WHO ICTRP trial
A randomized phase II multicenter study to assess the tolerability and efficacy…
NL-OMON19923 · Overview of Medical Research in the Netherlands (NL-OMON) · Recruiting
Key facts
| Trial ID | NL-OMON19923 |
|---|---|
| Public title | 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. |
| Scientific title | 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… |
| Primary sponsor | HOVON Data Center |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Conditions | Acute Myeloid Leukemia (AML), Myelodysplasia |
| Interventions | Patients in this study are treated with 10-day decitabine treatment with or without ibrutinib. The starting dose of ibrutinib will be 560 mg once daily. During the part A run-in phase the dose level of ibrutinib will be established. |
| Registration date | Sep 6, 2016 |
| Target size | 185 |
| Secondary IDs | NL5751;NTR6017;2015-002855-85 : HO135 |
| Registry page | onderzoekmetmensen.nl |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: