Phase 2
N=68
S0601 Rituximab, Combination Chemotherapy, and Bortezomib Followed by Bortezomib Alone in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00376961 ↗Enrolled (actual)
68
Serious AEs
0.9%
Results posted
Feb 2013
Primary outcome: Primary: 2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM) — 62 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rituximab (Biological); bortezomib (Drug); cyclophosphamide (Drug); doxorubicin hydrochloride (Drug); prednisone (Drug); vincristine sulfate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM) |
62 | — |
| SECONDARY Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM). |
17; 16; 13; 1; 4; 14 | — |
| SECONDARY 2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM) |
85 | — |
| SECONDARY Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
1; 0; 1; 0; 1; 0 | — |
Summary
RATIONALE: 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. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and bortezomib may kill more cancer cells. Giving bortezomib as maintenance therapy may keep the cancer from progressing.
PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy and bortezomib followed by bortezomib alone works in treating patients with newly diagnosed mantle cell lymphoma.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed mantle cell lymphoma (MCL) meeting the following criteria:
- Stage III-IV or bulky stage II disease
- Confirmation of positivity for the following phenotypes by immunohistochemistry or flow cytometry:
- Cluster of differentiation antigen 19 (CD19) (or CD20)
- Cyclin D1 OR evidence of t(11;14) translocation by cytogenetic analysis or fluorescent in situ hybridization
- Newly diagnosed, previously untreated disease
- Bidimensionally measurable disease by conventional techniques
- No nonmeasurable disease only
- Adequate tumor tissue from original diagnostic specimen available
- Tissue obtained by needle aspiration or cytology not allowed
- No clinical evidence of central nervous system (CNS) involvement by lymphoma
- Co-registration on protocols SWOG-8947 and SWOG-8819 is strongly encouraged
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No peripheral neuropathy ≥ grade 2
- No hypersensitivity to bortezomib, boron, or mannitol
- No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the patient is currently in complete remission, or any other cancer for which the patient has been disease free for the past 5 years
- HIV negative
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
- More than 14 days since prior investigational drugs
Data sourced from ClinicalTrials.gov (NCT00376961). 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.