Eltrombopag in Thrombocytopenic Chronic Lymphocytic Leukemia (CLL) Patients (CLL2S Study of GCLLSG)

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

November 30, 2013

Study Completion Date

November 30, 2014

Conditions
Chronic Lymphocytic LeukemiaThrombocytopenia
Interventions
DRUG

Placebo

Dosage form, frequency and duration exactly as experimental arm.

DRUG

Eltrombopag

"Phase I:~Single arm dose-escalation trial part, to test 4 doses of eltrombopag (75mg, 150mg, 225mg, 300mg) to find the appropriate, feasible dose to achieve a durable increase in platelet count (≥100,000/µl). Eltrombopag will be administered once daily at the respective dose level for 2 weeks (unless platelet counts rise to \> 400,000/µl).~Phase II:~Patients will be randomized (2:1 eltrombopag : placebo) to explore the efficacy and confirm the safety of the identified dose level from Phase I. Eltrombopag/placebo will be administered before starting each cycle (and possibly following chemotherapy treatment depending on data from phase I), and will continue during all cycles of treatment until subjects finish chemotherapy (alkylating agents and/or purine analogue-based therapy). The schedule and days of eltrombopag dosing in Phase II will be determined based on data analyzed from Phase I."

Trial Locations (10)

1090

Medizinische Universität Wien, Innere Medizin I, Abt. Hämatologie und Hämastaseologie, Vienna

15236

Klinikum Frankfurt (Oder) Medizinische Klinik I, Frankfurt (Oder)

24116

Universitätsklinikum Schleswig-Holstein, II. Medizinische Klinik und Poliklinik im Städtischen Krankenhaus, Kiel

26789

Onkologische Schwerpunktpraxis Leer-Emden, Leer

45147

Universitätsklinikum; Klinik für Hämatologie, Essen

50924

Universitätsklinikum Köln; Klinik I für Innere Medizin, Cologne

80804

Städtisches Klinikum München GmbH, Klinikum Schwabing, Klinik für Hämatologie, Immunologie, Palliativmedizin, Infektiologie und Tropenmedizin, München

89081

Universitätsklinikum Ulm, Medizinische Klinik III, Ulm

91052

Gemeinschaftspraxis für Innere Medizin, Hämatologie und Internistische Onkologie, Erlangen

01307

Universitätsklinikum Carl Gustav Carus Med. Klinik und Poliklinik I, Dresden

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

collaborator

German CLL Study Group

OTHER

collaborator

WiSP Wissenschaftlicher Service Pharma GmbH

OTHER

lead

University of Ulm

OTHER