A Trial in Patients With Diffuse Large-B-cell Lymphoma Comparing Pixantrone Against Doxorubicin
- Conditions
- Diffuse Large-Cell Lymphoma
- Interventions
- Drug: CPOP-RDrug: CHOP-R
- Registration Number
- NCT00268853
- Lead Sponsor
- CTI BioPharma
- Brief Summary
The purpose of this study is to compare the standard CHOP-R regimen of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Rituximab to CPOP-R (same regimen, but substituting Doxorubicin with Pixantrone). The objective is to show that CPOP-R is not inferior to CHOP-R.
- Detailed Description
In preclinical studies, pixantrone has shown significantly less cardiotoxicity than other anthracyclines or anthracenediones. In addition, patients with relapsed disease, who have received prior maximum doses of anthracyclines, have tolerated high doses of pixantrone with minimal added cardiotoxicity. Pixantrone is currently being studied in a Phase III study in 3rd line aggressive NHL.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
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Previously untreated and histologically confirmed diffuse large B-cell lymphoma according to REAL/WHO classification.
-
Stage II, III or IV disease
-
CD20+
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Age ≥ 18 years
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ECOG performance status ≤ 2
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At least one objectively bidimensionally measurable lesion as demonstrated by CT, spiral CT, or MRI that can be followed for response as target lesion. Patients with the following sites of disease are NOT eligible:
- Patients with only skin lesions or only palpable lymph nodes.
- Patients with spleen or bone marrow as only site of disease.
-
Life expectancy ≥ 3 months
-
Serum bilirubin ≤ 1.5 x the institution's upper limit normal (ULN) and creatinine ≤ 2.0 ULN and AST or ALT ≤ 2.0 x the institution's ULN. If hepatic involvement by lymphoma is present, AST or ALT may be ≤ 5.0 x the institution's ULN.
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LVEF ≥ 50% determined by MUGA scan.
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Ability to comply with the visit schedule and assessments required by the protocol.
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Signed approved informed consent, with understanding of study procedures.
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Any prior chemotherapy (except intrathecal chemotherapy at diagnosis and pretreatment corticosteroid therapy) or radiotherapy: Patients may receive corticosteroid pretreatment therapy for up to 7 days after randomization, pending Investigator's decision to reduce tumor burden.
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Histological diagnosis of T-cell lymphoma or any B-cell lymphoma other than diffuse large B-cell.
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History of indolent lymphoma
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Active CNS involvement based on clinical evaluation .
-
HIV-related lymphoma.
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Major thoracic and/or abdominal surgery within the 4 weeks before randomization from which the patient has not fully recovered except for diagnosis of NHL. Patients who have had minor surgery may be enrolled after a ≥ 1 week recovery period except for diagnosis of NHL.
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Clinically significant cardiovascular abnormalities
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Serious (NCI CTCAE grade 3-4) intercurrent infection at randomization or deep seated or systemic mycotic infections.
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Clinical symptoms suggesting unresolved HIV, HBV or HCV infection. Patients with seropositivity presumed to be due to prior vaccination against Hepatitis B virus or resolved infection will not be excluded.
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Active or history of another malignancy except cured basal cell carcinoma of skin or carcinoma in situ of uterine cervix. Patients who have been in remission from another previous malignancy for >5 years will be considered eligible.
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Known hypersensitivity to the excipients or the study drugs that the patient will receive.
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Any contraindications to the study drugs as described in the Summary of Product Characteristics or package inserts. 13. Neurological contraindication to vincristine (e.g. peripheral neuropathy).
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Any condition which, in the judgment of the Investigator, would place the subject at undue risk, interfere with the results of the study, or make the subject otherwise unsuitable. 15. General status that, in the opinion of the Investigator does not permit the administration of eight courses of CHOP-R/CPOP-R. 16. Treatment with any other investigational study drug within 30 days before randomization. Patient must have recovered from all side effects of other investigational therapy. 17. Potentially fertile men and women and their sexual partners not willing to use adequate contraception as defined by the Investigator during the study and for 6 months after the last day of study drug administration.
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Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 CPOP-R - 2 CHOP-R -
- Primary Outcome Measures
Name Time Method Response Rate Subjects followed for 5 years post treatment
- Secondary Outcome Measures
Name Time Method Overall Survival The interval between the date of randomization and death due to any cause (up to 100 weeks) Overall Survival time frame is from the interval between the date of randomization and death due to any cause and measures the total number of deaths.
Median Progression Free Survival (PFS) From the date of randomization to the first documented disease progression or death (up to 100 weeks) The interval between the date of randomization and the event of disease progression or relapse, institution of a new anticancer treatment or death.
Overall Objective Response Rate Subjects followed for 5 years post treatment Time to Treatment Failure Subjects followed for 5 years post treatment
Trial Locations
- Locations (75)
Western Kentucky Hematology/Oncology Group
🇺🇸Paducah, Kentucky, United States
Hubert H Humphrey Cancer Center
🇺🇸Robbinsdale, Minnesota, United States
Texas Hematology Oncology Center
🇺🇸Dallas, Texas, United States
North Missssppi Hematology Oncology Associates
🇺🇸Tupelo, Mississippi, United States
Tufts-New England Medical Center-The Neely Ctr for Clinical Cancer Research
🇺🇸Boston, Massachusetts, United States
Nevada Cancer Institute
🇺🇸Las Vegas, Nevada, United States
Klinikum der Universitaet zu Koeln
🇩🇪Koeln, Germany
Bay Medical Oncology & Hematology
🇺🇸Concord, California, United States
Broward Oncology Associates
🇺🇸Fort Lauderdale, Florida, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
UCSD Moore's Cancer Center-Blood & Marrow Transplantation Division
🇺🇸La Jolla, California, United States
Columbus Clinic
🇺🇸Columbus, Georgia, United States
Oncology Hematology of Northern Illinois
🇺🇸Gurnee, Illinois, United States
Hazel Hawkins Hospital, Dept. of Medical Oncology
🇺🇸Hollister, California, United States
Klinikum Nurnberg Nord - Medizinische
🇩🇪Nuernberg, Germany
St. Luke's Roosevelt Hospital
🇺🇸New York, New York, United States
Memorial Cancer Institute
🇺🇸Pembroke Pines, Florida, United States
Oncology Partners Network
🇺🇸Cincinnati, Ohio, United States
Oncology Hematology Associates of West Broward
🇺🇸Tamarac, Florida, United States
Frederick Memorial Hospital Cancer Center
🇺🇸Frederick, Maryland, United States
Capital Comprehensive Cancer Care
🇺🇸Jefferson City, Missouri, United States
The Center for Cancer and Blood Disorders
🇺🇸Fort Worth, Texas, United States
Cancer Care Center
🇺🇸New Albany, Indiana, United States
Jacobi Medical Center Phase I Oncology
🇺🇸Bronx, New York, United States
Southeast Nebraska Hematology and Oncology Consultants, P.C.
🇺🇸Lincoln, Nebraska, United States
New Mexico Hematology/Oncology Consultants
🇺🇸Albuquerque, New Mexico, United States
Our Lady of Mercy Medical Center
🇺🇸Bronx, New York, United States
Instituto di Ematologia "Lorenzo e Ariosto"
🇮🇹Bologna, Italy
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Rocky Mountain Cancer Center
🇺🇸Denver, Colorado, United States
Northwest Kaiser Permanente
🇺🇸Portland, Oregon, United States
Sarah Cannon Cancer Center
🇺🇸Nashville, Tennessee, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Hematology/Oncology Group of Orange County
🇺🇸Orange, California, United States
Watson Clinic for Cancer Care and Research
🇺🇸Lakeland, Florida, United States
The Center of Hematology and Oncology
🇺🇸Boca Raton, Florida, United States
Watson Clinic
🇺🇸Lakeland, Florida, United States
Osceola Cancer Center
🇺🇸Kissimmee, Florida, United States
Hematology Oncology Associates of the Treasure Coast
🇺🇸Port Saint Lucie, Florida, United States
Hematology Oncology Specialists
🇺🇸Tampa, Florida, United States
John B. Amos Cancer Center
🇺🇸Columbus, Georgia, United States
Mid-Illinois Hematology & Oncology Associates
🇺🇸Normal, Illinois, United States
Consultants in Blood Disorders and Cancer
🇺🇸Louisville, Kentucky, United States
Our Lady of the Lake Regional Medial Center, Hematology Oncology
🇺🇸Baton Rouge, Louisiana, United States
Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
Maryland Hematology/Oncology Associates, PA
🇺🇸Baltimore, Maryland, United States
Center for Cancer and Blood Disorders, P.C.
🇺🇸Bethesda, Maryland, United States
Farmacia Osepdaliera, Odpedale Umberto I
🇮🇹Mestre, Italy
Brody School of Medicine at East Carolina University - Leo W. Jenkins Cancer Center
🇺🇸Greenville, North Carolina, United States
Interlake Foundation, Inc.
🇺🇸Rochester, New York, United States
Cancer Treatment & Research Mid-Dakota Clinic
🇺🇸Bismarck, North Dakota, United States
Summa Health Systems Hospitals
🇺🇸Akron, Ohio, United States
Barberton Citizen's Hospital
🇺🇸Barberton, Ohio, United States
Dayton Clinical Oncology Program
🇺🇸Dayton, Ohio, United States
Berks Hematology-Oncology Associates Ltd.
🇺🇸Reading, Pennsylvania, United States
Low County Hematology & Oncology
🇺🇸Mount Pleasant, South Carolina, United States
Thompson Cancer Survival Center
🇺🇸Knoxville, Tennessee, United States
Charleston Cancer Center
🇺🇸Charleston, South Carolina, United States
Southwest Regional Cancer Center
🇺🇸Austin, Texas, United States
Northern Utah Hematology Oncology, P.C.
🇺🇸Ogden, Utah, United States
Multicare Oncology Hematology Specialists
🇺🇸Tacoma, Washington, United States
London Health Science Center Regional Care Program
🇨🇦London, Ontario, Canada
The Family Cancer Center
🇺🇸Collierville, Tennessee, United States
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Queen Elizabeth II HSC
🇨🇦Halifax, Canada
Universitaetsklinikum Duesseldorf
🇩🇪Duesseldorf, Germany
CHU Hotel Dieu
🇫🇷Nantes, France
Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
Hopitaux Universitaires de Strabourg - Hopital Hautepierre
🇫🇷Strasbourg, France
Universitaetsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Azienda Ospedaliera Careggi
🇮🇹Firenze, Italy
Uiversita La Sapienza
🇮🇹Roma, Italy
Ospedal V. Cervello
🇮🇹Palermo, Italy
Ospedale Civile
🇮🇹Udine, Italy
Policlinico S. Maria alle Scotte
🇮🇹Siena, Italy