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CMMLPhase 1/2NCT02323178

A Study of Eltrombopag in Patients With CMML and Thrombocytopenia

A Phase 1/2 study testing eltrombopag in people with CMML and Thrombocytopenia, run by Groupe Francophone des Myelodysplasies at 26 sites in France.

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

Treatment of patients with chronic myelomonocytic leukemia (CMML) and thrombocytopenia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
CMML, Thrombocytopenia
What is being tested?
eltrombopag
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
26 sitesFrance
Study dates
7 Aug 2014to Apr 2021
Phase
Phase 1/2
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

  • Age 18 years or older
  • Chronic myelomonocytic leukemia (CMML) according to WHO criteria:
  • Stable excess in blood monocytes > 1 G/L
  • Lack of bcr-abl rearrangement (or Philadelphia chromosome)
  • Bone marrow blast cells < 20%
  • Dysplasia of at least one lineage or clonality marker or blood monocytosis during more than 3 months w/o other explanation
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  • Platelet counts < 50 G/L on two successive blood counts in the 2 weeks preceding inclusion
  • Either of D1 or D2 criteria:
  • Lack of features of advanced disease If white blood cell count (WBC) < 13 G/L: International Prognostic Scoring System (IPSS) low or intermediate-1
  • If WBC ≥ 13 G/L: no more than one of the following criteria:
  • Clonal cytogenetic abnormality other than t(5;12) (q33; p13)
  • Absolute neutrophil count (ANC) > 16 G/L
  • Anemia (Hb < 100 g/L)
  • Extramedullary localization (documented cutaneous, pleural or pericardial effusion, etc…) OR D2- Features of advanced disease If WBC < 13 G/L: IPSS intermediate-2 or high
  • If WBC ≥ 13 G/L: two or more of the following criteria:
  • Clonal cytogenetic abnormality other than t(5;12) (q33; p13)
  • ANC > 16 G/L
  • Anemia (Hb < 100 g/L)
  • Extramedullary localization (documented cutaneous, pleural or pericardial effusion, etc…) And having resisted (progression or stable disease without hematological improvement according to International Working Group (IWG) 2006 criteria) or relapsed after a treatment with a hypomethylating agent (azacitidine or decitabine for a minimum of 6 cycles)
  • Blast cells ≤ 5% in the bone marrow
  • Performance status 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale
  • Serum Creatinin < 2 times the upper limit of normal (ULN)
  • Alanine transaminase (ALT) and aspartate transaminase (AST) < 3 ULN, total bilirubin < 1.5 ULN (except Gilbert Syndrome)
  • Adequate contraception if relevant
  • Signed informed consent

Who cannot join

  • CMML with t(5 ;12) or Platelet-derived growth factor beta receptor (PDGFbetaR) rearrangement
  • Acute blastic transformation of CMML with bone marrow blast cells > 20%
  • Bone marrow blast cells > 5%
  • Patients eligible for allogeneic bone marrow transplantation with an identified donor
  • Intensive chemotherapy given less than 3 months before inclusion
  • Pregnant or breastfeeding
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  • Hepatitis C infection
  • Splenomegaly > 16 cm by ultrasound or CT scan (Not Applicable in patients without palpable splenomegaly)
  • Significant (grade II-IV) myelofibrosis (bone marrow trephine if bone marrow aspirate with poor cellularity, or features of myelofibrosis on the peripheral blood smear (teardrop erythrocytes)
  • Clinically relevant thromboembolic risk factor which, in the investigator's opinion, is such that the benefit/risk ratio becomes unfavourable if platelet counts increase
  • Liver cirrhosis (Child-Pugh score ≥ 5)
  • Prior Cancer (except in situ cervix carcinoma, limited basal cell carcinoma, or other tumors if not active during the last 3 years)
  • Serious concomitant systemic disorder, including active bacterial, fungal or viral infection that, in the opinion of the investigator, would compromise the safety of the patient and/or his/her ability to complete the study.
  • Hypersensitivity to Eltrombopag

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

France26 sites

  • CHU d'Amiens

    Amiens, 80054

  • CHU d'Angers

    Angers, 49 033

  • CH Victor Dupouy

    Argenteuil, 95107

  • Hôpital Avicenne

    Bobigny, 93009

  • Hôpital privé Sévigné

    Cesson-Sévigné, 35510

  • CHU Henri Mondor

    Créteil, 94010

  • CHU de Grenoble

    Grenoble, 38043

  • CH Le Mans

    Le Mans, 72037

  • CHRU de Limoges

    Limoges, 87046

  • Centre Hospitalier Lyon Sud

    Lyon, 69495

  • Institut Paoli Calmettes

    Marseille, 13009

  • Centre Hospitalier de Meaux

    Meaux, 77100

  • CHU de Nantes

    Nantes, 44093

  • Centre Catherine de Sienne

    Nantes, 44277

  • Hôpital Archet 1

    Nice, 06202

  • Hôpital Saint Louis - Service d'hématologie AJA

    Paris, 75010

  • Hôpital Saint Louis - Service d'hématologie séniors

    Paris, 75010

  • CHU de Haut-Lévèque

    Pessac, 33604

  • CHU de Poitiers

    Poitiers, 86021

  • Centre Hospitalier de la région d'Annecy

    Pringy, 74374

  • Hôpital Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

  • IUCT Oncopole - Médecine interne

    Toulouse, 31059

  • IUCT Oncopole - Service d'Hématologie Clinique

    Toulouse, 31059

  • CHU Brabois

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: A Phase I/II Study of Eltrombopag in Patients With Chronic Myelomonocytic Leukemia and Thrombocytopenia

Treatment of patients with chronic myelomonocytic leukemia (CMML) and thrombocytopenia.

Read the detailed description

All eligible patients will be treated with eltrombopag for a minimum of twelve weeks and a maximum of 24 months.

Being tested
eltrombopag
Keywords
Chronic myelomonocytic leukemia, thrombocytopenia, eltrombopag
Medical subject headings
Thrombocytopenia, Leukemia, Myelomonocytic, Chronic

What participants receive

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

  • eltrombopagDrug

    Also called revolade

    initial dose of 50 mg once daily, then the dose can be sequentially increased every 2 weeks up to a maximum dose of 300mg/day

Study groups in NCT02323178
Study groupRoleWhat they receive
eltrombopagExperimentalNot described
Receives: Drug: eltrombopag

What is being measured

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

  1. Platelet response

    Hematological improvement after twelve weeks of eltrombopag treatment

    Measured: 12 weeks

Secondary outcomes (1)

  1. Duration of platelet response

    Duration of platelet response at end of follow-up

    Measured: 30 months

Timeline

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

  1. First posted23 Dec 2014 (estimated)
  2. Study start7 Aug 2014
  3. Primary completionDec 2018
  4. Study completionApr 2021

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02323178
Sponsor's protocol ID
GFM-LMMC-Eltrombopag
Other IDs
2013-001779-19
Status last verified
Apr 2021
First submitted
26 May 2014
Last updated
20 Apr 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing eltrombopag in people with CMML and Thrombocytopenia, run by Groupe Francophone des Myelodysplasies at 26 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 25 inclusion and 14 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 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Platelet response (time frame: 12 weeks). 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 NCT02323178.

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 20 Apr 2021.

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