Rituximab, Bortezomib,Bendamustine , Dexamethasone, Patients With Mantle Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Study type: Interventional
Phase: Phase 2

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. Bortezomib may stop the growth of
      cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood
      flow to the tumor. Drugs used in chemotherapy, such as doxorubicin, dexamethasone, and
      chlorambucil, work in different ways to stop the growth of cancer cells, either by killing
      the cells or by stopping them from dividing. Giving combination chemotherapy together with
      rituximab and bortezomib may kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving rituximab together with bortezomib,
      doxorubicin, dexamethasone, and chlorambucil works as first-line therapy in treating older
      patients with stage II, stage III, or stage IV mantle cell lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate the efficacy of rituximab, bortezomib, doxorubicin hydrochloride,
           dexamethasone, and chlorambucil as first-line therapy in patients with stage II-IV
           mantle cell lymphoma.

      Secondary

        -  Determine the complete response rate in these patients.

        -  Determine the efficacy, in terms of complete and overall response, by F18
           fludeoxyglucose scan.

        -  Determine overall, disease-free, and event-free survival of these patients.

        -  Assess tolerability of this regimen in these patients.

        -  Evaluate the impact of factors, described in previous protocols, on response to therapy
           and survival.

        -  Assess the impact of residual disease in cerebrospinal fluid on survival.

      OUTLINE: This is a multicenter study.

      Patients receive rituximab IV on day 1 (days 1 and 8 of the first course only); bortezomib IV
      on days 1, 4, 8, and 11; doxorubicin hydrochloride IV continuously over 24 hours on days 1-4;
      dexamethasone IV on days 1-4; and oral chlorambucil on days 20-29. Treatment repeats every 5
      weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

      Patients who achieve at least 50% response receive 2 additional courses of therapy.
    

Intervention name(s): rituximab; bortezomib; dexamethasone; Bendamustine
Intervention type(s): Biological; Drug; Drug; Drug
Intervention description(s): Rituximab, 375 mg/m2 Intraveinous; -Velcade®, 1,3 mg/m2 Intraveinous on days 1, 4, 8 and 11; day - Dexamethasone, 40 mg Intraveinous; -Day 1 and day 2 Bendamustine/Levact ®,, 90 mg/m2 Intraveinous
Other intervention name(s): Mabthera ®,; Velcade; Levact ®
Intervention MeSH terms: Dexamethasone; Rituximab; Bortezomib; Bendamustine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: contiguous stage II mantle cell lymphoma; noncontiguous stage II mantle cell lymphoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma