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Acute Myeloid LeukemiaPhase 2NCT01035502

A Study of Elacytarabine (CP-4055) Plus Idarubicin as Second Course Remission-Induction Therapy in Patients With Acute Myeloid Leukaemia

A Phase 2 study testing Elacytarabine plus idarubicin in people with Acute Myeloid Leukemia, run by Clavis Pharma at 8 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective of this study is to assess the biological activity of elacytarabine in combination with idarubicin in patients with acute myeloid leukaemia who has failed the first course of a remission-induction treatment with cytarabine (ara-C). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Elacytarabine plus idarubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
8 sitesin 4 countries
Study dates
Dec 2009to Jun 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a confirmed diagnosis of AML according to WHO classification (excluding acute promyelocytic leukaemia)
  • Patients who have received one previous standard dose ara-C-containing regimen aiming at induction of complete remission (CR) and who have more than 5 % remaining blast cells in bone marrow following the first course of remission-induction or by other means documented residual disease (i.e. circulating blasts, persistent chloromas, other evident disease from day 12 on).
  • Patients from whom samples for determination of hENT1 status on leukemic blast cells can be taken and prepared at diagnosis and/or at baseline
  • Patients must be 18 years of age or older
  • Patients must have ECOG performance status (PS) of 0 - 2
  • Left ventricular ejection fraction (LVEF) must be >= 45 % as measured by MUGA scan or 2D ECHO within 14 days prior to start of therapy.
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  • Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study
  • 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
  • Patients must be capable of understanding and complying with parameters as outlined in the protocol, and able and willing to sign a written informed consent form
  • Patients must have the following clinical laboratory values:
  • Serum creatinine <= 1.5 x the institutional upper limit of normal (ULN)
  • Total bilirubin <= 1.5 x the ULN according to national prescribing information unless considered due to Gilbert's syndrome
  • Alanine aminotransferase (ALT) (SGPT), or aspartate aminotransferase (AST) (SGOT) <= 2.5 x the ULN unless considered due to organ leukemic involvement
  • Patients must be eligible for administration of idarubicin according to current national prescribing information for idarubicin

Who cannot join

  • A history of allergic reactions to egg, idarubicin and/or other anthracyclines or other components of the products. A history of allergic reactions to ara-C of CTCAE grade 3 or 4
  • Persistent clinically significant and relevant toxicities from the previous course of chemotherapy
  • A cancer history, that according to the investigator might confound the assessment of the study endpoints
  • Patients with prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 300 mg/m2 according to the following calculation index: X/300 + Y/160 < 1 where X is the doxorubicin or equivalent dose in mg/m2 and Y is the mitoxantrone dose in mg/m2. These calculations are to be used as guidance as there is no maximum cumulative dose defined in the summary of product characteristics (SPC) for idarubicin. The patient should tolerate minimum one course of combination therapy
  • Active heart disease including myocardial infarction within the previous 3 months, symptomatic coronary disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. Any NYHA grade 3 or 4
  • Known positive status for human immunodeficiency virus (HIV)
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  • Pregnant and nursing patients are excluded because the effects of elacytarabine on a fetus or a nursing child are unknown
  • Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, or psychiatric illness/social situations that may reduce compliance with study requirements
  • Patients receiving hydroxyurea within the last 12 hours prior to treatment on this protocol or any other investigational or standard cytotoxic treatment within the last 14 days, except the first remission-induction course
  • Any medical condition, which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities

Trial locations and contacts

8 sites in 4 countries.

8 sites in 4 countries

France3 sites

  • CHU Lyon, Hospital Edouard Herriot

    Lyon, 69437

  • Institut Paoli-Calmettes

    Marseille, 13273

  • CHU Toulouse, Hospital Purpan

    Toulouse, 31059

Other trials in France

Germany3 sites

  • Charite University Hospital Benjamin Franklin

    Berlin, 12200

  • Universitätsklinikum Münster

    Münster

  • Universitätsklinikum Ulm

    Ulm, D-89081

Other trials in Germany

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

Norway1 site

  • Haukeland University Hospital

    Bergen

Other trials in Norway

About this study

Official title: A Phase II Study of Elacytarabine (CP-4055) Plus Idarubicin as Second Course Remission-Induction Therapy in Patients With Acute Myeloid Leukaemia

The main objective of this study is to assess the biological activity of elacytarabine in combination with idarubicin in patients with acute myeloid leukaemia who has failed the first course of a remission-induction treatment with cytarabine (ara-C). In addition, the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival will be studied.

Read the detailed description

Elacytarabine (CP-4055) is a pro-drug of ara-C currently used in the treatment of patients with acute myeloid leukaemia. Patients with nucleoside transporter deficiency (hENT1) seem to have less benefit from cytarabine compared to those with a high expression of the transporter. Preclinical studies indicate that elacytarabine is independent of this transporter. Therefore, patients with low expression of hENT1 and treated with elacytarabine are anticipated to have a better outcome compared to patients treated with ara-C. The main objective of this study is to assess the biological activity of elacytarabine in combination with idarubicin in patients with acute myeloid leukaemia. In addition, the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival will be studied. Patients will be treated with elacytarabine plus idarubicin independent of their hENT1 status. Determination of the patients' hENT1 expression level will be done retrospectively. This study will also explore the safety profile of elacytarabine in combination with idarubicin.

Being tested
Elacytarabine plus idarubicin
Keywords
Cancer, CP-4055, elacytarabine, combination, idarubicin, Acute myeloid leukaemia (AML)
Medical subject headings
Leukemia, Myeloid, Acute, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elacytarabine plus idarubicinDrug

    Elacytarabine 1000 mg/m2/d will be administered as a continuous intravenous infusion (CIV) in a d 1-5 q3w cycle.

    Idarubicin will be administered IV at a fixed dose of 12 mg/ m2/d IV on d 1-3 q3w.

    It is intended that patients receive remission-induction treatment either as two combination courses, elacytarabine 1000 mg/m2/d + idarubicin 12 mg/m2/d or one combination course, elacytarabine 1000 mg/m2/d + idarubicin 12 mg/m2/d followed by one course elacytarabine 2000 mg/m2/d single therapy.

Study groups in NCT01035502
Study groupRoleWhat they receive
Elacytarabine plus idarubicinExperimentalNot described
Receives: Drug: Elacytarabine plus idarubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the rate of complete remission (CR), including complete remission with incomplete blood count recovery (CRi) in patients with AML who have not attained blast clearance after the first course of a ara-C based remission-induction therapy.

    Measured: Day 21 in each course

Secondary outcomes (4)

  1. Obtain indication on the independence between hENT1 expression level and CR or CRi. Obtain guidance on disease free survival (DFS). Obtain guidance on event free survival (EFS). Characterize the safety profile of elacytarabine plus idarubicin.

    Measured: Day 21 in each course

  2. Duration of disease free survival (DFS), defined as time from CR + CRi to relapse

    Measured: Study end

  3. Duration of event free survival (EFS), defined as time from day one of therapy until relapse or death from any cause

    Measured: Study end

  4. Characterize the safety profile of elacytarabine plus idarubicin in this patient population

    Measured: Study end

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionMay 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01035502
Sponsor's protocol ID
CP4055-205
Status last verified
Sep 2013
First submitted
15 Dec 2009
Last updated
27 Sep 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elacytarabine plus idarubicin in people with Acute Myeloid Leukemia, run by Clavis Pharma at 8 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France, Germany, United States, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the rate of complete remission (CR), including complete remission with incomplete blood count recovery (CRi) in patients with AML who have not attained blast clearance after the first course of a ara-C based remission-induction therapy. (time frame: Day 21 in each course). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01035502.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2013.

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