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| Title | A Phase I/II, Multi-centre Trial to Assess the Safety, Efficacy, and Pharmacokinetics of Eltrombopag, Administered to Thrombocytopenic Chronic Lymphocytic Leukemia Patients Prior to Alkylating Agents and/or Purine Analogue-based Therapy |
|---|---|
| Protocol IDs | EudraCT 2010-023022-20 NCT01397149 (30 June 2011) |
| Recruitment Status | prematurely terminated due to slow recruitment |
| Design | Phase I: Prospective, open-label, multicentre
single-arm dose-escalation study
Phase II: Prospective, randomised (eltrombopag:placebo = 2:1), double-blind, placebo-controlled multicentre study |
| Primary Objectives | Phase I: Determination of the safe and potentially efficacious dose of eltrombopag to achieve a durable increase in platelet count (≥100,000/μl) Phase II: Confirmation of the effect of the selected dose from Phase I in correcting thrombocytopenia to enable patients to receive alkylating agents and/or purine analogue-based therapy (platelet counts ≥100,000/μl prior to cycle 1 and platelet counts ≥75,000/μl in the subsequent 3 cycles). |
| Secondary Objectives |
• Safety and tolerability of eltrombopag • Incidence and durability of platelet response • Incidence and severity of bleeding events (assessed by WHO bleeding scale) • Pharmacokinetics and pharmacodynamics of eltrombopag • Effect of eltrombopag on the use of platelet transfusion(s) • Evaluation of chemotherapy dose delay/dose reduction in eltrombopag groups • Examination of the eltrombopag effect on thrombocytopenia • CLL overall response rate (ORR) and time to progression (TTP) of leukemia in subgroups • Evaluation of trough-level pharmacokinetics of eltrombopag • Evaluation of the influence of patients sex on relevant efficacy and safety parameters |
| Study Population |
• Confirmed diagnosis of CLL (based on immunophenotyping performed at the central reference laboratory of the GCLLSG in Cologne) • Platelet count <50 000/μl at time of screening (measured and confirmed once) • Patient is planned to receive alkylating agents, bendamustine and/or fludarabine-based therapy as 2nd or higher-line treatment • at least one prior CLL therapy • Patients are excluded from the study if their thrombocytopenia is primarily caused by idiopathic thrombocytopenic purpuraIdiopathic thrombocytopenic purpura (ITP) or if they have refractory CLL Age ≥ 18 years |
| Treatment | Phase I Dose-escalation of Eltrombopag p.o.: 75mg, 150mg, 225mg or 300mg daily for 2 weeks Phase II Feasible dose of Eltrombopag (determined in Phase I) or placebo will be administered before starting each cycle of chemotherapy and will continue during all cycles of treatment for a maximum of 6 months. |
| Patients recruited | 3 patients |
| Time schedule | Start of recruitment: 05/2012 Recruitment period: 15.05.2012 - 10.01.2013 |
| Protocol Version | 23 Mar 2011 Protocol (V 1.6) 24 Jan 2013 Amendment 1 (V 2.0) |
| Sponsor | Ulm University Hospital |
| Coordinating Investigator | Prof. Dr. Stephan Stilgenbauer, Dept of Internal Medicine III, Ulm University Hospital Ulm |
| Contact for public queries | Wissenchaftlicher Service Pharma (WiSP), Langenfeld |
| Contact for scientific queries | Prof. Dr. Stephan Stilgenbauer, Dept of Internal Medicine III, Ulm University Hospital |
| Documents (publicly available) |
Synopsis |
| Documents (password protected) |
Protocol, SAE Form and Pregnancy Reporting Form see Download Center |