WHO ICTRP trial
Study for patients with leukemic cells in their bone marrow
EUCTR2014-001876-75-NL · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2014-001876-75-NL |
|---|---|
| Public title | Study for patients with leukemic cells in their bone marrow |
| Scientific title | A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral selinexor (KPT-330) to standard induction chemotherapy in AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) in patients aged >= 66 years . A study in the frame of the… |
| Primary sponsor | HOVON Foundation |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Belgium;Norway;Netherlands;Switzerland |
| Conditions | patients = 66 years 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… |
| Interventions | Product Name: selinexor (20 mg) Product Code: KPT-330 Pharmaceutical Form: Tablet INN or Proposed INN: selinexor Current Sponsor code: KPT-330 Other descriptive name: KPT-330 Concentration unit: mg milligram(s) Concentration type: equal… |
| Registration date | Aug 27, 2015 |
| Target size | 230 |
| Secondary IDs | HOVON103AMLSelinexor;MEC2015-521 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: