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Status:

COMPLETED

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

Lead Sponsor:

NCIC Clinical Trials Group

Conditions:

Lymphoma

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

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, wor...

Detailed Description

OBJECTIVES: Primary * Assess the efficacy of systemic first-line treatment comprising bortezomib, cyclophosphamide, vincristine, prednisone, and rituximab, in terms of complete response rate, in pat...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed follicular non-Hodgkin's lymphoma meeting the following criteria:
  • Stage III or IV disease
  • Grade 1, 2, or 3 disease requiring systemic first-line treatment
  • No transformation to diffuse large cell lymphoma
  • At least 1 bidimensionally measurable lesion meeting 1 of the following criteria:
  • Lymph nodes \> 1.5 cm x 1.0 cm by physical exam or CT scan
  • Other non-nodal lesion ≥ 1.0 cm x 1.0 cm by MRI or CT scan OR ≥ 1.0 cm x 1.0 cm (e.g., skin lesions or nodules) by physical exam
  • Must have a medical indication for treatment, as indicated by 1 of the following:
  • Presence of constitutional symptoms that are attributed to lymphoma (e.g., B symptoms, including night sweats, fever, weight loss, fatigue, or pain)
  • Lymphadenopathy that requires treatment based on presence of associated symptoms, potential threat to organ function (e.g., ureteric compromise from retroperitoneal disease), or degree of enlargement (i.e., \> 5 cm)
  • Impairment of normal organ function (e.g., impaired hematopoiesis due to marrow involvement by lymphoma or from splenomegaly and hypersplenism)
  • Immune-related complications of lymphoma that require therapy
  • Rate of disease progression for which observation is deemed inappropriate
  • No history of any other lymphoproliferative disorder or evidence of transformation to an aggressive histology lymphoma
  • No known CNS involvement by lymphoma
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Platelet count ≥ 75,000/mm\^3\*
  • Absolute neutrophil count ≥ 1,000/mm\^3\*
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • AST or ALT ≤ 2.5 times ULN (5 times ULN if liver involvement with lymphoma)
  • Able (i.e., sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French
  • Inability (illiteracy in English or French, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study
  • No history of other malignancies, except for the following:
  • Adequately treated nonmelanoma skin cancer
  • Curatively treated in situ cancer of the cervix
  • Ductal carcinoma in situ of the breast (as long as radiation limitation is not exceeded)
  • Other solid tumors curatively treated with no evidence of disease for \> 5 years
  • No history of allergic reactions attributed to compounds containing boron or mannitol
  • No history of an unusual or severe allergic reaction to rituximab or similar agent
  • No pre-existing neuropathy ≥ grade 2
  • No known HIV infection
  • No other serious illness or medical condition that would preclude study participation, including any of the following:
  • Active, uncontrolled bacterial, fungal, or viral infection
  • Significant cardiac dysfunction
  • Cardiovascular disease NOTE: \*Exceptions will be allowed for values below these thresholds in patients with marrow involvement by lymphoma or lymphoma-related hypersplenism
  • PRIOR CONCURRENT THERAPY:
  • No prior systemic therapy for lymphoma
  • No prior bortezomib, cyclophosphamide, or vincristine
  • At least 4 weeks since prior radiotherapy that involved ≤ 25% of functioning bone marrow and recovered
  • Exceptions may be made for low-dose, nonmyelosuppressive radiotherapy or if the irradiated field is not a significant marrow-bearing area
  • At least 2 weeks since prior major surgery
  • No other concurrent anticancer therapy, investigational agents, corticosteroids (except for physiologic replacement or antiemesis), cytotoxic chemotherapy, or immunotherapy

Exclusion

    Key Trial Info

    Start Date :

    May 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 6 2012

    Estimated Enrollment :

    95 Patients enrolled

    Trial Details

    Trial ID

    NCT00428142

    Start Date

    May 1 2007

    End Date

    January 6 2012

    Last Update

    August 4 2023

    Active Locations (19)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 5 (19 locations)

    1

    Cross Cancer Institute

    Edmonton, Alberta, Canada, T6G 1Z2

    2

    BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia, Canada, V3V 1Z2

    3

    BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, Canada, V5Z 4E6

    4

    BCCA - Vancouver Island Cancer Centre

    Victoria, British Columbia, Canada, V8R 6V5