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Acute Myeloid LeukemiaPhase 2EPAG2015NCT03603795

Study Impact on Outcome of Eltrombopag in Elderly Patients with Acute Myeloid Leukemia Receiving Induction Chemotherapy

A Phase 2 study testing Eltrombopag in people with Acute Myeloid Leukemia, run by French Innovative Leukemia Organisation at 15 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Phase II randomized placebo-controlled study to assess the impact on outcome of Eltrombopag administered to elderly patients with Acute Myeloid Leukemia (AML) receiving induction chemotherapy. A phase II multicenter and randomized placebo-controlled study Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Eltrombopag
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
15 sitesFrance
Study dates
11 Oct 2018to 30 Jul 2026
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 60 years of age.
  • AML de novo, except AML 3 and AML 7.
  • AML with no adverse cytogenetic according to Medical Research Council (MRC) 2010 classification.
  • Subjects should be eligible for intensive chemotherapy by Daunorubicine, cytarabine, Lomustine.
  • Eastern Cooperative Oncology Group (ECOG) < 3 (appendix 1).
  • SORROR ≤ 3 (appendix 2).
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  • Adequate baseline organ function defined by the criteria below:
  • Total bilirubin ≤ 1.5 x Upper Limit of Normal (ULN) range except cases clearly not indicative of inadequate liver function
  • Alanine Aminotransferase (ALAT) and Aspartate Aminotransferase (ASAT) ≤ 3 x ULN
  • Creatinin ≤ 1.5 x ULN
  • Adequate cardiac function with Left Ventricular Ejection fraction (LVEF) ≥50%
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  • Women will be menopausal to be enrolled
  • The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means assessment or evaluation that would not form part of the normal medical care of the patient and before the start of induction chemotherapy.
  • Affiliated to the French Social Security (Health Insurance).

Who cannot join

  • Subjects with a diagnosis of acute promyelocytic (M3) or megakaryocytic leukemia (M7).
  • AML with adverse cytogenetic according to the MRC 2010 classification.
  • AML secondary to Myelodysplastic syndrome (MDS), Myeloproliferative neoplasm (MPN)
  • Clinical symptoms suggesting active central nervous system leukemia, or presence of extramedullary AML.
  • Previous exposure to anthracycline.
  • Previous AML treatment other than hydroxyurea.
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  • Treatment with an investigational drug within 30 days or 5 half-life whichever is longer, preceding the first dose of study medication.
  • History of thromboembolic event or other condition requiring ongoing use of anticoagulation either with warfarin or low molecular-weight heparin.
  • History of another malignancy within the past three years except basal cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Pre-existing cardiovascular disease (including congestive heart failure, New York Heart Association (NYHA) Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation), or subjects with a QTc >450 msec (QTc >480 msec for subjects with Bundle Branch Block).
  • Patient requiring platelets transfusion with platelets > 10 x 10 Giga/L, for whatever reason.
  • History of treatment with romiplostim or other Thrombopoietin receptor (TPO-R) agonists.
  • Uncontrolled active infection.
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would place the participant at an unacceptable risk or prevent them from giving informed consent.
  • Known active HIV, Hepatitis B or C infection.
  • Pregnancy or breastfeeding.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • CHU ANGERS - Maladies du sang

    Angers, 49933

  • CH de la Côte Basque - Hématologie

    Bayonne, 64109

  • CHU Estaing

    Clermont-Ferrand, 63003

  • CHU Grenoble - Hématologie Clinique

    Grenoble, 38043

  • Institut Paoli-Calmettes - Hématologie 2

    Marseille, 13000

  • Hôpital Saint-Eloi - Hématologie Clinique

    Montpellier, 34295

  • HOPITAL E. MULLER - Hématologie

    Mulhouse, 68070

  • CHU HOTEL DIEU - Hématologie Clinique

    Nantes, 44093

  • CHU Caremeau

    Nîmes, 30029

  • CHU La Milétrie - Hématologie Clinique

    Poitiers, 86000

  • CHU Pontchaillou

    Rennes, 35033

  • CHU Hautepierre - Hématologie

    Strasbourg, 67098

  • Institut Universitaire du Cancer de Toulouse Oncopole - Service d'Hématologie

    Toulouse, 31059

  • Sponsor FILO

    Tours, 37044

  • CHU de Brabois

    Vandœuvre-lès-Nancy, 54500

Other trials in France

About this study

Official title: A Phase II Randomized Placebo-controlled Study to Assess the Impact on Outcome of Eltrombopag Administered to Elderly Patients with Acute Myeloid Leukemia Receiving Induction Chemotherapy

Phase II randomized placebo-controlled study to assess the impact on outcome of Eltrombopag administered to elderly patients with Acute Myeloid Leukemia (AML) receiving induction chemotherapy. A phase II multicenter and randomized placebo-controlled study

Read the detailed description

Subjects will be randomized 1:1 to receive Eltrombopag or matching placebo, in double blinded.

To compare overall survival rate at 12 months between the two arms, with or without 200 mg of Eltrombopag daily after induction chemotherapy

Arm A : Eltrombopag 200 mg (100 mg/day for east Asian heritage) once daily from day 11 of induction chemotherapy to AML response evaluation or platelets count > 100 x 10 Giga/L (maximum day 45)

Arm B : Placebo once daily from day 11 of induction chemotherapy to AML response evaluation or platelets count > 100 x 10 Giga/L. (maximum day 45)

Being tested
Eltrombopag, Placebo
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • EltrombopagDrug

    Also called Arm Eltrombopag, Arm experimental A

    Eltrombopag concomitant with induction chemotherapy in patient with AML

  • PlaceboDrug

    Also called Arm placebo, Arm B

    Placebo concomitant with induction chemotherapy patients with AML

Study groups in NCT03603795
Study groupRoleWhat they receive
AExperimental55 patients will be randomized in the experimental arm A. If platelets counts < 100 x 10 Giga/L, patients will be treated with Eltrombopag 200 mg/day per os from day 11 of induction chemotherapy to platelets counts > 100 x 10 Giga/L or maximum to day 45. If platelets counts ≥ 100 x 10 Giga/L on day 11, the start of IP will be delayed until platelets < 100 x 10 Giga/L. Chemotherapy administration would be performed among standard practice: * Daunorubicin: 60 mg/m² D1 to D3 * Cytarabine: 100 mg/m²/day, in a continuous 24h-IV infusion D1 to D7 * Lomustine (CCNU): 200 mg/m² per os, at D1. 200mg = 4 Tablets of 50 mg will be done more than 2 hours before Daunorubicin and cytarabine administrations, to avoid vomiting secondary to anthracycline administration. Investigational Product (IP) will be taken at the same time daily on an empty stomach 1 hour before or 2 hours after a meal or preferably no calcium or dairy products.
Receives: Drug: Eltrombopag
BPlacebo comparator55 patients will be randomized in the comparator arm B and will received: Placebo once daily from day 11 of induction chemotherapy to AML response evaluation or platelets count > 100 x 10 Giga/L (maximum day 45) Placebo 200mg = 4 Tablets of 50 mg will be done more than 2 hours before Daunorubicin and cytarabine administrations, to avoid vomiting secondary to anthracycline administration. Chemotherapy administration would be performed among standard practice: * Daunorubicin: 60 mg/m² D1 to D3 * Cytarabine: 100 mg/m²/day, in a continuous 24h-IV infusion D1 to D7 * Lomustine (CCNU): 200 mg/m² per os, at D1.
Receives: Drug: Placebo

What is being measured

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

  1. Overal survival rate

    overall survival rate at month 12 (year 1) between the two arms, with or without 200 mg of Eltrombopag daily after induction chemotherapy.

    Measured: 12 months after beginning treatment

Secondary outcomes (5)

  1. Response rate (CR and CRi) at day 45

    Measured: At day 45

  2. Leukemia Free Survival at month 12 (one year)

    relapse measurement before month 12

    Measured: 12 months after beginning treatment

  3. Long-term survival

    Overall survival at 2, 3 and 5 years

    Measured: 2, 3 and 5 years after first treatment administration

  4. Percentage of patients with platelets count > 100 Giga/L at day 45

    platelets count >100 Giga/L

    Measured: At day 45

  5. Time to platelet transfusion independence

    More than 3 days with platelets count ≥ 10 Giga/L

    Measured: platelets count daily from baseline to the end of induction (day 45) and then at day 60, day 90, monthly until year 1 and finally at year 2, year 3 and year 5

Timeline

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

  1. First posted27 Jul 2018
  2. Study start11 Oct 2018
  3. Primary completion15 Jun 2022
  4. Study completion30 Jul 2026 (estimated)

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
Randomised
Intervention model
Parallel groups
Model description
Randomization between 2 arms
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03603795
Sponsor's protocol ID
EPAG 2015
Acronym
EPAG2015
Status last verified
Oct 2024
First submitted
20 Apr 2018
Last updated
29 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eltrombopag in people with Acute Myeloid Leukemia, run by French Innovative Leukemia Organisation at 15 sites in France.

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 15 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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?

Overal survival rate (time frame: 12 months after beginning treatment). 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 NCT03603795.

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 29 Oct 2024.

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