An overview of current CLL clinical trials in Europe

Transcription

1 An overview of current CLL clinical trials in Europe CENTER/GROUP TRIAL SITUATION CONTACT PERSONS OTHER REMARKS INFORMATION LAST Europewide Nordic-Dutch-Polish- Czech-Israeli Czech Republic Czech Leukemia Study Group for Life (CELL) France Sponsor = ROCHE GA101 in CD20+ malignancies French Intergroup on CLL (FCGCLL-WM & GOELAMS) French Intergroup on CLL (FCGCLL-WM & GOELAMS) HOVON68 (HOVON and Nordic Group) CLL Trial: AFC vs FC front-line in CLL biological high-risk Ofatumumab Added to Dexamethasone in Therapy of Relapsed or Refractory CLL Patients. Phase II Study. NCT : phase I/II of the anti-cd20 GA101 (R7159) in relapsed/refractory CD20+ CLL patients LLC 2007 SA : randomized phase III study of rituximab maintenance versus observation after FCR induction in previously untreated pts > 65 yrs CLL 2010 FMP : randomized phase II evaluating a prephase with high dose rituximab before FCR (versus standard dose FCR) in previously untreated pts < 65 yrs Completed 2010, 218 patients randomized First data presented at ASH Publication expected 2012 Phase II Trial. Ongoing. Phase I and II completed (France + Germany ) Ongoing Ongoing Feb 2012: 384 patients included New proposal for total of 458 patients Ongoing 140 pts expected activation july 2011 : 66 patients included Dr Christian Geisler Christian.geisler@rh.dk Phone: Dr. Michael Doubek, mdoubek@fnbrno.cz, University Hospital Brno, Jihlavska 20, CZ (Alemtuzumab low-dose) pavel.pisa@roche.com Dr Caroline Dartigeas cdartigeas@chu-tours.fr Dr Eric Van Den Neste vandenneste@sang.ucl.ac. be Dr Guillaume Cartron g-cartron@chumontpellier.fr Dr Stéphane Leprêtre slepretre@rouen.fnclcc.fr

2 French Intergroup on CLL (FCGCLL-WM & GOELAMS) To be initiated Q Pick the winner design French Intergroup on CLL (FCGCLL-WM & GOELAMS) ILLC-01 : randomized study comparing chlorambucil, low dose FC, ofatumumab monotherapy, FO (fludarabine + ofatumumab) and BO (bendamustine + ofatumumab) in elderly pts with untreated CLL ILLC-02 / BOMP : phase II trial of bendamustine, ofatumumab and methylprednisolone in fit pts with relapsed or refractory CLL To be initiated Q pts planned Dr Vincent Lévy vincent.levy@avc.aphp.fr Dr Xavier Troussard troussard-x@chu-caen.fr Dr Olivier Tournilhac otournilhac@chuclermontferrand.fr Dr Sophie De Guibert sophie.deguibert@churennes.fr Germany GCLLSG in cooperation with FCLLSG (CLL2O) GCLLSG in cooperation with FCGCLL (CLL7) A prospective, multicenter phase II study of subcutaneous alemtuzumab combined with oral dexamethasone, followed by alemtuzumab maintenance or allogeneic stem-cell transplantation, in chronic lymphocytic leukemia which is associated with 17p deletion or is refractory to fludarabine Randomized phase III trial comparing early treatment with fludarabine, Recruitment completed in December 2011 Recruitment completed Follow up onging until 2015 Data analyses in process Prof. Dr. Stephan Stilgenbauer Stephan.Stilgenbauer@un iklinik-ulm.de or GCLLSG webpage Prof. Dr. Michael Hallek michael.hallek@unikoeln.de

3 cyclophosphamide + rituximab versus deferred treatment in untreated Binet stage A patients with high risk of progression GCLLSG (CLL10) GCLLSG (CLL2P) Universitätsklinikum Ulm (Ulm University Hospital, Ulm, Germany), represented by the Vorsitzende des Klinikumsvorstandes (Chairman of the board) (CLL2S) Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FCR) versus Bendamustine and Rituximab (BR) in patients with previously untreated chronic lymphocytic leukaemia A phase I/II safety and efficacy trial of a combination of bendamustine, rituximab and lenalidomide (BRL) in patients with relapsed or refractory chronic lymphocytic leukemia 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 Recruitment completed Follow up ongoing Active Active PD Dr. Barbara Eichhorst barbara.eichhorst@ukkoeln.de Prof. Dr. Clemens-Martin Wendtner Prof. Dr. Stephan Stilgenbauer Stephan.Stilgenbauer@un iklinik-ulm.de

4 GCLLSG in cooperation with Hoffmann-La Roche (CLL11) An open-label, multicenter, three arm randomized, phase III study to compare the efficacy and safety of RO chlorambucil (GClb), rituximab + chlorambucil (RClb) or chlorambucil (Clb) alone in previously untreated CLL patients with comorbidities. Active Recruitment near completion Dr. Valentin Goede valentin.goede@ukkoeln.de GCLLSG (CLLM1) Italy ITALIAN MULTICENTER STUDY Coordinated by: Divisions of Hematology Hospital Milano Molinette Hospital Torino Hospital Milano A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of lenalidomide (Revlimid ) as maintenance therapy for high-risk patients with chronic lymphocytic leukemia following first-line therapy Bendamustine plus Campath as salvage regimen (Phase I and Phase II) Lenalidomide plus Campath as consolidation in responder pts after a salvage regimen (Dose finding) To be initiated Q Prof. Dr. Michael Hallek michael.hallek@unikoeln.de Ongoing in Phase II Dr Marco Montillo, Hospital Milano. marco.montillo@ospedale niguarda.it Momentarily interrupted Dr Marco Montillo, Hospital Milano. marco.montillo@ospedale July 2011 July 2011

5 niguarda.it ITALIAN MULTICENTER STUDY Coordinated by Hospital Milano Israel Israel CLL Study Group (ICLLSG) Kaplan Medical Center Israel Pentostatin plus Cyclophosphamide plus Ofatumumab in Previously untreated fit elderly patients ICLLSG 001 Phase II low dose FC in elderly CLL NCT Phase I-II Milatuzumab ( anti CD74) for refractory CLL Wolfson Health Gov Israel Phase II Fresh Frozen Plasma(FFP) and Rituximab For advanced refractory CLL Netherlands HOVON/NORDIC CLL group HOVON/NORDIC CLL group HOVON 68: FC versus FCA in high risk previously untreated CLL HOVON 101/GSK OMB :Ofatumum ab vs observation in relapsed CLL in CR/PR after a maximum of 3 regimens Ongoing Starting Dec 2009/Jan patients Expected completion 2012 April patients Expected completion 2012 January patients Expected completion 2012 Completed 2010, 218 patients randomized First data presented at ASH Publication expected 2012 start end 2009 Dr Marco Montillo, Hospital Milano. marco.montillo@ospedale niguarda.it Dr Aaron Polliack apol@cc.huji.ac.il Dr Michal Haran Michal.haran@gmail.com Dr Abraham Klepfish klepfish@zahav.net.il Dr Geisler, Dr van Oers <m.h.vanoers@amc.uva.nl > Dr van Oers <m.h.vanoers@amc.uva.nl >, Dr Geisler Initially designed as Protocol for the REL (Rete Ematologica Lombarda) now extended to others centers outside Lumbardy Region in Italy low dose Fludara 12.5mg/m2 D1-3 Cytoxan 150mg/m2 D1-3 Efficacy and dose range of antibody. Analysis of Complement activating pathway July 2011 December 2009

6 HOVON HOVON 88: R-DHAP folowed by RIST allosct in fludarabin refractory CLL; a Phase II study ongoing Dr Van Gelder <m.van.gelder@mumc.nl> December 2009 Spain Hospital Vall d Hebron, Barcelona United Kingdom Lenalidomide + Dexamethasone, phase II NCRI CLL201; Randomised Phase II in relapsed CLL; FCM vs FCM-R (n=52) NCRI CLL202 (CamFlud); Non-randomised Phase II in refractory CLL; SC Campath+fludarabine (n=50) NCRI CLL203 (RESPECT); Newly diagnosed Poor risk Stage A CLL; Lenalidomide therapy for biologically poor risk (n=40) NCRI CLEAR Study; CLL Empirical Antibiotic Regimen: A Phase II trial of broad spectrum antibiotic therapy for early stage, non-progressive chronic lymphocytic leukaemia without adverse prognostic factors. (n=71) NCRI CLL206 (CamPred); Non-randomised Phase II in p53 deleted CLL; Finished, presented at international meetings and published Finished, presented at international meetings but not yet published Closed early due to perception of toxicity from other lenalidomide trials and subsequent poor recruitment Opened July /71 patients recruited (1 st ) Finished, presented at international meetings and published JCO 2012 Dr Francesc Bosch December 2009 Dr Peter Hillmen; Dr Peter Hillmen; Dr Adrian Bloor Prof Steve Devereux Prof Andy Pettitt

7 Campath+HDMP (n=40) NCRI CLL207; Non-randomised Phase II of consolidation with alemtuzumab after chemotherapy; Alemtuzumab SC (n=54) Completed Presented at international meetings. Manuscript in preparation. NCRI CLL208; Non-randomised Phase II untreated patients with CLL considered unfit for fludarabine combinations; Chlorambucil+rituximab (n=100) ADMIRE Study; Randomised Phase II in previously untreated patients with CLL fit for fludarabine-combinations; FCR vs FCM-R (n=218) ARCTIC Study; Randomised Phase II in previously untreated patients with CLL fit for fludarabine-combinations; FCR vs FCM-miniR (n=206) NCRI CLL7 (Complement- 1); Phase III in previously untreated patients with CLL unfit for fludarabinecombinations; Chlorambucil vs Chlorambucil+ofafumuma b (n=444) Completed. Presented at international meetings. Manuscript in preparation. Closed to recruitment March Awaiting analysis of results. Open to recruitment Due to close to recruitment Dec No results yet available Closed to recruitment May Awaiting results. Roche sponsored study International trial; Sponsored by GSK

8 NCRI CLL8 (CLARET); Randomised Phase III of consolidation with alemtuzumab in CLL; Alemtuzumab SC vs no therapy (n=116) Planned to open August 2012 NCRI CLL9 (RIAltO); A Randomised Investigation of Alternative Ofatumumabcontaining regimens in less fit patients with CLL (n=670) NCRI CLL210 (CamDexRev); Phase II trial of alemtuzumab, dexamethasone and lenalidomide followed by randomisation to lenalidomide maintenance versus no further treatment for high-risk CLL (n=85) NCRI CLL211 (CHOP-OR); Single arm NCRI feasibility study of CHOP in combination with ofatumumab, in induction and maintenance for patients with newly diagnosed Richter s Syndrome (n=35) NCRI CLL212 (COSMIC); Combination Fludarabine Open to recruitment December Opened to recruitment February 2012 Opened to recruitment April 2011 Opening to recruitment June 2012 Prof Andrew Pettitt Prof Andrew Pettitt Dr Anna Schuh Prof Peter Hillmen

9 and Cyclophosphamide plus Ofatumumab at Standard or Mega dose In CLL (n=82) NCRI PICCLe Study; Phase I/II clinical trial to assess the efficacy and safety of olaparib, a PARPinhibitor, in relapsed and refractory Chronic Lymphocytic Leukaemia patients with an 11q deletion or ATM mutation and relapsed/refractory patients with T- Prolymphocytic Leukaemia and Mantle Cell Lymphoma (n=76) Opened to recruitment February 2011 Dr Guy Pratt