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

NCT00433537 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2014-10-30

Study results available
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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).

Conditions

  • 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

Interventions

DRUG

bortezomib

Given IV

BIOLOGICAL

rituximab

Given IV

DRUG

cyclophosphamide

Given IV

DRUG

doxorubicin hydrochloride

Given IV

DRUG

vincristine

Given IV

DRUG

dexamethasone

Given IV

BIOLOGICAL

filgrastim

Given SC

BIOLOGICAL

pegfilgrastim

Given SC

PROCEDURE

Autologous stem cell transplantation (ASCT)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Brad Kahl · Eastern Cooperative Oncology Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00433537 on ClinicalTrials.gov