Norway
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Oslo
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Norway
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Trondheim
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Poland
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Wroclaw
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Romania
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Bucharest
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Romania
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Cluj Napoca
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Romania
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Iasi
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Spain
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Badalona
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Spain
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Madrid
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Spain
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Palma de Mallorca
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Spain
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Pamplona
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Spain
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Salamanca
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Spain
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Valencia
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United Kingdom
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Scotland
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United Kingdom
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Bristol
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United Kingdom
State/province [62] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Clavis Pharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01147939
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Rizzieri, MD
Address 0 0
Duke University Medical Center, Durham, NC, USA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01147939