The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), or follicular grade 3 lymphoma.
Eligible patients will be randomized to treatment with pixantrone plus rituximab or gemcitabine plus rituximab in up to six 28-day cycles. At the time patients experience progressive disease during study treatment, early follow- up, or intermediate follow-up, they enter the survival follow up period. Patients who complete study treatment or discontinue study treatment for any other reason will participate in the follow-up periods. Early Follow-Up: After treatment completion or discontinuation, patient will enter a 24-week follow-up period. Intermediate Follow-Up: After completing the 24-week early follow-up period, patient will enter an additional 72-week follow-up period. Survival Follow-Up: All patients will be monitored for survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
312
Pixantrone + Rituximab: Rituximab 375 mg/m2 IV on day 1 and pixantrone 50 mg/m2 (equivalent to 85mg/m2 pixantrone dimaleate)IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.
Gemcitabine + Rituximab: Rituximab 375 mg/m2 IV on day 1 and gemcitabine 1000 mg/m2 IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.
Arizona Clinical Research Center
Tucson, Arizona, United States
Arizona Oncology Associates
Tucson, Arizona, United States
Highlands Oncology Group
Bentonville, Arkansas, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, United States
Progression Free Survival (PFS)
PFS is defined as the time of randomization to the date of disease progression or death due to any cause (whichever occurs first)
Time frame: From the date of randomization to the date of progressive disease or death due to any cause (whichever is first reported) (Up to 100 weeks)
Overall Survival
Overall survival is from randomization to death due to any cause
Time frame: From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)
Complete Response Rate
CRR is defined as the proportion of patients who achieve a Complete Response (CR) without additional therapy. CR is defined as the disappearance of all target lesions.
Time frame: From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)
Overall Response Rate
ORR is defined as the proportion of patients who achieve a CR or PR without additional therapy.
Time frame: From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)
Number of Treatment Emergent Adverse Events (TEAE) Related to Study Drug
The number of Participants with Treatment Emergent Adverse Events (TEAE) related to study drug (pixantrone or gemcitabine)
Time frame: From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)
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Rocky Mountain Cancer Centers
Boulder, Colorado, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
George Washington University Department of Medicine
Washington D.C., District of Columbia, United States
Integrated Community Oncology Network-St. Vincent's
Jacksonville, Florida, United States
Integrated Community Oncology Network-Southside
Jacksonville, Florida, United States
...and 121 more locations