Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma
Tracking Information | |||||
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First Received Date ICMJE | April 7, 2009 | ||||
Last Updated Date | March 9, 2012 | ||||
Start Date ICMJE | March 2009 | ||||
Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Progression-free survival [ Time Frame: 8 years ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Progression-free survival [ Designated as safety issue: No ] | ||||
Change History | Complete list of historical versions of study NCT00878254 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma | ||||
Official Title ICMJE | Phase II Study of Rituximab in Combination With Methotrexate, Doxorubicin, Cyclophosphamide, Leucovorin, Vincritine, Ifosfamide, Etoposide, Cytarabine and Mesna (R-MACLO/VAM) in Patients With Previously Untreaded Mantle Cell Lymphoma | ||||
Brief Summary | RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective when given with rituximab in treating mantle cell lymphoma. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with previously untreated mantle cell lymphoma. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE:
Patients who achieve complete remission after completion of course 4 receive rituximab IV once weekly for 4 weeks. Treatment repeats every 6 months for up to 3 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed monthly for 3 months, every 3 months for 2 years, every 6 months for 3-5 years, and then yearly thereafter. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Lymphoma | ||||
Intervention ICMJE |
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Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 22 | ||||
Estimated Completion Date | December 2012 | ||||
Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||
Ages | 18 Years to 64 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00878254 | ||||
Other Study ID Numbers ICMJE | EPROST-20080803, SCCC-2008043 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | University of Miami Sylvester Comprehensive Cancer Center | ||||
Study Sponsor ICMJE | University of Miami Sylvester Comprehensive Cancer Center | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | University of Miami Sylvester Comprehensive Cancer Center | ||||
Verification Date | March 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |