Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma
|ClinicalTrials.gov Identifier: NCT00711828|
Recruitment Status : Active, not recruiting
First Posted : July 9, 2008
Results First Posted : January 27, 2015
Last Update Posted : March 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue Nodal Marginal Zone Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Splenic Marginal Zone Lymphoma Waldenstrom Macroglobulinemia||Drug: Bortezomib Biological: Rituximab Drug: Cyclophosphamide Drug: Dexamethasone Other: Questionnaire Administration Other: Quality-of-Life Assessment||Phase 2|
I. To assess tumor response to R-CyBor-D in patients with relapsed follicular (Gr 1 or 2), mantle cell, marginal zone lymphomas, small lymphocytic lymphoma (SLL)/chronic lymphocytic leukemia (CLL) and lymphoplasmacytic (Waldenstrom's macroglobulinemia) lymphoma.
I. To evaluate overall survival, progression-free survival, duration of response, and time to treatment failure of patients receiving R-CyBor-D.
II. To describe the adverse event profile (using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v 3.0) of R-CyBor-D.
III. To evaluate quality of life for patient reported neurotoxicity using the Gynecologic Oncology Group's Functional Assessment of Cancer Therapy (FACT/GOG) neurotoxicity questionnaire, version 4.0.
Patients receive rituximab intravenously (IV) on day 1and cyclophosphamide orally (PO), bortezomib IV, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-6 months for up to 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Clinical Trial of Rituximab, Cyclophosphamide, Bortezomib (VELCADE), and Dexamethasone (R-CYBOR-D) in Relapsed Low Grade and Mantle Cell Lymphoma|
|Actual Study Start Date :||August 2008|
|Actual Primary Completion Date :||November 2013|
|Estimated Study Completion Date :||December 2018|
Experimental: Treatment (R-CYBOR-D)
Patients receive rituximab IV on day 1and cyclophosphamide PO, bortezomib IV, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Given IVBiological: Rituximab
Other Name: MOAB IDEC-C2B8Drug: Cyclophosphamide
Given PODrug: Dexamethasone
Other Name: DMOther: Questionnaire Administration
Complete a quality of life questionnaire (FACT/GOG neurotoxicity questionnaire, version 4.0)Other: Quality-of-Life Assessment
Complete a quality of life questionnaire (FACT/GOG neurotoxicity questionnaire, version 4.0)
Other Name: Quality of Life Assessment
- Proportion of Responses (Complete Response or Partial Response) [ Time Frame: up to 12 cycles ]A response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on any evaluation (i.e., best response). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A confidence interval for the true success proportion will be calculated according to the properties of the binomial distribution.
- Overall Survival [ Time Frame: Up to 3 years from registration ]Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
- Progression-free Survival [ Time Frame: Up to 3 years from registration ]Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression or death, whichever occurs first. Progression is defines as having any new lesion or increase by 50% of previously involved sites from nadir. The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier.
- Duration of Response [ Time Frame: Up to 3 years from registration ]Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest objective status is first noted to be either a CR or PR to the earliest date progression is documented. MR for Waldenstrom lymphoma will not be included as a response. Median duration of response and the confidence interval for the median duration will be computed.
- Time to Treatment Failure [ Time Frame: Up to 3 years from registration ]Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.
- Adverse Events [ Time Frame: up to 12 cycles (28 days per cycle) of treatment ]Adverse events were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 after each cycle of treatment. The maximum grade for each type of adverse event were recorded for each patient, and frequency tables were reviewed to determine patterns. For this endpoint, the number of patients receiving a Grade 3, Grade 4, or Grade 5 as their highest reported grade regardless of attribution are reported. A full list of adverse events are reported in the Adverse Events section of this report.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00711828
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Craig Reeder||Mayo Clinic|