This is a randomized, open-label, multi-center, phase 2 study of RCHOP with or without VELCADE in adult patients with previously untreated non-(Germinal B-Cell-like) GCB Diffuse Large B-cell Lymphoma (DLBCL). The study will determine whether the addition of VELCADE to RCHOP improves progression-free survival (PFS) in patients with non-GCB DLBCL.
The drug tested in this study is called bortezomib (VELCADE®). VELCADE® was tested in people who have Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma. This study looked at the efficacy of RCHOP \[rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone\] with or without VELCADE®. The study enrolled 206 patients. Participants were enrolled in one of the two open label treatment groups: * RCHOP * Vc-RCHOP \[bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone\] Participants received treatment for up to six, 21-day cycles. This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 48 months. Participants made multiple visits to the clinic, and were followed for progression free survival and overall survival until patient withdrawal, death, or 2 years after the last participant was enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
206
Progression-Free Survival (PFS) in Patients With Non-germinal Center B-cell-like (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL)
PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by \> 50% of previously involved sites from nadir.
Time frame: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm
Progression-Free Survival Rate
PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by \> 50% of previously involved sites from nadir. The progression-free survival rate is defined as the Kaplan-Meier (KM) estimate of progression-free survival at 2 years.
Time frame: 2 Years (Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm)
Overall Survival
Overall survival is defined as the time from the date of randomization to the date of death from any cause. A participant who is alive at the end of his/her study follow-up is censored at the date of last contact.
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Doxorubicin IV solution
Vincristine IV
Prednisone tablet
Tower Cancer Research Foundation
Beverly Hills, California, United States
Fountain Valley Regional Hospital
Fountain Valley, California, United States
St. Jude Heritage Healthcare
Fullerton, California, United States
Moores Cancer Center- UCSD
La Jolla, California, United States
Antelope Valley Cancer Center
Lancaster, California, United States
Loma Linda University Cancer Center
Loma Linda, California, United States
University of Southern California
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
TORI- Central Pharmacy
Los Angeles, California, United States
TORI- Central Regulatory
Los Angeles, California, United States
...and 60 more locations
Time frame: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with the best overall response complete response (CR) + partial response (PR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=disappearance of all evidence of disease and PR=regression of measurable disease and no new sites.
Time frame: End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]
Complete Response Rate
Complete Response Rate is defined as the percentage of participants with the best response of Complete Response (CR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease.
Time frame: End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]
Duration of Response
Duration of response is defined as the time (in months) from the date of first documentation of confirmed complete response (CR) or partial response (PR) to the date of first documentation of progressive disease (PD), relapse from CR or death related to disease. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), duration of response is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using IWG-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites and PD= any new lesion or increase by \> 50% of previously involved sites from nadir.
Time frame: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm
Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Negative Rate
FDG-PET negative rate is defined as the percentage of participants FDG-PET negative at the given time-point.
Time frame: End of Cycle 2 and End of Treatment (Cycle 6) [Median of 16 weeks on treatment]
Time to Progression (TTP)
TTP is defined as the time from the date of randomization to the date of first documentation of progressive disease, relapse from CR, or death related to disease under study if participant did not have any documentation of disease progression prior to death caused by lymphoma or complications thereof. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), TTP is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by \> 50% of previously involved sites from nadir.
Time frame: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) by Category
Percentage of participants in the following categories: • At least 1 TEAE • Drug-related, TEAEs • Grade 3 or higher TEAEs. Grade 3 are AEs of Severe Intensity • Grade 3 or higher drug-related, TEAEs • TEAEs resulting in study drug discontinuation • Serious TEAEs An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Time frame: First dose of study drug through 30 days after the last dose of study drug (Up to 26 Weeks)
Percentage of Participants With Chemistry and Hematology Laboratory Values Grade 3 or Higher
Percentage of participants who shifted from a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 0, 1, or 2 at Baseline to a Grade 3 or higher on study (worst post-baseline grade). Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=Life-threatening consequences and 5=Death related to AE.
Time frame: Days 1, 4 and 10 of each cycle and end of treatment visit (Median of 16 weeks on treatment)