Bortezomib, Combination Chemotherapy, and Rituximab as First-Line Therapy in Treating Patients With Stage III or Stage IV Follicular Non-Hodgkin's Lymphoma

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv27
  2. Start date: Dec 2006 to May 1, 2007
    • Study completion date: Jan 2012 to Jan 6, 2012
    v26
  3. Primary completion date: Jan 2012 to Apr 2011v25
  4. Trial status: Active, Not Recruiting to Completed
    • Primary and study completion dates changed from estimate of Dec 2011 to Jan 2012
    v24
  5. Study sites: 18 to 19v23
Show 21 earlier versionsHide 21 earlier versions
  1. Primary completion date: Dec 2009 to Dec 2011v22 Show 6 more changesShow less
    • Enrollment target: estimated 90 to confirmed 95
    • Study sites: 19 to 18
    • Study completion date: Dec 2011
    • Secondary endpoints: details revised at 6 of 6 entries
    • Publications: 1 to 2
    • Study arms: 0 to 1
  2. Re-verified, no change to tracked fieldsv21
  3. Lead sponsor: Canadian Cancer Trials Group to NCIC Clinical Trials Groupv20
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 19 of 19 sites
    v19
  5. Site contacts updated at 1 of 19 sitesv18
  6. Interventions: bortezomib (Drug), cyclophosphamide (Drug), prednisone (Drug), rituximab (Drug), vincristine sulfate (Drug) to bortezomib (Drug), cyclophosphamide (Drug), prednisone (Drug), rituximab (Biological), vincristine sulfate (Drug)v17
  7. Study Status, Referencesv16
  8. Interventions: bortezomib (Drug), cyclophosphamide (Drug), prednisone (Drug), rituximab (Drug), vincristine (Drug) to bortezomib (Drug), cyclophosphamide (Drug), prednisone (Drug), rituximab (Drug), vincristine sulfate (Drug)v15
  9. Re-verified, no change to tracked fieldsv14
  10. Study sites: 20 to 19v13
  11. Interventions: bortezomib (Drug), chemosensitization/potentiation therapy (Procedure), chemotherapy (Procedure), cyclophosphamide (Drug), enzyme inhibitor… to bortezomib (Drug), cyclophosphamide (Drug), prednisone (Drug), rituximab (Drug), vincristine (Drug)v12
  12. Study sites: 18 to 20v11
  13. Primary completion date: Dec 2009v10
  14. Study sites: 6 to 18v9
  15. Re-verified, no change to tracked fieldsv8
  16. Interventions: bortezomib (Drug), chemosensitization/potentiation (Procedure), chemotherapy (Procedure), cyclophosphamide (Drug), enzyme inhibitor therapy… to bortezomib (Drug), chemosensitization/potentiation therapy (Procedure), chemotherapy (Procedure), cyclophosphamide (Drug), enzyme inhibitor…v7
  17. Interventions: antibody therapy (Procedure), biological therapy (Procedure), bortezomib (Drug), chemosensitization/potentiation (Procedure), chemotherapy… to bortezomib (Drug), chemosensitization/potentiation (Procedure), chemotherapy (Procedure), cyclophosphamide (Drug), enzyme inhibitor therapy…v6
  18. Site contacts updated at 1 of 6 sitesv5
  19. Study sites: 2 to 6v4
  20. Study sites: 1 to 2v3
  21. Primary endpoints revised (2)v2 Show 4 more changesShow less
    • Secondary endpoints revised (6)
    • Eligibility criteria shortened, about 5 words
    • Study description expanded, about 5 words
    • Study title shortened, about 3 words
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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. Giving bortezomib together with combination chemotherapy and rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib together with combination chemotherapy and rituximab works when given as first-line therapy in treating patients with stage III or stage IV follicular non-Hodgkin's lymphoma.
Trial Details
NCT Number NCT00428142
Lead Sponsor NCIC Clinical Trials Group
Conditions
(from sponsor)		 Lymphoma
Related terms Lymphoma, Lymphoma, Follicular
Enrollment 95 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov