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Sponsored by: |
National Cancer Research Network |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00513955 |
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with bortezomib may kill more cancer cells. It is not yet known whether combination chemotherapy is more effective with or without bortezomib in treating mantle cell lymphoma.
PURPOSE: This randomized phase II trial is studying combination chemotherapy and bortezomib to see how well they work compared with combination chemotherapy alone in treating patients with relapsed or refractory mantle cell lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Drug: bortezomib Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisolone Drug: vincristine sulfate Procedure: quality-of-life assessment Procedure: questionnaire administration |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Parallel Randomised Phase II Trial of CHOP Chemotherapy With or Without Bortezomib in Relapsed Mantle Cell Lymphoma |
Estimated Enrollment: | 90 |
Study Start Date: | June 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label, parallel group, multicenter study. Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality of life questionnaires at baseline, prior to each treatment course, and then at 30 days after completion of treatment.
After completion of study treatment, patients are followed at 30 days and then every 12 weeks thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of mantle cell lymphoma (MCL)
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Any prior chemotherapy regimen allowed
Exclusion criteria:
United Kingdom, England | |
Birmingham Heartlands Hospital | Recruiting |
Birmingham, England, United Kingdom, B9 5SS | |
Contact: Guy Pratt, MD, MRCP, MRCPath 44-121-424-3698 | |
Derriford Hospital | Recruiting |
Plymouth, England, United Kingdom, PL6 8DH | |
Contact: Simon Rule, MD 44-1752-517-505 | |
Good Hope Hospital | Recruiting |
Birmingham, England, United Kingdom, B75 7RR | |
Contact: Matthew A. Lumley, MD 44-121-378-6206 matthew.lumley@goodhope.nhs.uk | |
Harrogate District Hospital | Recruiting |
Harrogate, England, United Kingdom, HG2 7SX | |
Contact: Claire Hall, MD 44-11-3206-5570 | |
James Paget Hospital | Recruiting |
Norfolk, England, United Kingdom, NR31 6LA | |
Contact: Shalal Sadullah, MD 44-01-493-452-827 shalal.sadullah@jiaget.nhs.uk | |
Leeds General Infirmary | Recruiting |
Leeds, England, United Kingdom, LS1 3EX | |
Contact: Roderick Johnson, MD 44-113-392-3766 | |
Royal Cornwall Hospital | Recruiting |
Truro, Cornwall, England, United Kingdom, TR1 3LJ | |
Contact: Anton Kruger 44-187-225-2506 anton.kruger@rcht.cornwall.nhs.uk | |
Sunderland Royal Hospital | Recruiting |
Sunderland, England, United Kingdom, SR4 7TP | |
Contact: Lucy Pemberton, MD 44-191-565-6256 | |
Torbay Hospital | Recruiting |
Torquay, England, United Kingdom, TQ2 7AA | |
Contact: Deborah Turner 44-180-365-5244 deborah.turner2@nhs.net | |
Whiston Hospital | Recruiting |
Prescot Merseyside, England, United Kingdom, L35 5DR | |
Contact: Gnanam Satchi, MD 44-151-430-1825 | |
United Kingdom, Wales | |
University Hospital of Wales | Recruiting |
Cardiff, Wales, United Kingdom, CF14 4XW | |
Contact: Clare Rowntree, MBCLB, PhD, FRCP, MRCPath 44-29-2074-4228 clare.rowntree@cardiffandvale.wales.nhs.uk |
Study Chair: | Simon Rule, MD | Derriford Hospital |
Study ID Numbers: | CDR0000559820, NCRN-Ply-26s, EU-20747, ISRCTN200600609024 |
Study First Received: | August 8, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00513955 |
Health Authority: | Unspecified |
recurrent mantle cell lymphoma |
Immunoproliferative Disorders Methylprednisolone Lymphoma, Mantle-Cell Bortezomib Vincristine Methylprednisolone acetate Prednisolone acetate Cyclophosphamide Mantle cell lymphoma |
Recurrence Doxorubicin Lymphatic Diseases Prednisolone Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antibiotics, Antineoplastic Hormones Therapeutic Uses Alkylating Agents Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents, Hormonal |
Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Protease Inhibitors Neoplasms Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |