A randomized phase II multicenter study to assess the tolerability and efficacy of the addition of ibrutinib to 10-day decitabine in UNFIT (i.e. HCT-CI >= 3) AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) patients aged >= 66 years.A study in the frame of the masterprotocol of parallel randomized phase II studies in UNFIT-older AML/high-risk MDS patients.
- Conditions
- Acute Myeloid Leukemia (AML), Myelodysplasia
- Registration Number
- NL-OMON19923
- Lead Sponsor
- HOVON Data Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 185
Patients with:
- a diagnosis of AML and related precursor neoplasms according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML, or
♦ Acute promyelocytic leukemia.
♦ Patients previously treated for AML (any antileukemic therapy including investigational agents), a short treatment period ( =< 5 days) with Hydroxyurea is allowed
♦ Diagnosis of any previous or concomitant malignancy is an exclusion criterion: except when the patient completed successfully treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 6 months prior to randomization.
♦ Blast crisis of chronic myeloid leukemia.
♦ Inability to discontinue any anti-coagulants (including ascal)
♦ Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etc.)
♦ Cardiac dysfunction as defined by:
- Myocardial infarction within the last 3 months of study entry, or
- Reduced left ventricular function with an ejection fraction < 40% as measured by MUGA scan or echocardiogram or
- Unstable angina or
- New York Heart Association (NYHA) grade IV congestive heart failure (see Appendix I) or
- Unstable cardiac arrhythmias
♦ Patient has had major surgery within the past 4 weeks or a major wound that has not fully healed.
♦ Vaccinated with live, attenuated vaccines within 4 weeks prior to randomization.
♦ History of stroke or intracranial hemorrhage within 6 months prior to randomization.
♦ Patient has a history of human immunodeficiency virus (HIV) or active infection with Hepatitis C or B.
♦ Patient has symptomatic central nervous system (CNS) leukemia (NO routinely lumbar puncture required to investigate CNS involvement)
♦ Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance.
♦ Patients with any serious concomitant medical condition which could, in the opinion of the investigator, compromise participation in the study.
♦ Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.
♦ Current concomitant chemotherapy, radiation therapy, or immunotherapy; other than hydroxyurea
♦ Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative CR/CRi rate after 3 cycles
- Secondary Outcome Measures
Name Time Method