A randomized placebo-controlled phase 2 study of decitabine with or without eltrombopag in patients with acute myeloid leukemia =65 years of age not eligible for intensive chemotherapy

Phase 1

• Conditions: acute myeloid leukemiaAML; MedDRA version: 20.0Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003150-13-DE
• Lead Sponsor: Technische Universität Dresden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-29
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

• Newly diagnosed AML (including therapy-related or after antecedent MDS) other than APL according to WHO criteria, i.e. bone marrow aspirate or biopsy must contain =20% blasts of all nucleated cells or differential blood count must contain =20% blasts. In AML defined by cytogenetic aberrations according to WHO the proportion of blasts may be <20%
• Age = 65 years
• ECOG performance status 0-3
• Patients not eligible for intensive induction therapy
• Planned therapy with DAC
• Platelet count <75 Gpt/L taken within 4 weeks prior to randomization
• Signed Informed Consent
• Adequate liver function as assessed by the following laboratory requirements:
o Total bilirubin = 3 times the upper limit of normal (except for Gilbert’s Syndrome)
o ALT and AST = 3 times upper limit of normal

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 238

Exclusion Criteria

• Acute promyelocytic leukemia (APL)
• History of MDS or AML treatment with TPO-R agonists (Revolade, NPlate or other TPO-R agonists), hypomethylating agents or intensive chemotherapy
• NYHA stage = 2 due to heart insufficiency
• Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
• Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication
• Active and uncontrolled infections
• positive Human Immunodeficiency Virus (HIV) or positive Hepatitis B or C serology
• Patients unable to swallow medication
• Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to eltrombopag or DAC or excipients that contraindicate their participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified