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Microsoft powerpoint - pix203 ash final poster nov 28.ppt

CHOP-R (cyclophosphamide, doxorubicin, vincristine, prednisone, rituximab) Compared to CPOP-R (cyclophosphamide, pixantrone, vincristine,
prednisone, rituximab) in 1st Line Therapy of Diffuse Large B Cell Lymphoma (DLBCL): An Interim Analysis
R Herbrecht,1 S Couban,2 A Engert,3 F Weissinger,4 M Wilhelm,5 I Gorbatchevsky,6 and R H Van der Jagt,7 1Hôpitaux Universitaires de Strasbourg, Strasbourg, France; 2Queen Elizabeth Health Sciences Centre, Halifax, Nova Scotia, Canada; 3Klinikum der Universität zu Köln, Koln, Germany; 4Klinikum der Universität Würzburg, Würzburg, Germany; 5Klinikum Nürnberg Nord, Nurnberg, Germany; 6Cell Therapeutics, Inc., Seattle, WA, US; and 7Ottawa Hospital, Ottawa, Ontario, Canada.
Select Adverse Events
INTRODUCTION
PATIENT CHARACTERISTICS
SAFETY (preliminary)
• The CHOP-R regimen is the standard regimen for 1st line therapy Experimental
Comparator
• In general, overall adverse events appear balanced between treatment • Pixantrone (BBR 2778) is a novel aza-anthracenedione with • No patients in either treatment arm had an adverse event of heart failure structural similarities to mitoxantrone and with substantially less delayed cardiotoxicity than doxorubicin or mitoxantrone in animal • There were 3 deaths within 30 days of the last dose of study drug on CPOP-R arm. Two of the events were attributed to study treatment • In a phase 1/2 study of CPOP in 65 patients with relapsed NHL (pneumonia concurrent with neutropenia and non-cardiogenic pulmonary who had received a 1st line therapy regimen, patients received edema concurrent with non-neutropenic infection). No deaths within 30 pixantrone at 80 – 180 mg/m2. This study indicated substantial days of the last dose of study drug were reported in the CHOP-R arm.
activity with an overall response rate of 77% and complete • Overall rates of infection were similar in the CPOP-R and CHOP-R arms response (CR) rate of 54% with acceptable toxicity.1 • Studies in indolent NHL demonstrated that the combination of • Transient blue or gray discoloration of skin and blue or green discoloration pixantrone with rituximab is well tolerated and more active than of urine is a known side effect of pixantrone. Adverse events of skin discoloration have been reported in 8% of patients and chromaturia in 5% • The purpose of this phase 1/2 study is to compare CPOP-R to CHOP-R with special regards to safety, activity, and cardiac toxicity • No instances of serious or significant hepatic or renal damage related to and to demonstrate that the response rate is not lower than study therapy have been reported in either treatment arm.
TREATMENT RESPONSES
TREATMENT RESPONSES
• Efficacy results reported here are from the first 40 patients enrolled. Overall Response Rate (CR+PR) at the cycle 4 assessment was
Safety data include preliminary data from 78 patients.
Summary of Adverse Events
similar between treatment arms.*
Experimental Comparator
Experimental
Comparator
STUDY DESIGN
ELIGIBILITY
ELIGIBILITY
• Patients will be treated for 4 cycles. Continued treatment is Inclusion Criteria
determined by patient response3 at the end of cycle 4, as follows: • Histologically confirmed diffuse large B-cell lymphoma according to REAL/WHO Patients with treatment-related adverse events •Patients who demonstrate PR will receive 4 additional cycles of Patients with grade 3 or 4 adverse events • DRUG A
Adequate card DM
iac f INISTRA
unction: LVEF TION
Patients with grade 3 or 4 treatment-related adverse •Patients who experience CR will receive 2 additional cycles of SUMMARY and CONCLUSIONS
•Patients who have no response will be discontinued from the Patients with adverse events leading to withdrawal -absolute neutrophil count (ANC) ≥ 1.5 x 109/L *1 patient discontinued due to febrile neutropenia, 1 due to neutropenia, 1 due to neutropenia and • Based on this preliminary analysis, we conclude that for 1st line therapy of patients with DLBCL, CPOP-R has similar activity to CHOP-R with no more • Responses evaluated using Cheson criteria Cardiac Safety
• Objective response assessed in cycle 4 • Cardiac safety, based on reporting of adverse events and LVEF assessment, Exclusion Criteria
• Asymptomatic absolute LVEF declines of ≥ 10% have been reported with • The mean decrease in LVEF was similar in both treatment arms (14% in TREATMENT
experimental vs. 17% in comparator).
References
1. Borchmann, P., Herbrecht, R., Wilhelm, M. Morschhauser, F. Hess, G. Kutz, K. Stromatt, S. and Engert, A. Results of a Phase II Study of • Major thoracic and/or abdominal surgery in the preceding 4 weeks from which the Experimental Arm
Control Arm
Pixantrone in Combination with Cyclophosphamide, Vincristine, and Prednisone in Patients with Relapsed Aggressive Non-Hodgkin s Lymphoma. Summary of Decreases in LVEF
Blood (Meeting Abstracts) 2006 108 (11):161a • Clinically significant cardiovascular abnormalities 2. Santoro, A., Voglova, J., Gabrail, N., Ciuleanu, T., Liberati, M., Hancock, B.W., Stromatt, S.,and Caballero, D. Comparative trial of BBR 2778 Declines in LVEF
(pixantrone) + rituximab vs single agent rituximab in the treatment of relapsed/refractory indolent non-Hodgkin’s lymphoma (NHL). J Clin Oncol • CTC grade 3-4 uncontrolled intercurrent infection • History of, or clinical symptoms suggestive of HIV, HBV, or HCV 3. Cheson B.D., Horning S.J., Coiffier B., Shipp M.A., Fisher R.I., Connors J.M., Lister T.A., Vose J., Grillo-Lopez A., Hagenbeek A., Cabanil as .F, • Neurological contraindication to vincristine (e.g. peripheral neuropathy) Klippensten D., Hiddemann W., Castellino R., Harris N.L., Armitage J.O., Carter W., Hoppe R., Canellos G.P. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol 1999; 17(4):1244.
Disclosure statement
In compliance with ACCME policy, ASH requires the following disclosures for Dr. Herbrecht: Research Support: Cell Therapeutics, Inc.; Employee: No; Consultant: No; Major stockholder: No; Speakers’ Bureau: No; Scientific Advisory Board: No. All authors received research funds from the sponsor for conducting the clinical trial reported in this abstract. Presentation does not include discussion of off-label use of a drug or medical device: drug is not yet approved.

Source: http://www.celltherapeutics.com/pdf/ASH07_PIX203.pdf

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