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

January 15, 2015 updated by: CTI BioPharma

Cyclophosphamide, Doxorubicin, Vincristine, Prednisone Plus Rituximab (CHOP-R) and Cyclophosphamide, Pixantrone, Vincristine, Prednisone Plus Rituximab (CPOP-R) in Patients With Diffuse Large-B-cell Lymphoma: A Phase II, Randomized, Multicenter, Comparative Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Halifax, Canada, NS B3H 1V8
        • Queen Elizabeth II HSC
    • Ontario
      • London, Ontario, Canada, N6A4L6
        • London Health Science Center Regional Care Program
      • Ottawa, Ontario, Canada, K1H8L6
        • The Ottawa Hospital
  • France
      • Nantes, France, 44000
        • Chu Hotel Dieu
      • Strasbourg, France, 67200
        • Hopitaux Universitaires de Strabourg - Hopital Hautepierre
  • Germany
      • Dresden, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus
      • Duesseldorf, Germany, 40225
        • Universitaetsklinikum Duesseldorf
      • Koeln, Germany, 50924
        • Klinikum der Universitaet zu Koeln
      • Nuernberg, Germany, 90419
        • Klinikum Nurnberg Nord - Medizinische
      • Wuerzburg, Germany, 97080
        • Universitaetsklinikum Wuerzburg
  • Italy
      • Bologna, Italy, 40138
        • Instituto di Ematologia "Lorenzo e Ariosto"
      • Firenze, Italy, 50139
        • Azienda Ospedaliera Careggi
      • Mestre, Italy, 30173
        • Farmacia Osepdaliera, Odpedale Umberto I
      • Palermo, Italy, 90146
        • Ospedal V. Cervello
      • Roma, Italy, 00161
        • Uiversita La Sapienza
      • Siena, Italy, 53100
        • Policlinico S. Maria alle Scotte
      • Udine, Italy, 33100
        • Ospedale Civile
  • United States
    • California
      • Concord, California, United States, 94520
        • Bay Medical Oncology & Hematology
      • Hollister, California, United States, 95020
        • Hazel Hawkins Hospital, Dept. of Medical Oncology
      • La Jolla, California, United States, 92093
        • UCSD Moore's Cancer Center-Blood & Marrow Transplantation Division
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • Orange, California, United States, 92868
        • Hematology/Oncology Group of Orange County
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
    • Florida
      • Boca Raton, Florida, United States, 33486
        • The Center of Hematology and Oncology
      • Ft. Lauderdale, Florida, United States, 33308
        • Broward Oncology Associates
      • Kissimmee, Florida, United States, 34741
        • Osceola Cancer Center
      • Lakeland, Florida, United States, 33805
        • Watson Clinic
      • Lakeland, Florida, United States, 33805
        • Watson Clinic for Cancer Care and Research
      • Pembroke Pines, Florida, United States, 33028
        • Memorial Cancer Institute
      • Port St. Lucie, Florida, United States, 34952
        • Hematology Oncology Associates of the Treasure Coast
      • Tamarac, Florida, United States, 33321
        • Oncology Hematology Associates of West Broward
      • Tampa, Florida, United States, 33607
        • Hematology Oncology Specialists
    • Georgia
      • Columbus, Georgia, United States, 31904
        • John B. Amos Cancer Center
      • Columbus, Georgia, United States, 39101
        • Columbus Clinic
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Oncology Hematology of Northern Illinois
      • Normal, Illinois, United States, 61761
        • Mid-Illinois Hematology & Oncology Associates
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Consultants in Blood Disorders and Cancer
      • Paducah, Kentucky, United States, 42003
        • Western Kentucky Hematology/Oncology Group
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady of the Lake Regional Medial Center, Hematology Oncology
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
      • Baltimore, Maryland, United States, 21237
        • Maryland Hematology/Oncology Associates, PA
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders, P.C.
      • Frederick, Maryland, United States, 21701
        • Frederick Memorial Hospital Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts-New England Medical Center-The Neely Ctr for Clinical Cancer Research
    • Minnesota
      • Robbinsdale, Minnesota, United States, 55422
        • Hubert H Humphrey Cancer Center
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North Missssppi Hematology Oncology Associates
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Capital Comprehensive Cancer Care
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Southeast Nebraska Hematology and Oncology Consultants, P.C.
    • Nevada
      • Las Vegas, Nevada, United States, 89135
        • Nevada Cancer Institute
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • New Mexico Hematology/Oncology Consultants
    • New York
      • Bronx, New York, United States, 10466
        • Our Lady of Mercy Medical Center
      • Bronx, New York, United States, 10461
        • Jacobi Medical Center Phase I Oncology
      • New Albany, New York, United States, 47150
        • Cancer Care Center
      • New York City, New York, United States, 10019
        • St. Luke's Roosevelt Hospital
      • Rochester, New York, United States, 14623
        • Interlake Foundation, Inc.
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Greenville, North Carolina, United States, 27858
        • Brody School of Medicine at East Carolina University - Leo W. Jenkins Cancer Center
    • North Dakota
      • Bismark, North Dakota, United States, 58501
        • Cancer Treatment & Research Mid-Dakota Clinic
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health Systems Hospitals
      • Barberton, Ohio, United States, 44203
        • Barberton Citizen's Hospital
      • Cincinnati, Ohio, United States, 45257
        • Oncology Partners Network
      • Dayton, Ohio, United States, 45429
        • Dayton Clinical Oncology Program
    • Oregon
      • Portland, Oregon, United States, 97227
        • Northwest Kaiser Permanente
    • Pennsylvania
      • Reading, Pennsylvania, United States, 19612
        • Berks Hematology-Oncology Associates Ltd.
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Charleston Cancer Center
      • Mount Pleasant, South Carolina, United States, 29464
        • Low County Hematology & Oncology
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • The Family Cancer Center
      • Knoxville, Tennessee, United States, 37916
        • Thompson Cancer Survival Center
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Cancer Center
    • Texas
      • Austin, Texas, United States, 78705
        • Southwest Regional Cancer Center
      • Dallas, Texas, United States, 75234
        • Texas Hematology Oncology Center
      • Fort Worth, Texas, United States, 76104
        • The Center for Cancer and Blood Disorders
    • Utah
      • Ogden, Utah, United States, 84403
        • Northern Utah Hematology Oncology, P.C.
    • Washington
      • Tacoma, Washington, United States, 98405
        • Multicare Oncology Hematology Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Previously untreated and histologically confirmed diffuse large B-cell lymphoma according to REAL/WHO classification.
  2. Stage II, III or IV disease
  3. CD20+
  4. Age ≥ 18 years
  5. ECOG performance status ≤ 2

  6. 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.
  7. Life expectancy ≥ 3 months
  8. 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.
  9. LVEF ≥ 50% determined by MUGA scan.
  10. Ability to comply with the visit schedule and assessments required by the protocol.
  11. Signed approved informed consent, with understanding of study procedures.

Exclusion Criteria:

  1. 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.
  2. Histological diagnosis of T-cell lymphoma or any B-cell lymphoma other than diffuse large B-cell.
  3. History of indolent lymphoma
  4. Active CNS involvement based on clinical evaluation .
  5. HIV-related lymphoma.
  6. 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.
  7. Clinically significant cardiovascular abnormalities
  8. Serious (NCI CTCAE grade 3-4) intercurrent infection at randomization or deep seated or systemic mycotic infections.
  9. 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.
  10. 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.
  11. Known hypersensitivity to the excipients or the study drugs that the patient will receive.
  12. 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).

14. 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.

18. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: CPOP-R
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
Active Comparator: 2
Drug: CHOP-R
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective is to show that the response rate for CPOP-R is not inferior to that of CHOP-R.
Time Frame: Subjects followed for 5 years post treatment
Subjects followed for 5 years post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary objective is to compare the overall survival, event free survival and cardiac safety of the 2 treatments. Other comparisons will include duration of response, overall objective response rate, and time to treatment failure (TTF).
Time Frame: Subjects followed for 5 years post treatment
Subjects followed for 5 years post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CTI BioPharma

Investigators

  • Study Director: Gabor Jurida, M.D., CTI BioPharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

December 21, 2005

First Submitted That Met QC Criteria

December 21, 2005

First Posted (Estimate)

December 23, 2005

Study Record Updates

Last Update Posted (Estimate)

January 19, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIX203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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