A Study of Eltrombopag in Patients With CMML and Thrombocytopenia
NCT ID: NCT02323178
Last Updated: 2021-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2014-08-07
2021-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Eltrombopag in Myelodysplastic Syndrome (MDS) Patients With Thrombocytopenia
NCT01286038
A Study to Assess the Ability of Eltrombopag to Induce Sustained Response Off Treatment in Subjects With ITP
NCT03524612
A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS)
NCT02158936
Eltrombopag for Thrombocytopenia in Patients With Relapsed Multiple Myeloma
NCT01484314
Eltrombopag for the Treatment of Thrombocytopenia Due to Low- and Intermediate Risk Myelodysplastic Syndromes
NCT02912208
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
eltrombopag
eltrombopag
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
eltrombopag
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Novartis
INDUSTRY
Groupe Francophone des Myelodysplasies
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Raphaël Itzykson, MD
Role: PRINCIPAL_INVESTIGATOR
Saint-Louis Hospital, Paris, France
Pierre Fenaux, MD, PHD
Role: STUDY_DIRECTOR
Saint-Louis Hospital, Paris, France
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU d'Amiens
Amiens, , France
CHU d'Angers
Angers, , France
CH Victor Dupouy
Argenteuil, , France
Hôpital Avicenne
Bobigny, , France
Hôpital privé Sévigné
Cesson-Sévigné, , France
CHU Henri Mondor
Créteil, , France
CHU de Grenoble
Grenoble, , France
CH Le Mans
Le Mans, , France
CHRU de Limoges
Limoges, , France
Centre Hospitalier Lyon Sud
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Centre Hospitalier de Meaux
Meaux, , France
CHU de Nantes
Nantes, , France
Centre Catherine de Sienne
Nantes, , France
Hôpital Archet 1
Nice, , France
Hôpital Saint Louis - Service d'hématologie AJA
Paris, , France
Hôpital Saint Louis - Service d'hématologie séniors
Paris, , France
CHU de Haut-Lévèque
Pessac, , France
CHU de Poitiers
Poitiers, , France
Centre Hospitalier de la région d'Annecy
Pringy, , France
Hôpital Pontchaillou
Rennes, , France
Centre Henri Becquerel
Rouen, , France
IUCT Oncopole - Médecine interne
Toulouse, , France
IUCT Oncopole - Service d'Hématologie Clinique
Toulouse, , France
CHU Brabois
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-001779-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GFM-LMMC-Eltrombopag
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.