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 leukemiamyelodysplastic syndromes10024324
- Registration Number
- NL-OMON53140
- Lead Sponsor
- HOVO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 70
• 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 leukemia's of ambiguous lineage according to WHO 2008 or
- a diagnosis of refractory anemia with excess of blasts (MDS) and IPSS-R >
4.5
• Patients 66 years and older.
• Patients NOT eligible for standard chemotherapy, defined as HCT-CI >= 3.
OR patient NOT eligible for standard chemotherapy for other reasons (wish of
patient).
• WBC <= 30 x10^9/L (prior hydroxyurea allowed for a maximum of 5 days, stop 2
days before start decitabine treatment)
• Adequate renal and hepatic functions unless clearly disease related
• WHO performance status 0, 1 or 2
• Male patients must use an effective contraceptive method during the study and
for a minimum of 6 months after study treatment.
• Written informed consent.
• 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 anti-coagulants
• Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled
diabetes, infection, hypertension, pulmonary disease etc.)
• Cardiac dysfunction
• 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 <p>• Cumulative CR/CRi rate after 3 cycles</p><br>
- Secondary Outcome Measures
Name Time Method