BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CTI BioPharma
ClinicalTrials.gov Identifier:
NCT00088530
First received: July 28, 2004
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows reduced potential for cardiotoxicity in animal models. This cytotoxic agent has structural similarities with mitoxantrone as well as general similarities with anthracyclines (such as the tricyclic central quinoid chromophore).

The primary study objective is to compare the efficacy of BBR 2778 to a selection of single agents. Secondary objectives are to compare the safety and tolerability of BBR 2778 to a selection of single agents, and to assess the pharmacokinetic parameters of BBR 2778 in a subset of this patient population.


Condition Intervention Phase
Lymphoma, Non-Hodgkin
Drug: pixantrone, cyclophosphamide, vincristine, rituximab, prednisone
Drug: Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pixantrone (BBR 2778) Versus Other Chemotherapeutic Agents for Third-line Single Agent Treatment of Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma: A Randomized, Controlled, Phase III Comparative Trial

Resource links provided by NLM:


Further study details as provided by CTI BioPharma:

Primary Outcome Measures:
  • Response [ Time Frame: 84 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • toxicity [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Enrollment: 140
Study Start Date: July 2004
Study Completion Date: July 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: pixantrone, cyclophosphamide, vincristine, rituximab, prednisone
Day 1: pixantrone (150 mg/m2), cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)
Other Name: BBR2778
Active Comparator: 2 Drug: Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab
Day 1: cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed aggressive [de novo or transformed] NHL according to REAL/WHO classification.
  • At least one objectively measurable lesion as demonstrated by CT, spiral CT, or MRI and plain radiograph of the chest (chest x-ray, for chest lesions only) that can be followed for response as target lesion.
  • Relapse after 2 or more prior regimens of chemotherapy
  • ECOG performance status of 0, 1, or 2
  • Adequate hematologic, renal and hepatic function
  • LVEF ≥50% determined by MUGA scan

Exclusion Criteria:

  • Prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 450 mg/m²
  • Prior allogenic stem cell transplant
  • Histological diagnosis of Burkitt lymphoma, lymphoblastic lymphoma or Mantle cell lymphoma
  • Active CNS lymphoma or HIV-related lymphoma.
  • Any chemotherapy, radiotherapy, or other anticancer treatment (including corticosteroid, 10 or more mg/day of prednisone or equivalent) within the 2 weeks before randomization
  • Pregnant women or nursing mothers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088530

  Hide Study Locations
Locations
United States, California
Robert A. Moss, M.D., FACP, Inc.
Fountain Valley, California, United States, 92708
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Florida
Watson Clinic for Cancer Care and Research
Lakeland, Florida, United States, 33805
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, New Mexico
New Mexico Oncology/Hematology
Albuquerque, New Mexico, United States, 87109
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oregon
Northwest Kaiser Permanente
Portland, Oregon, United States, 97227
United States, Utah
Northern Utah Hematology Oncology, P.C.
Ogden, Utah, United States, 84403
Argentina
Clinica Modelo S.A.
Parana, Entre Rios, Argentina, 3100
Centro Oncologico Rosario
Rosario, Santa Fe, Argentina, S2000DSK
Instituto de Investigaciones Clinicas
Rosario, Santa Fe, Argentina, 2000
Hospital Universitario Austral
Buenos Aires, Argentina, B1629AHJ
FUNDALEU - fundacion para combatir le Leucernia
Buenos Aires, Argentina, 1114
Academia Nacional de Medicina
Caba, Argentina, C1425AUM
Hospital Privado Centro Medico de Cordoba S.A.
Cordoba, Argentina, X5016KEH
ISIS Clinica Especializada
Santa Fe, Argentina, S3000FFU
Bulgaria
University Gernal Hospital for Active Treatment "Alexandrovska" - Clinic of Hematology
Sofia, Bulgaria, 1431
National Centre for Hemotransfusion
Sofia, Bulgaria, 1756
University General Hospital for Active Treatment "St. Marina" Clinic of Hematology
Varna, Bulgaria, 9000
Costa Rica
Hospital CIMA San Jose
Escazu, Costa Rica
Ecuador
Hospital Oncologico de Solca
Casilla, Guayaquil, Ecuador, 3623
Hospital Carlos Andrade Marin Oncologia
Quito,, Pinchincha, Ecuador, 17
Hospital Solca Quito
Quito, Ecuador
Estonia
Tartu University Clinics, Hematology Oncology Clinic
Tartu, Estonia, 51014
France
Institute Bergonie
Bordeaux, France, 33076
Centre Hospitalier Lyo Sud, Service d'Hematologie et d'Oncologie
Pierre-Benite, France, 69310
Hopitaux Universitaires de Strabourg - Hopital de Hautepierre
Strasbourg, France, 67200
Germany
Staedtische Kliniken Hoechst
Frankfurt, HE, Germany, 65929
Charite, Campus Benjamin Franklin
Berlin, Germany, 12200
Bekes Megyei Pandy Kalman Korhaz
Gyula, Germany, 5701
Universitatklinik des Saarlandes, Innere Medzin I
Hamburg, Germany, 66421
Westpfalzklinikum Kaiserslautern
Kaiserslautern, Germany, 67653
Klinikum der Universitaet zu Koeln
Koeln, Germany, 50924
Kliniken Maria Hilf GmbH
Moenchengladbach, Germany, 41063
Mutterhaus der Borromaeerinne
Trier, Germany, 54290
Hungary
Szent Laszlo Korhaz
Budapest, Hungary, H-1097
Petz Aladar Megyei Okato Korhaz
Gyor, Hungary, H-9024
Kaposi Mor Megyei Korhaz
Kaposvar, Hungary, H-7400
Pecsi Tudomanyegyetem
Pecs, Hungary, H-7624
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvos-es Gyogy II
Szeged, Hungary, 6701
India
Indo-American Cancer Institute & Research Center
Hyderabaad, AndhPrad, India, 500034
Nizam's Institute of Medical Sciences
Panjagutta, Hyderabad, India, 500082
Manipal Hospital
Bangalore, Karnataka, India, 560017
Shirdi Sai Baba Cancer Hospital, K.M.C. Manipal
Manipal, Karna, India, 576119
Regional Cancer Center
Thiruvananthapuram, Kerla, India, 695011
Bhagwan Mahaveer Cancer Hospital & Research Center
Jaipur, Rajasthan, India, 302017
M.S. Ramaiah Medical College
Bangalore, India, 560 054
Tata Memorial Hospital
Mumbai, India, 400012
Italy
Policlinico S. Orsola, Instituto di Ematologia
Bologna, Italy, 40138
Ospedale Oncologico "A. Businco"
Cagliari, Italy, 09100
Ospedale S. Martino
Genova, Italy, 16132
Universita degli Studi Perugia Policlinico Monteluce
Perugia, Italy, 06122
Azienda Ospedaliera Pisanan "Santana Chiara"
Pisa, Italy, 56126
Azienda ospedaliera Pisana "Santa Chiara"
Pisa, Italy, 56126
Ospedale Oncolgoico Regionale della Basilicata
Rionero in Vulture, Italy, 85028
Universita La Sapienza
Roma, Italy, 00161
Ospedale S. Eugenio
Roma, Italy, 00144
Ospedale Casa Sollievo della Sofferenza
S. Giovanni Rotondo, Italy
Policlinico S. Maria alle Scotte
Siena, Italy, 53100
Presidio San Giuseppe Moscati
Taranto, Italy, 74100
Ospedale Civile
Udine, Italy, 33100
Mexico
Fundacion Centro De Investigacion
Medellin, Columbia, Mexico
Medical Solutions
Guatemala, Mexico
Panama
Complejo Hospitalario "Arnulfo Arias Madrid
Panama, Panama
Peru
Onococenter
Sanborja, Lima, Peru
Hospital Edgardo Rebagliati Martins
Lima, Peru, 11
Poland
Klinika Hematologii, Onkologii i Chorob Wewnetrznych
Gdansk, Poland, 80-211
Romania
Brasov Counthy Hospital
Brasov, Romania, 500326
Fundei Clinical Institute
Bucharest, Romania, 022328
Colentina Clinical Hospital Hem Dept
Bucharest, Romania, 020125
Prof. Dr. Ian Chiricuta, Institute of Oncology, Radiotheraphy
Cluj Napoca, Romania, 400015
Institutul Oncologic "Ion Chiricuta" Oncologie Medicala
Cluj-Napoca, Romania, 400015
Mures County Clinical Hospital
Targu Mures, Romania, 540136
Russian Federation
State Medical Institution Altai Territorial Oncological Center
Barnaul, Russian Federation, 656049
State Therapeutical & Prophlatic Institution: Cheylabinsk Regional Oncological Center
Chelyabinsk, Russian Federation, 454087
State Medical Institution
Irkutsk, Russian Federation, 664035
State Medical Institution: Clinical Oncological Center
Krasnodar, Russian Federation, 350040
Russian Oncological Research Center n.a. N.N. Blokhin
Moscow, Russian Federation, 115478
State Institution: Moscow Regional Research Clinical institute n.a. M.F.
Moscow, Russian Federation, 129110
Semashko Central Clinical Hospital
Moscow, Russian Federation, 129128
State Institution: Hematological Research Center under the Russian Academy of Medical Sciences
Moscow, Russian Federation, 125167
Medical Radiological Research Center under the Russian academey of Medical Sciences
Obninsk, Russian Federation, 249036
State Medical Institution Replubican Oncological Center
Republic of Bashkortostan, Russian Federation, 450054
Research Insitute of Hematology and Blood Transfusion
St. Petersburg, Russian Federation, 191024
St. Petersburg Pavlov State Medical Clinic of Intensive Care & Bone Marrow Transplantation
St. Petersburg, Russian Federation, 197022
Central Research Rontgenological and Radiological Institute
St. Petersburg, Russian Federation, 197758
St. Petersburg State Medical Institution: Municipal Hospital #31
St. Petersburg, Russian Federation, 197110
State Research Institution: Research Institute of Oncology
St. Petersburg, Russian Federation, 197758
St. Petersburg State Medical univ. n.a. I.P. Pavlov
St. Petersburg, Russian Federation, 197022
Ukraine
Kyiv Bone Marrow Transplantation
Kyiv, Ukraine, 03115
Institute of Clinical Radiology of the Research Center for Radiation Medicine under the UAMS
Kyiv, Ukraine, 03115
Institute of Blood Pathology & Transfusion Medicine under the UAMS
Lviv, Ukraine, 79044
Zhtomyr O.F. Gerbachevsky Regional Hospital
Zhitomyr, Ukraine, 10002
United Kingdom
Beatson Oncology Centre, Western Infirmary
Glasgow, United Kingdom, G11 6T
St. Georges Hospital
London, United Kingdom, SW17 0QT
Weston Park Hospital
Sheffield, United Kingdom, S10 2Sj
Uruguay
Hospital Maciel
Montevideo, Uruguay, 11000
Hospital Policial de Montevideo
Quinto Piso Montevideo, Uruguay, 12000
Sponsors and Collaborators
CTI BioPharma
  More Information

Additional Information:
No publications provided by CTI BioPharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CTI BioPharma
ClinicalTrials.gov Identifier: NCT00088530     History of Changes
Obsolete Identifiers: NCT00101049
Other Study ID Numbers: PIX301
Study First Received: July 28, 2004
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by CTI BioPharma:
Pixantrone
Non-Hodgkins lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Pixantrone
Prednisone
Rituximab
Vincristine
Alkylating Agents
Anti-Inflammatory Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists

ClinicalTrials.gov processed this record on October 29, 2014