Comparison of Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma or Follicular Grade 3 Lymphoma Who Have Relapsed After Therapy and Are Not Eligible for Stem Cell Transplant

Phase 3

Completed

Conditions: Diffuse Large B-cell Lymphoma
de Novo DLBCL
DLBCL Transformed From Indolent Lymphoma
Follicular Grade 3 Lymphoma

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Diagnosis of DLBCL (de novo DLBCL, or transformed from indolent lymphoma) or follicular grade 3 lymphoma on the basis of tissue biopsy.
Patients with de novo DLBCL must have received 1-3 treatment regimens for DLBCL. Patients with follicular grade 3 lymphoma must have received 1-3 treatment regimens for follicular lymphoma (any grade). Patients with DLBCL transformed from indolent lymphoma must have received at least 1-4 treatment regimens for NHL.
Received rituximab containing a multi-agent therapy for the treatment of NHL.
Not eligible for high-dose chemotherapy and stem cell transplant.
Patients with DLBCL transformed from indolent lymphoma must have had a complete or partial response to a therapy for NHL lasting at least 12 weeks.

Exclusion Criteria

Primary refractory de novo DLBCL or primary refractory follicular grade 3 lymphoma, defined as documented progression within 12 weeks of the last cycle of the first-line multi-agent regimen.
Prior treatment with cumulative dose of doxorubicin or equivalent exceeding 450 mg/m2
Any experimental therapy ≤ 28 days prior to randomization
Other malignancy within last 5 years except for the following: curatively treated basal cell/squamous cell skin cancer, carcinoma in situ of the cervix, superficial transitional cell bladder carcinoma, or in situ ductal carcinoma of the breast after complete resection
Any contraindication or known allergy or hypersensitivity to any study drugs
Concomitant therapy with any anticancer agents, immunosuppressive agents, other investigational anticancer therapies. Low-dose corticosteroids for the treatment of non cancer-related illnesses are permitted.

Arm && Interventions

Group	Intervention	Description
Gemcitabine + Rituximab	Gemcitabine + Rituximab	Gemcitabine and Rituximab
Pixantrone + Rituximab	Pixantrone + Rituximab	Pixantrone and Rituximab

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	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)	PFS is defined as the time of randomization to the date of disease progression or death due to any cause (whichever occurs first)

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)	ORR is defined as the proportion of patients who achieve a CR or PR without additional therapy.
Overall Survival	From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)	Overall survival is from randomization to death due to any cause
Number of Treatment Emergent Adverse Events (TEAE) Related to Study Drug	From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)	The number of Participants with Treatment Emergent Adverse Events (TEAE) related to study drug (pixantrone or gemcitabine)
Complete Response Rate	From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)	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.

Locations (119): Arizona Clinical Research Center
🇺🇸
Tucson, Arizona, United States
Arizona Oncology Associates
🇺🇸
Tucson, Arizona, United States
Highlands Oncology Group
🇺🇸
Fayetteville, Arkansas, United States
Rocky Mountain Cancer Centers
🇺🇸
Denver, Colorado, United States
George Washington University Department of Medicine
🇺🇸
Washington, 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
Integrated Community Oncology Network
🇺🇸
Orange Park, Florida, United States
Carle Physician Group
🇺🇸
Danville, Illinois, United States
Cancer Care Specialists of Central Illinois
🇺🇸
Decatur, Illinois, United States
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Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States