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Tracking Information | |||||
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First Received Date † | November 2, 2007 | ||||
Last Updated Date | May 2, 2009 | ||||
Start Date † | November 2007 | ||||
Current Primary Outcome Measures † |
Overall response (complete and partial response) rate [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00553644 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Bortezomib and Lenalidomide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma | ||||
Official Title † | A Phase II Trial of Bortezomib (NSC #681239) + Lenalidomide (Revlimid ™, CC-5013) (NSC #703813) for Relapsed/Refractory Mantle Cell Lymphoma | ||||
Brief Summary | RATIONALE: Bortezomib and lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. Bortezomib may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with lenalidomide may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with lenalidomide works in treating patients with relapsed or refractory mantle cell lymphoma. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: Patients receive induction therapy comprising bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib IV on days 1 and 8 and oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label | ||||
Condition † | Lymphoma | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 54 | ||||
Completion Date | |||||
Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00553644 | ||||
Responsible Party | Richard L. Schilsky, Cancer and Leukemia Group B | ||||
Secondary IDs †† | CALGB-50501 | ||||
Study Sponsor † | Cancer and Leukemia Group B | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | May 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |