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A Randomized Placebo-controlled Phase 2 Study of Decitabine With or Without Eltrombopag in AML Patients

NCT02446145 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2024-03-29

No results posted yet for this study

Summary

Acute myeloid leukemia (AML) is a disease with a poor prognosis including a 5-year overall survival (OS) of app. 20% for the entire population. In particular, the outcome of elderly patients with AML is dismal and the majority of patients die within the first year after diagnosis. This is also because treatment options for elderly patients with AML significantly differ from patients of younger age. In fact, comorbid conditions are common among the elderly such as heart disease, renal insufficiency and vascular disease thus influencing the ability to withstand intensive therapy. Elderly patients are also more likely than younger patients to develop severe, life threatening infections during the course of treatment. In addition to infectious complications, hemorrhages due to severe thrombocytopenia are responsible for morbidity and mortality in a considerable amount of patients. Compared with younger AML patients, elderly individuals with AML display a higher incidence of poor-prognosis karyotypes, of a preceding myelodysplastic syndrome (MDS), and greater expression of proteins involved in intrinsic resistance to chemotherapeutic agents. As a result conventional anthracycline based chemotherapy is only infrequently used in patients above the age of 65 years. Based on a recent randomized trial (Kantarjian et al. 2012) low-intensity epigenetic therapy with decitabine (DAC) has become the first-line standard of care in most European countries including Germany. Nevertheless, even with this treatment the 1-year OS is approximately 30 % only. Furthermore, severe thrombocytopenia is a main side effect of this therapy and can prevent adequate continuation of treatment being crucially for treatment success. Supportive care with platelet transfusions is effective primarily only over short periods and often requires hospitalization and therefore lowers the quality of life of these patients in their palliative situation. Therefore, patients could benefit from an approach aiming at an increase of platelet counts through combined use of Azacitidine (AZA) or DAC with an oral thrombopoietin receptor agonist like eltrombopag (EPAG). This could allow for a better adherence to DAC/AZA therapy by preventing dose delays due to prolonged thrombocytopenia. Additionally, the potential antileukemic effect of EPAG could also be beneficial for these AML patients.

Conditions

Interventions

DRUG

Eltrombopag

Patients will receive EPAG in addition to their background standard treatment with Decitabine/Azacitidine \- concomitant medication: either Decitabine days 1-5 of each cycle: 20 mg/sqm i.v. over 30 minutes or Azacitidine (AZA) days 1-7 of each cycle: 75 mg/sqm s.c.

DRUG

Placebo

Patients will receive Placebo in addition to their background standard treatment with Decitabine/Azacitidine \- concomitant medication: either Decitabine days 1-5 of each cycle: 20 mg/sqm i.v. over 30 minutes or Azacitidine (AZA) days 1-7 of each cycle: 75 mg/sqm s.c.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Uwe Platzbecker, Prof. · Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2020-12-26
Completion
2023-01-25

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02446145 on ClinicalTrials.gov