A Trial in Patients With Diffuse Large-B-cell Lymphoma Comparing Pixantrone Against Doxorubicin

NCT00268853 | Completed Phase 2 Results DMC

• 1 other identifier: PIX203
• Study Type: interventional
• Target: 124
• Locations: 5 countries
• Sites: 75

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.

Conditions

Diffuse Large-Cell Lymphoma

Keywords

lymphoma; NHL; large cell; phase II; CHOP R; CPOP R; non Hodgkins

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Subjects followed for 5 years post treatment

Secondary Outcomes (4)

• Overall Survival

  The interval between the date of randomization and death due to any cause (up to 100 weeks)

• Median Progression Free Survival (PFS)

  From the date of randomization to the first documented disease progression or death (up to 100 weeks)

• Overall Objective Response Rate

  Subjects followed for 5 years post treatment

• Time to Treatment Failure

  Subjects followed for 5 years post treatment

Study Arms (2)

1

EXPERIMENTAL

Drug: CPOP-R

2

ACTIVE COMPARATOR

Drug: CHOP-R

Interventions

CPOP-R DRUG

Cyclophosphamide 750 mg/m2, pixantrone 150 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles

1

CHOP-R DRUG

Cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated and histologically confirmed diffuse large B-cell lymphoma according to REAL/WHO classification.
• Stage II, III or IV disease
• CD20+
• Age ≥ 18 years
• ECOG performance status ≤ 2
• 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.
• LVEF ≥ 50% determined by MUGA scan.
• Ability to comply with the visit schedule and assessments required by the protocol.
• Signed approved informed consent, with understanding of study procedures.

You may not qualify if:

• 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.
• Histological diagnosis of T-cell lymphoma or any B-cell lymphoma other than diffuse large B-cell.
• History of indolent lymphoma
• Active CNS involvement based on clinical evaluation .
• HIV-related lymphoma.
• 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.
• Clinically significant cardiovascular abnormalities
• Serious (NCI CTCAE grade 3-4) intercurrent infection at randomization or deep seated or systemic mycotic infections.
• 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.
• 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.
• Known hypersensitivity to the excipients or the study drugs that the patient will receive.
• 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).
• \. 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.
• \. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.

Sponsors & Collaborators

• CTI BioPharma: lead

Study Sites (75)

Bay Medical Oncology & Hematology

Concord, California, 94520, United States

Location

Hazel Hawkins Hospital, Dept. of Medical Oncology

Hollister, California, 95020, United States

Location

UCSD Moore's Cancer Center-Blood & Marrow Transplantation Division

La Jolla, California, 92093, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Hematology/Oncology Group of Orange County

Orange, California, 92868, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

The Center of Hematology and Oncology

Boca Raton, Florida, 33486, United States

Location

Broward Oncology Associates

Fort Lauderdale, Florida, 33308, United States

Location

Osceola Cancer Center

Kissimmee, Florida, 34741, United States

Location

Watson Clinic for Cancer Care and Research

Lakeland, Florida, 33805, United States

Location

Watson Clinic

Lakeland, Florida, 33805, United States

Location

Memorial Cancer Institute

Pembroke Pines, Florida, 33028, United States

Location

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, 34952, United States

Location

Oncology Hematology Associates of West Broward

Tamarac, Florida, 33321, United States

Location

Hematology Oncology Specialists

Tampa, Florida, 33607, United States

Location

John B. Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

Columbus Clinic

Columbus, Georgia, 39101, United States

Location

Oncology Hematology of Northern Illinois

Gurnee, Illinois, 60031, United States

Location

Mid-Illinois Hematology & Oncology Associates

Normal, Illinois, 61761, United States

Location

Cancer Care Center

New Albany, Indiana, 47150, United States

Location

Consultants in Blood Disorders and Cancer

Louisville, Kentucky, 40207, United States

Location

Western Kentucky Hematology/Oncology Group

Paducah, Kentucky, 42003, United States

Location

Our Lady of the Lake Regional Medial Center, Hematology Oncology

Baton Rouge, Louisiana, 70808, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Maryland Hematology/Oncology Associates, PA

Baltimore, Maryland, 21237, United States

Location

Center for Cancer and Blood Disorders, P.C.

Bethesda, Maryland, 20817, United States

Location

Frederick Memorial Hospital Cancer Center

Frederick, Maryland, 21701, United States

Location

Tufts-New England Medical Center-The Neely Ctr for Clinical Cancer Research

Boston, Massachusetts, 02111, United States

Location

Hubert H Humphrey Cancer Center

Robbinsdale, Minnesota, 55422, United States

Location

North Missssppi Hematology Oncology Associates

Tupelo, Mississippi, 38801, United States

Location

Capital Comprehensive Cancer Care

Jefferson City, Missouri, 65109, United States

Location

Southeast Nebraska Hematology and Oncology Consultants, P.C.

Lincoln, Nebraska, 68510, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

New Mexico Hematology/Oncology Consultants

Albuquerque, New Mexico, 87109, United States

Location

St. Luke's Roosevelt Hospital

New York, New York, 10019, United States

Location

Interlake Foundation, Inc.

Rochester, New York, 14623, United States

Location

Jacobi Medical Center Phase I Oncology

The Bronx, New York, 10461, United States

Location

Our Lady of Mercy Medical Center

The Bronx, New York, 10466, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Brody School of Medicine at East Carolina University - Leo W. Jenkins Cancer Center

Greenville, North Carolina, 27858, United States

Location

Cancer Treatment & Research Mid-Dakota Clinic

Bismarck, North Dakota, 58501, United States

Location

Summa Health Systems Hospitals

Akron, Ohio, 44304, United States

Location

Barberton Citizen's Hospital

Barberton, Ohio, 44203, United States

Location

Oncology Partners Network

Cincinnati, Ohio, 45257, United States

Location

Dayton Clinical Oncology Program

Dayton, Ohio, 45429, United States

Location

Northwest Kaiser Permanente

Portland, Oregon, 97227, United States

Location

Berks Hematology-Oncology Associates Ltd.

Reading, Pennsylvania, 19612, United States

Location

Charleston Cancer Center

Charleston, South Carolina, 29406, United States

Location

Low County Hematology & Oncology

Mt. Pleasant, South Carolina, 29464, United States

Location

The Family Cancer Center

Collierville, Tennessee, 38017, United States

Location

Thompson Cancer Survival Center

Knoxville, Tennessee, 37916, United States

Location

Sarah Cannon Cancer Center

Nashville, Tennessee, 37203, United States

Location

Southwest Regional Cancer Center

Austin, Texas, 78705, United States

Location

Texas Hematology Oncology Center

Dallas, Texas, 75234, United States

Location

The Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

Northern Utah Hematology Oncology, P.C.

Ogden, Utah, 84403, United States

Location

Multicare Oncology Hematology Specialists

Tacoma, Washington, 98405, United States

Location

London Health Science Center Regional Care Program

London, Ontario, N6A4L6, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Location

Queen Elizabeth II HSC

Halifax, NS B3H 1V8, Canada

Location

CHU Hotel Dieu

Nantes, 44000, France

Location

Hopitaux Universitaires de Strabourg - Hopital Hautepierre

Strasbourg, 67200, France

Location

Klinikum der Universitaet zu Koeln

Cologne, 50924, Germany

Location

Universitaetsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Universitaetsklinikum Duesseldorf

Düsseldorf, 40225, Germany

Location

Klinikum Nurnberg Nord - Medizinische

Nuremberg, 90419, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, 97080, Germany

Location

Instituto di Ematologia "Lorenzo e Ariosto"

Bologna, 40138, Italy

Location

Azienda Ospedaliera Careggi

Florence, 50139, Italy

Location

Farmacia Osepdaliera, Odpedale Umberto I

Mestre, 30173, Italy

Location

Ospedal V. Cervello

Palermo, 90146, Italy

Location

Uiversita La Sapienza

Roma, 00161, Italy

Location

Policlinico S. Maria alle Scotte

Siena, 53100, Italy

Location

Ospedale Civile

Udine, 33100, Italy

Location

Related Publications (1)

• Herbrecht R, Cernohous P, Engert A, Le Gouill S, Macdonald D, Machida C, Myint H, Saleh A, Singer J, Wilhelm M, van der Jagt R. Comparison of pixantrone-based regimen (CPOP-R) with doxorubicin-based therapy (CHOP-R) for treatment of diffuse large B-cell lymphoma. Ann Oncol. 2013 Oct;24(10):2618-2623. doi: 10.1093/annonc/mdt289. Epub 2013 Aug 14.

  PMID: 23946328 RESULT

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma

Interventions

R-CHOP protocol

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Anton Egorov, Associate Project Director Clinical Development
• Organization: Institut de Recherches Internationales Servier

anton.egorov@servier.com

+33 1 55 72 31 94

Study Officials

• Gabor Jurida, M.D.

  CTI BioPharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2005
• First Posted: December 23, 2005
• Study Start: November 1, 2005
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 30, 2024
• Results First Posted: May 30, 2024

Record last verified: 2024-05

Locations

FR (2); US (58); IT (7); CA (3); DE (5)