Bortezomib and Rituximab in Treating Patients With Mantle Cell Lymphoma Who Have Previously Undergone Stem Cell Transplantation
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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. Giving bortezomib together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib and rituximab together works in treating patients with mantle cell lymphoma who have previously undergone stem cell transplantation
Contiguous Stage II Mantle Cell Lymphoma
Noncontiguous Stage II Mantle Cell Lymphoma
Recurrent Mantle Cell Lymphoma
Stage I Mantle Cell Lymphoma
Stage III Mantle Cell Lymphoma
Stage IV Mantle Cell Lymphoma
Other: laboratory biomarker analysis
Other: immunohistochemistry staining method
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: DNA analysis
Other: pharmacological study
Other: pharmacogenomic studies
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Weekly Maintenance Bortezomib and Rituximab in Mantle Cell Lymphoma Post Autologous Hematopoietic Cell Transplantation|
- Disease-free survival rate [ Time Frame: At 3 years ] [ Designated as safety issue: No ]Assessed by Kaplan-Meier survival analysis. 95% confidence intervals will be calculated using Greenwood's formula.
- Overall survival [ Time Frame: Every 6 months for 3 years ] [ Designated as safety issue: No ]Assessed by Kaplan-Meier survival analysis. 95% confidence intervals will be calculated using Greenwood's formula.
- Time to treatment failure [ Time Frame: Every 6 months for 3 years ] [ Designated as safety issue: No ]Assessed by Kaplan-Meier survival analysis. 95% confidence intervals will be calculated using Greenwood's formula.
- Toxicities of bortezomib and rituximab treatment, graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]Observed toxicities will be summarized in terms of type (e.g. organ affected or ANC), severity (by NCI CTCAE and nadir or maximum values for laboratory measures), date of onset, duration, reversibility, and attribution. Tables will be created to summarize these toxicities and side effects.
|Study Start Date:||August 2011|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (bortezomib and rituximab)
Patients receive bortezomib SC or IV over 3-5 seconds and rituximab IV on days 1, 8, 15, and 22. Treatment with bortezomib repeats every 3 months for up to 8 courses and treatment with rituximab repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Given SC or IV
Other Names:Biological: rituximab
Other Names:Other: laboratory biomarker analysis
Correlative studiesOther: immunohistochemistry staining method
Other Name: immunohistochemistryGenetic: RNA analysis
Correlative studiesGenetic: gene expression analysis
Correlative studiesGenetic: DNA analysis
Correlative studiesOther: pharmacological study
Other Name: pharmacological studiesOther: pharmacogenomic studies
Other Name: Pharmacogenomic Study
I. To evaluate the two year disease free survival in mantle cell lymphoma (MCL) patients treated with bortezomib + rituximab after hematopoietic stem cell transplantation (HSCT).
I. To evaluate the toxicity profile, safety, overall survival, time to treatment failure, remission duration, and biological markers of mantle cell lymphoma patients treated with bortezomib + rituximab after autologous hematopoietic stem cell transplantation.
OUTLINE: Patients receive bortezomib subcutaneously (SC) or intravenously (IV) over 3-5 seconds and rituximab IV on days 1, 8, 15, and 22. Treatment with bortezomib repeats every 3 months for up to 8 courses and treatment with rituximab repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267812
|United States, California|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Robert W. Chen, MD 800-826-4673 email@example.com|
|Principal Investigator: Robert W. Chen, MD|
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Leona A. Holmberg, MD 206-667-4832|
|Principal Investigator: Leona A. Holmber, MD|
|Principal Investigator:||Robert Chen||City of Hope Medical Center|