ASH News Daily 2012 - Saturday, December 8, 2012 - (Page B-19)

Janssen BTK Inhibitor Trials OLL NOW ENR Recruiting Patients with Relapsed or Refractory MCL (Protocol PCI-32765MCL2001) “SPARK” A Phase 2, Multicenter, Single-Arm Study to Evaluate the Efficacy and Safety of the Single-Agent Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Patients with Mantle Cell Lymphoma Who Progress After Bortezomib Therapy STUDY DESIGN For more information speak to a Research representative at the Janssen booth ING Mantle Cell Lymphoma (MCL) Patients Single arm trial: Ibrutinib PRIMARY OBJECTIVE • Overall response rate (CR + PR) KEY ELIGIBILITY CRITERIA • At least one prior rituximab-containing chemotherapy regimen • At least 2 cycles of bortezomib (single-agent or in combination) • Documented PD during or after bortezomib therapy If you want additional information on this trial: visit www.myclinical-trial.com/MCL-SPARK or visit www.clinicaltrials.gov (NCT01599949) or please contact: William Deraedt, at Janssen R&D, at wderaedt@its.jnj.com STUDY DESIGN Recruiting Patients with Relapsed or Refractory MCL (Protocol PCI-32765MCL3001) “RAY” A Randomized, Controlled, Open-Label, Phase 3 Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, vs. Temsirolimus in Patients with Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy Randomized, two-arm trial: Ibrutinib vs. Temsirolimus PRIMARY OBJECTIVE • Progression free survival KEY ELIGIBILITY CRITERIA • At least one prior rituximab-containing chemotherapy regimen • Documented relapse or PD following the last anti-MCL treatment • No prior treatment with temsirolimus, other mTOR inhibitors, ibrutinib, or other BTK inhibitors. If you want additional information on this trial: visit www.myclinical-trial.com/MCL-RAY or visit www.clinicaltrials.gov (NCT01646021) or please contact: Dr Aleksandra Rizo at Janssen R&D at arizo@its.jnj.com O NOW ENR LLING Chronic Lymphocytic Leukemia (CLL) or STUDY DESIGN Small Lymphocytic Lymphoma (SLL) Patients Recruiting Patients with Relapsed or Refractory CLL/SLL Randomized, two-arm trial: 6 cycles (28d): Background therapy BR + Ibrutinib vs. Background therapy BR + Placebo Thereafter: Ibrutinib and placebo continued until PD or unacceptable toxicity (Protocol PCI-32765CLL3001) “HELIOS” A Randomized, Double-blind, Placebo-Controlled Phase 3 Study of Ibrutinib, a Bruton’s Tyrosine Kinase (BTK) Inhibitor, in Combination with Bendamustine and Rituximab (BR) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma PRIMARY OBJECTIVE • Progression free survival KEY ELIGIBILITY CRITERIA • Active disease (at least one of the IWCLL 2008 criteria for requiring treatment) • At least one prior therapy for CLL/SLL • No presence of deletion of the short arm of chromosome 17, i.e., del (17p13.1) If you want additional information on this trial: visit www.myclinical-trial.com/CLL-HELIOS or visit www.clinicaltrials.gov (NCT01611090) or please contact: Dr. Michelle Mahler at MMahler@its.jnj.com or Dr. Angela Howes at Ahowes@its.jnj.com In 2013 Starting to Recruit Patients With... Refractory FL — Starts March 2013 (Protocol PCI-32765FLR2002) An Open-label, Multicenter, Single-arm, Phase 2 Study of Ibrutinib (PCI-32765) in Subjects with refractory Follicular Lymphoma PRIMARY OBJECTIVE • Overall response rate Newly Diagnosed MCL — Starts April 2013 (Protocol PCI-32765MCL3002) A Randomized, Double-blind, Placebo-Controlled Phase 3 Study of the Bruton’s Tyrosine Kinase (BTK)Inhibitor, PCI-32765 (Ibrutinib), in Combination with Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma PRIMARY OBJECTIVE • Progression free survival KEY ELIGIBILITY CRITERIA KEY ELIGIBILITY CRITERIA • Histologic proof of Grade 1, 2, or 3a FL without clinical evidence of transformation • Must have had at least two prior lines of therapy including at least one rituximab combination chemotherapy regimen • Resistant disease to the last therapy, defined as progression of disease during or within 12 months of the last dose of a CD20 antibody combination chemotherapy regimen If you want additional information on this trial please contact: Dr. Tahamtan Ahmadi at Janssen R&D at tahmadi@its.jnj.com • Diagnosis of MCL • Subject is not a candidate for high-dose chemotherapy (eg, high-dose Ara-C) or SCT because of: a. age: subject is 65 years or older, or b. in subjects less than 65 years old - presence of important comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy or SCT. If you want additional information on this trial please contact: Dr. Aleksandra Rizo at Janssen R&D at arizo@its.jnj.com Janssen Research & Development, LLC 

Table of Contents for the Digital Edition of ASH News Daily 2012 - Saturday, December 8, 2012

ASH News Daily 2012 - Saturday, December 8, 2012

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