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Sponsored by: |
Cell Therapeutics |
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Information provided by: | Cell Therapeutics |
ClinicalTrials.gov Identifier: | NCT00268853 |
The purpose of this study is to compare the standard CHOP-R regimen of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Rituximab to CPOP-R (same regimen, but substituting Doxorubicin with Pixantrone). The objective is to show that CPOP-R is not inferior to CHOP-R and less toxic to the heart.
Condition | Intervention | Phase |
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Diffuse Large-Cell Lymphoma |
Drug: CPOP-R Drug: CHOP-R |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Cyclophosphamide, Doxorubicin, Vincristine, Prednisone Plus Rituximab (CHOP-R) and Cyclophosphamide, Pixantrone, Vincristine, Prednisone Plus Rituximab (CPOP-R) in Patients With Diffuse Large-B-Cell Lymphoma: A Phase II, Randomized, Multicenter, Comparative Trial |
Estimated Enrollment: | 280 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: CPOP-R
Cyclophosphamide 750 mg/m2, pixantrone 150 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
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2: Active Comparator |
Drug: CHOP-R
Cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
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In preclinical studies, pixantrone has shown significantly less cardiotoxicity than other anthracyclines or anthracenediones. In addition, patients with relapsed disease, who have received prior maximum doses of anthracyclines, have tolerated high doses of pixantrone with minimal added cardiotoxicity. Pixantrone is currently being studied in a Phase III study in 3rd line aggressive NHL.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At least one objectively bidimensionally measurable lesion as demonstrated by CT, spiral CT, or MRI that can be followed for response as target lesion. Patients with the following sites of disease are NOT eligible:
Exclusion Criteria:
14. Any condition which, in the judgment of the Investigator, would place the subject at undue risk, interfere with the results of the study, or make the subject otherwise unsuitable. 15. General status that, in the opinion of the Investigator does not permit the administration of eight courses of CHOP-R/CPOP-R. 16. Treatment with any other investigational study drug within 30 days before randomization. Patient must have recovered from all side effects of other investigational therapy. 17. Potentially fertile men and women and their sexual partners not willing to use adequate contraception as defined by the Investigator during the study and for 6 months after the last day of study drug administration.
18. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.
Study Director: | Igor Gorbatchevsky, M.D. | Cell Therapeutics |
Responsible Party: | Cell Therapeutics ( Igor Gorbatchevsky, Medical Director ) |
Study ID Numbers: | PIX203 |
Study First Received: | December 21, 2005 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00268853 |
Health Authority: | United States: Food and Drug Administration |
lymphoma NHL large cell phase II |
CHOP R CPOP R non Hodgkins |
Prednisone Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Rituximab Vincristine Cyclophosphamide Doxorubicin |
Lymphoma, B-Cell Lymphoma, large-cell Lymphatic Diseases B-cell lymphomas Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antimitotic Agents Antibiotics, Antineoplastic |
Hormones Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |