Phase 2 N=77 Treatment

Combination Chemotherapy and Rituximab in Treating Patients With Untreated Mantle Cell Lymphoma

Contiguous Stage II Mantle Cell Lymphoma · Noncontiguous Stage II Mantle Cell Lymphoma · Stage I Mantle Cell Lymphoma · Stage III Mantle Cell Lymphoma · Stage IV Mantle Cell Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00433537 ↗

Enrolled (actual)

Serious AEs

72.1%

Results posted

Oct 2014

Primary outcome: Primary: Complete Response (CR) Rate — 0.68 proportion

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: bortezomib (Drug); rituximab (Biological); cyclophosphamide (Drug); doxorubicin hydrochloride (Drug); vincristine (Drug); dexamethasone (Drug); filgrastim (Biological); pegfilgrastim (Biological); Autologous stem cell transplantation (ASCT) (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: Jun 2013

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	—

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).

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

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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.