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OpenTrials
Completed

NCT Number: NCT01040871

Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

This is a randomized, open-label, active-control, parallel-group, multicenter, multinational Phase 2 Study of the efficacy and safety of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly Diagnosed Non-Germinal Center B-Cell (non-GCB) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL)

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Key information

Conditions

Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitair Ziekenhuis Gent - UZ GENT, Hematologie, 9K12IE 9de verdiep- polikliniek Hematologie

Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients 18 years or older.
  • Newly Diagnosed non-GCB subtype of DLBCL (Stage II, III or IV).
  • At least 1 measurable site of disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study; and have a negative pregnancy test at screening.
  • Male subjects must agree to use a double barrier method of birth control

Exclusion criteria

  • Prior treatment with VELCADE.
  • Prior extended radiotherapy or chemotherapy for lymphoma
  • More than 150 mg/m2 of prior doxorubicin
  • Major surgery within 3 weeks of study.
  • Peripheral neuropathy or neuralgia of Grade 2 or worse.
  • Active CNS lymphoma
  • Diagnosed or treated for a malignancy other than NHL, with some exceptions
  • Pregnant or breast feeding
  • Active systemic infection
  • Documented of suspected human immunodeficiency virus (HIV)/AIDS
  • Uncontrolled or severe cardiovascular disease
  • Known allergies, hypersensitivity or intolerance to study drugs
  • Serious medical condition that could interfere with study
  • Concurrent treatment with another investigational agent

Treatment and study plan

Velcade

Drug

VELCADE intravenous on Days 1, 4, 8, and 11 of a 21 day (3 week) cycle for 6 cycles.

Rituximab

Drug

Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles

Cyclophosphamide

Drug

Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles

Doxorubicin

Drug

Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles

Prednisone

Drug

Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles

Vincristine

Drug

Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles

Primary outcomes

  1. Complete Response (CR) Rate

    Time frame: 6 cycles

    Complete response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.

    • Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
    • PET scan was negative.
    • The spleen and/or liver, if enlarged before therapy on the basis of physical examination or CT scan, was not palpable on physical examination and was considered normal size by imaging studies; all splenic and hepatic nodules related to lymphomas disappeared.
    • If bone marrow was involved before treatment, the infiltrate cleared on repeated bone marrow biopsy.
    • No new sites of disease were detected.

Secondary outcomes

  1. Overall Response Rate

    Time frame: 6 cycles

    Overall response = Complete Response (CR) + Partial Response (PR) Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.

    Complete Response: see primary endpoint Partial Response: At least a 50% decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses.

  2. Rate of Durable Response

    Time frame: Median follow up approx. 12 months

    Proportion of subjects who achieved a CR or PR with duration of at least 6 months. Duration of response (CR or PR) was calculated from the date of initial documentation of a response to the date of first documented evidence of disease progression or death due to disease progression. Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.

  3. Rate of Durable Complete Response

    Time frame: Median follow up approx 12 months

    Proportion of subjects who achieved a CR with duration of at least 6 months

  4. Subsequent Anti-lymphoma Therapy Rate at 1-year

    Time frame: 1 year

    Kaplan-meier estimate of subsequent anti-lymphoma therapy at 1-year. Time to subsequent anti-lymphoma therapy was measured from the date of randomization to the start date of new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti-lymphoma treatment was censored at the date of death or the last date known to be alive.

  5. Progression-free Survival (PFS)Rate at 1-year

    Time frame: 1 year

    Kaplan-meier estimate of progression-free survival at 1-year. Progression-free survival was defined as the interval between the date of randomization and the date of first documented evidence of disease progression or death.

  6. Overall Survival Rate at 1-year

    Time frame: 1 year

    Kaplan-meier estimate of overall survival at 1-year measured from date of randomization.

  7. Change in Fatigue and Patient Utility Scores

    Time frame: 18-24 months

Sponsors and collaborators

Lead sponsor

Millennium Pharmaceuticals, Inc.

Industry

Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Registry information

Official study title

A Randomized, Open-Label, Multicenter Phase 2 Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 30, 2009
Registry last updated
Jan 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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