Phase 2
N=21
Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma
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
Bottom Line
View on ClinicalTrials.gov: NCT00711828 ↗Enrolled (actual)
21
Serious AEs
33.3%
Results posted
Jan 2015
Primary outcome: Primary: Proportion of Responses (Complete Response or Partial Response) — 19.0; 42.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bortezomib (Drug); Rituximab (Biological); Cyclophosphamide (Drug); Dexamethasone (Drug); Questionnaire Administration (Other); Quality-of-Life Assessment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Responses (Complete Response or Partial Response) |
19.0; 42.9 | — |
| SECONDARY Overall Survival |
54.8 | — |
| SECONDARY Progression-free Survival |
11.6 | — |
| SECONDARY Duration of Response |
25.9 | — |
| SECONDARY Time to Treatment Failure |
6.6 | — |
| SECONDARY Adverse Events |
19; 8; 0 | — |
Summary
This phase II trial is studying how well giving rituximab and cyclophosphamide together with bortezomib and dexamethasone (R-CyBor-D) works in treating patients with relapsed or refractory low-grade follicular lymphoma, Waldenstrom macroglobulinemia, or mantle cell lymphoma. 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. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab and bortezomib together with combination chemotherapy may kill more cancer cells.
Eligibility Criteria
Inclusion Criteria
- Histological confirmation of relapsed or refractory follicular Grades 1 or 2 lymphoma, mantle cell lymphoma (MCL), small lymphocytic lymphoma/chronic lymphocytic leukemia (SLL/CLL), extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT) type, nodal marginal zone B-cell lymphoma, splenic marginal zone B-cell lymphoma, or lymphoplasmacytic lymphoma (Waldenstrom's macroglobulinemia/WM) by biopsy ≤ 6 months prior to registration
- NOTE: MCL diagnosis should be confirmed by cyclin D1 staining or fluorescence in situ hybridization (FISH) (t(11;14))
- Measurable disease by computed tomography (CT), positron emission tomography (PET)/CT or magnetic resonance imaging (MRI) scans with lymph nodes ≥2.0 cm in at least one dimension or tumor cells in the blood ≥ 5 x10^9/L
- NOTE: Lymphoplasmacytic lymphoma (WM) patients without lymphadenopathy must have 1.) >10% lymphocytes, lymphoplasmacytic cells or plasma cells on a bone marrow aspirate/biopsy, and 2.) quantitative IgM ≥ 400mg/dL
- Expected survival > 3 months
- ECOG Performance Status (PS) 0, 1 or 2
- Absolute Neutrophil Count ≥ 1200
- Platelet ≥ 75000
- Hemoglobin ≥ 8.0 g/dL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 x ULN
- Aspartate aminotransferase (AST) ≤ 3 x ULN
- Creatinine ≤ 1.5 x ULN
- Female subject is either postmenopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of VELCADE (bortezomib), or agree to completely abstain from heterosexual intercourse
- Male subjects, even if surgically sterilized (i.e., status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- Willingness to return to Mayo Clinic institution for follow-up
- Negative serum pregnancy test done <7 days prior to registration, for women of childbearing potential only
- Willingness to complete questionnaires by themselves or with assistance
Exclusion Criteria
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- Pregnant women -- confirmation that the subject is not pregnant must be established by a negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women;
- Nursing women;
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse event of the prescribed regimen
- Patients known to be human immunodeficiency virus (HIV) positive
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Diagnosed or treated for another malignancy ≤ 3 years prior to registration, with the exception of complete resection of basal cell carcinoma or s
Data sourced from ClinicalTrials.gov (NCT00711828). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.