Bortezomib and Rituximab in Treating Patients With Mantle Cell Lymphoma Who Have Previously Undergone Stem Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT01267812|
Recruitment Status : Active, not recruiting
First Posted : December 29, 2010
Last Update Posted : March 7, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: bortezomib Biological: rituximab Other: laboratory biomarker analysis Other: immunohistochemistry staining method Genetic: RNA analysis Genetic: gene expression analysis Genetic: DNA analysis Other: pharmacological study Other: pharmacogenomic studies Other: Questionnaire Administration||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Weekly Maintenance Bortezomib and Rituximab in Mantle Cell Lymphoma Post Autologous Hematopoietic Cell Transplantation|
|Study Start Date :||August 26, 2011|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
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: laboratory biomarker analysis
Other: immunohistochemistry staining method
Other Name: immunohistochemistry
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: DNA analysis
Other: pharmacological study
Other Name: pharmacological studies
Other: pharmacogenomic studies
Other Name: Pharmacogenomic Study
Other: Questionnaire Administration
Other Name: Ancillary Studies
- Disease-free survival rate [ Time Frame: At 3 years ]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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01267812
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Robert Chen||City of Hope Medical Center|