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Selected Clinical Trials in Diffuse Large B-Cell Lymphoma and T-Cell Lymphoma
#LINICAL 4RIALS ,IST Selected Clinical Trials in Diffuse Large B-Cell Lymphoma and T-Cell Lymphoma Status for All Trials, October 2009: Recruiting Trials Open in the United States Official Title: PILLAR-2 trial: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study of RAD001 Adjuvant Therapy in Poor-Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-line Rituximab-chemotherapy) Primary Endpoints: Disease-free survival (DFS); incidence of adverse events; incidence of noninfectious pneumonitis Sponsor: Novartis Pharmaceuticals Study Chair: Novartis Pharmaceuticals Contact Information: Novartis Pharmaceuticals; Ph: 800-340-6843 Clinicaltrials.gov ID: NCT00790036 Study Start: 2009 Official Title: B020603 trial: A Randomized, Double-blind Placebo-controlled Study Comparing the Effect of Avastin in Combination With MabThera Plus CHOP, and MabThera Plus CHOP Alone, on Progression-free Survival in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma Primary Endpoint: Progression-free survival (PFS) Sponsor: Hoffmann-La Roche; Genentech Study Chair: Hoffmann-La Roche Clinical Trials Contact Information: Ph: 888-662-6728; e-mail: [email protected] Clinicaltrials.gov ID: NCT00486759 Study Start: 2007 Official Title: RATE trial: A Phase III Multicenter, Open-Label Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-Cell or Follicular Non-Hodgkin’s Lymphoma Primary Endpoint: Grade 3/4 infusion-related toxicity Sponsor: Genentech Study Chair: Jamie Hirata, PharmD Contact Information: Mark Fisher; e-mail: [email protected] Clinicaltrials.gov ID: NCT00719472 Study Start: 2008 Official Title: CALGB 50303: Phase III Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R With Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas Primary Endpoint: Event-free survival (EFS) Sponsors: Cancer and Leukemia Group B; National Cancer Institute Study Chair: Wyndham H. Wilson, MD, PhD Contact Information: Ph: 301-435-2415; e-mail: [email protected] Clinicaltrials.gov ID: NCT00118209 Study Start: 2005 Official Title: PRELUDE trial: A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin Primary Endpoint: Overall DFS Sponsor: Eli Lilly and Company Study Chair: Not reported Contact Information: Ph: 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov ID: NCT00332202 Study Start: 2006 Official Title: CLBH589132212 study: A Phase II Study of Oral LBH589 in Adult Patients With Cutaneous T-Cell Lymphoma Who Are Intolerant to or Have Progressed on or After Prior HDAC Inhibitor Primary Endpoint: Overall response rate Sponsor: Novartis Study Chair: Novartis Contact Information: Novartis; Ph: 800-340-6843 Clinicaltrials.gov ID: NCT00490776 Study Start: 2007
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$MJOJDBM5SJBMT-JTU Selected Clinical Trials in Diffuse Large B-Cell Lymphoma and T-Cell Lymphoma Status for All Trials, October 2009: Recruiting Selected International Trials of Interest Official Title: DSHNHL 2006-1B/ACT-2: Phase III Study of CHOP-14 Plus or Minus Alemtuzumab in Peripheral T-Cell Lymphoma of the Elderly Primary Endpoint: EFS Sponsors: University of Göttingen; German High-Grade Non-Hodgkin’s Lymphoma Study Group; Nordic Lymphoma Group Study Chair: Lorenz H. Trümper, MD Contact Information: Ph: 49-551-398535, ext. 8535; e-mail: [email protected] Clinicaltrials.gov ID: NCT00725231 Study Start: 2008 Official Title: ACT-1: A Randomized Phase III Study to Evaluate the Efficacy of Chemoimmunotherapy With the Monoclonal Antibody Campath-1H (Alemtuzumab) Given in Combination With 2-weekly CHOP Versus 2-weekly CHOP Alone and Consolidated by Autologous Stem Cell Transplant, in Young Patients With Previously Untreated Systemic Peripheral T-Cell Lymphomas Primary Endpoint: EFS Sponsor: Aarhus University Hospital Study Chair: Francesco d’Amore, MD Contact Information: Ph: 45-8949-7567; e-mail: [email protected] Clinicaltrials.gov ID: NCT00646854 Study Start: 2007 Official Title: MAYO-LS0881: Phase III Study of the Interest of Radiotherapy After 4 or 6 Cycles of CHOP 14 Rituximab Regimen of Chemotherapy, Patients With Aggressive Localized Lymphoma Primary Endpoints: EFS; PFS Sponsor: Groupe Ouest Est d’Etude des Leucémies et Autres Maladies du Sang (GOELAMS) Study Chair: Thierry Lamy, MD, PhD Contact Information: Ph: 33-2-99-28-42-91; e-mail: [email protected] Clinicaltrials.gov ID: NCT00841945 Study Start: 2005 Official Title: UNFOLDER 21/14 Study: Randomized Study Comparing an Immuno-Chemotherapy With 6 Cycles of the Monoclonal Anti-CD20 Antibody Rituximab in Combination With 6 Cycles of Chemotherapy With CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) at 21-Day Intervals or 14-Day Intervals, Both With or Without Consolidating Radiotherapy or Large Tumour Masses (≥ 7.5 cm) and/or Extranodal Involvement in Patients With Aggressive CD20 B-Cell Lymphoma Aged 18 to 60 Years With Age-Adjusted IPI = 1 (All) or IPI = 0 With a Large Tumour Mass (≥ 7.5 cm) Primary Endpoint: Time to Treatment Failure Sponsor: German High-Grade Non-Hodgkin’s Lymphoma Study Group Study Chair: Michael G. M. Pfreundschuh, MD Clinicaltrials.gov ID: NCT00278408 Study Start: 2005
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$MJOJDBM5SJBMT-JTU Selected Clinical Trials in Diffuse Large B-Cell Lymphoma and T-Cell Lymphoma Status for All Trials, October 2009: Recruiting Selected International Trials of Interest Official Title: DSHNHL 2006-1B/ACT-2: Phase III Study of CHOP-14 Plus or Minus Alemtuzumab in Peripheral T-Cell Lymphoma of the Elderly Primary Endpoint: EFS Sponsors: University of Göttingen; German High-Grade Non-Hodgkin’s Lymphoma Study Group; Nordic Lymphoma Group Study Chair: Lorenz H. Trümper, MD Contact Information: Ph: 49-551-398535, ext. 8535; e-mail: [email protected] Clinicaltrials.gov ID: NCT00725231 Study Start: 2008 Official Title: ACT-1: A Randomized Phase III Study to Evaluate the Efficacy of Chemoimmunotherapy With the Monoclonal Antibody Campath-1H (Alemtuzumab) Given in Combination With 2-weekly CHOP Versus 2-weekly CHOP Alone and Consolidated by Autologous Stem Cell Transplant, in Young Patients With Previously Untreated Systemic Peripheral T-Cell Lymphomas Primary Endpoint: EFS Sponsor: Aarhus University Hospital Study Chair: Francesco d’Amore, MD Contact Information: Ph: 45-8949-7567; e-mail: [email protected] Clinicaltrials.gov ID: NCT00646854 Study Start: 2007 Official Title: MAYO-LS0881: Phase III Study of the Interest of Radiotherapy After 4 or 6 Cycles of CHOP 14 Rituximab Regimen of Chemotherapy, Patients With Aggressive Localized Lymphoma Primary Endpoints: EFS; PFS Sponsor: Groupe Ouest Est d’Etude des Leucémies et Autres Maladies du Sang (GOELAMS) Study Chair: Thierry Lamy, MD, PhD Contact Information: Ph: 33-2-99-28-42-91; e-mail: [email protected] Clinicaltrials.gov ID: NCT00841945 Study Start: 2005 Official Title: UNFOLDER 21/14 Study: Randomized Study Comparing an Immuno-Chemotherapy With 6 Cycles of the Monoclonal Anti-CD20 Antibody Rituximab in Combination With 6 Cycles of Chemotherapy With CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) at 21-Day Intervals or 14-Day Intervals, Both With or Without Consolidating Radiotherapy or Large Tumour Masses (≥ 7.5 cm) and/or Extranodal Involvement in Patients With Aggressive CD20 B-Cell Lymphoma Aged 18 to 60 Years With Age-Adjusted IPI = 1 (All) or IPI = 0 With a Large Tumour Mass (≥ 7.5 cm) Primary Endpoint: Time to Treatment Failure Sponsor: German High-Grade Non-Hodgkin’s Lymphoma Study Group Study Chair: Michael G. M. Pfreundschuh, MD Clinicaltrials.gov ID: NCT00278408 Study Start: 2005
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