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

Diffuse Large B-Cell Lymphoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01040871
• Other study ID #: 26866138-LYM-2034
• Status: Completed
• Phase: Phase 2
• First received: December 29, 2009
• Last updated: December 11, 2013
• Start date: January 2010
• Est. completion date: August 2012

Study information

• Verified date: December 2013
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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)

Other known NCT identifiers

• NCT01826084

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• VELCADE
VELCADE intravenous on Days 1, 4, 8, and 11 of a 21 day (3 week) cycle for 6 cycles.
• Rituximab
Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
• Cyclophosphamide
Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
• Doxorubicin
Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
• Prednisone
Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
• Vincristine
Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Gent - UZ GENT, Hematologie, 9K12IE 9de verdiep- polikliniek Hematologie	Gent

Sponsors (2)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response (CR) Rate	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.	6 cycles	No
Secondary	Overall Response Rate	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.	6 cycles	No
Secondary	Rate of Durable Response	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.	Median follow up approx. 12 months	No
Secondary	Rate of Durable Complete Response	Proportion of subjects who achieved a CR with duration of at least 6 months	Median follow up approx 12 months	No
Secondary	Subsequent Anti-lymphoma Therapy Rate at 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.	1 year	No
Secondary	Progression-free Survival (PFS)Rate at 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.	1 year	No
Secondary	Overall Survival Rate at 1-year	Kaplan-meier estimate of overall survival at 1-year measured from date of randomization.	1 year	No
Secondary	Change in Fatigue and Patient Utility Scores		18-24 months	No

External Links

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