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

Completed · Phase 3

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

In brief

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.

Key facts

Study ID

NCT01321541

Run by

CTI BioPharma

People needed

312

Starts

2011-04-20

Expected to finish

2018-09-14

Last updated by the study team

2021-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• 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
• 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
• Crossroads Cancer Center — Effingham, Illinois, United States
• Carle Foundation Physician Services — Mattoon, Illinois, United States
• Carle Cancer Center — Urbana, Illinois, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Baptist Hospital East — Louisville, Kentucky, United States
• Harry and Jeanette Weinberg Cancer Institute at Franklin Square — Baltimore, Maryland, United States
• Center for Cancer and Blood Disorders, PC — Bethesda, Maryland, United States
• Cancer & Hematology Center of Western Michigan — Grand Rapids, Michigan, United States
• Metro Minnesota CCOP-Unity Hospital — Fridley, Minnesota, United States
• Metro Minnesota CCOP-St. Johns — Maplewood, Minnesota, United States
• Metro Minnesota Community Clinical Oncology Program — Saint Louis Park, Minnesota, United States
• Arizona Clinical Research Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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