Phase 2
Completed N=77
Combination Chemotherapy and Rituximab in Treating Patients With Untreated Mantle Cell Lymphoma
Source: ClinicalTrials.gov NCT00433537 ↗Enrolled (actual)
77
Serious AEs
72.1%
Results posted
Oct 2014
Primary outcomePrimary: Complete Response (CR) Rate — 0.68 proportion
Summary
This phase II trial is studying how well giving rituximab together with combination chemotherapy and bortezomib works in treating patients with untreated 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. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or 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.
Treatment consists of six agents: bortezomib (Vc), rituximab (R), cyclophosphamide (C), vincristine (V), doxorubicin (A), and dexamethasone (D) (VcR-CVAD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response (CR) Rate |
0.68 | — |
| SECONDARY 2-year Progression-free Survival (PFS) |
0.79; 0.76 | — |
| SECONDARY 3-year Overall Survival (OS) |
0.91; 0.96 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have a histologically confirmed diagnosis of mantle cell lymphoma by demonstrating appropriate morphology plus at least one of the following on the biopsy specimen: nuclear cyclin D1+ by immunohistochemistry; t(11;14) by fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), or conventional karyotyping
- No prior chemotherapy, immunotherapy or radiotherapy for mantle cell lymphoma; a brief course of steroids ( 1500 mm^3 (unless low count due to marrow involvement or splenomegaly)
- Platelets > 100, 000 mm^3 (unless low counts due to marrow involvement or splenomegaly)
- Creatinine 3 years
- Any adjuvant hormonal therapy must have been discontinued > 3 months prior to registration
- Known central nervous system (CNS) involvement
Data sourced from ClinicalTrials.gov (NCT00433537). 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. Informational only — not medical advice.