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

NCT00088530 | Completed Phase 3 Results DMC

• 1 other identifier: PIX301
• Study Type: interventional
• Target: 140
• Locations: 20 countries
• Sites: 99

Brief Summary

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).

Conditions

Lymphoma, Non-Hodgkin

Keywords

Pixantrone; Non-Hodgkins lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete Response (CR) and Complete Response Unconfirmed (CRu)

  Proportion of patients with a best response of complete response (CR) or Complete Response unconfirmed (CRu) in the End Of Treatment (EOT) or End Of Study (EOS) analyses by independent assessment in the Intent-to-treat (ITT) population through the End of Treatment (EOT)

  EOT; approximately 6 months

Secondary Outcomes (3)

• Progression-Free Survival (PFS)

  18 months after 6 cycles of treatment; approximately 24 months

• Overall Survival

  18 months after 6 cycles of treatment; approximately 24 months

• Overall Response Rate (ORR) Lasting at Least 4 Months

  approximately 24 months

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Pixantrone (BBR2778)

Drug: pixantrone, cyclophosphamide, vincristine, rituximab, prednisone

Comparator Arm

ACTIVE COMPARATOR

To be chosen by the investigator, among vinorelbine, oxaliplatin, ifosfamide, etoposide or mitoxantrone

Drug: Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab

Interventions

pixantrone, cyclophosphamide, vincristine, rituximab, prednisone DRUG

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)

Also known as: BBR2778

Experimental Arm

Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab DRUG

Day 1: cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)

Comparator Arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CTI BioPharma: lead

Study Sites (99)

Robert A. Moss, M.D., FACP, Inc.

Fountain Valley, California, 92708, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Watson Clinic for Cancer Care and Research

Lakeland, Florida, 33805, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

New Mexico Oncology/Hematology

Albuquerque, New Mexico, 87109, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Northwest Kaiser Permanente

Portland, Oregon, 97227, United States

Location

Northern Utah Hematology Oncology, P.C.

Ogden, Utah, 84403, United States

Location

Clinica Modelo S.A.

Paraná, Entre Ríos Province, 3100, Argentina

Location

Instituto de Investigaciones Clinicas

Rosario, Santa Fe Province, 2000, Argentina

Location

Centro Oncologico Rosario

Rosario, Santa Fe Province, S2000DSK, Argentina

Location

FUNDALEU - fundacion para combatir le Leucernia

Buenos Aires, 1114, Argentina

Location

Hospital Universitario Austral

Buenos Aires, B1629AHJ, Argentina

Location

Academia Nacional de Medicina

Caba, C1425AUM, Argentina

Location

Hospital Privado Centro Medico de Cordoba S.A.

Córdoba, X5016KEH, Argentina

Location

ISIS Clinica Especializada

Santa Fe, S3000FFU, Argentina

Location

University Gernal Hospital for Active Treatment "Alexandrovska" - Clinic of Hematology

Sofia, 1431, Bulgaria

Location

National Centre for Hemotransfusion

Sofia, 1756, Bulgaria

Location

University General Hospital for Active Treatment "St. Marina" Clinic of Hematology

Varna, 9000, Bulgaria

Location

Hospital CIMA San Jose

Escazú, Costa Rica

Location

Hospital Oncologico de Solca

Capilla Mauta, Guayaquil, 3623, Ecuador

Location

Hospital Carlos Andrade Marin Oncologia

Quito, Pinchincha, 17, Ecuador

Location

Hospital Solca Quito

Quito, Ecuador

Location

Tartu University Clinics, Hematology Oncology Clinic

Tartu, 51014, Estonia

Location

Institute Bergonie

Bordeaux, 33076, France

Location

Centre Hospitalier Lyo Sud, Service d'Hematologie et d'Oncologie

Pierre-Bénite, 69310, France

Location

Hopitaux Universitaires de Strabourg - Hopital de Hautepierre

Strasbourg, 67200, France

Location

Staedtische Kliniken Hoechst

Frankfurt am Main, Hesse, 65929, Germany

Location

Charite, Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Klinikum der Universitaet zu Koeln

Cologne, 50924, Germany

Location

Universitatklinik des Saarlandes, Innere Medzin I

Hamburg, 66421, Germany

Location

Westpfalzklinikum Kaiserslautern

Kaiserslautern, 67653, Germany

Location

Kliniken Maria Hilf GmbH

Mönchengladbach, 41063, Germany

Location

Mutterhaus der Borromaeerinne

Trier, 54290, Germany

Location

Szent Laszlo Korhaz

Budapest, H-1097, Hungary

Location

Petz Aladar Megyei Okato Korhaz

Győr, H-9024, Hungary

Location

Bekes Megyei Pandy Kalman Korhaz

Gyula, 5701, Hungary

Location

Kaposi Mor Megyei Korhaz

Kaposvár, H-7400, Hungary

Location

Pecsi Tudomanyegyetem

Pécs, H-7624, Hungary

Location

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvos-es Gyogy II

Szeged, 6701, Hungary

Location

Indo-American Cancer Institute & Research Center

Hyderabaad, AndhPrad, 500034, India

Location

Nizam's Institute of Medical Sciences

Panjagutta, Hyderabad, 500082, India

Location

Manipal Hospital

Bangalore, Karnataka, 560017, India

Location

Shirdi Sai Baba Cancer Hospital, K.M.C. Manipal

Manipal, Karna, 576119, India

Location

Regional Cancer Center

Thiruvananthapuram, Kerla, 695011, India

Location

Bhagwan Mahaveer Cancer Hospital & Research Center

Jaipur, Rajasthan, 302017, India

Location

M.S. Ramaiah Medical College

Bangalore, 560 054, India

Location

Tata Memorial Hospital

Mumbai, 400012, India

Location

Policlinico S. Orsola, Instituto di Ematologia

Bologna, 40138, Italy

Location

Ospedale Oncologico "A. Businco"

Cagliari, 09100, Italy

Location

Ospedale S. Martino

Genova, 16132, Italy

Location

Universita degli Studi Perugia Policlinico Monteluce

Perugia, 06122, Italy

Location

Azienda ospedaliera Pisana "Santa Chiara"

Pisa, 56126, Italy

Location

Azienda Ospedaliera Pisanan "Santana Chiara"

Pisa, 56126, Italy

Location

Ospedale Oncolgoico Regionale della Basilicata

Rionero in Vulture, 85028, Italy

Location

Ospedale S. Eugenio

Roma, 00144, Italy

Location

Universita La Sapienza

Roma, 00161, Italy

Location

Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Location

Policlinico S. Maria alle Scotte

Siena, 53100, Italy

Location

Presidio San Giuseppe Moscati

Taranto, 74100, Italy

Location

Ospedale Civile

Udine, 33100, Italy

Location

Fundacion Centro De Investigacion

Medellín, Columbia, Mexico

Location

Medical Solutions

Guatemala, Guatemala, Mexico

Location

Complejo Hospitalario "Arnulfo Arias Madrid

Panama City, Panama

Location

Hospital Edgardo Rebagliati Martins

Lima, 11, Peru

Location

Onococenter

San Borja, Peru

Location

Klinika Hematologii, Onkologii i Chorob Wewnetrznych

Gdansk, 80-211, Poland

Location

Brasov Counthy Hospital

Brasov, 500326, Romania

Location

Colentina Clinical Hospital Hem Dept

Bucharest, 020125, Romania

Location

Fundei Clinical Institute

Bucharest, 022328, Romania

Location

Institutul Oncologic "Ion Chiricuta" Oncologie Medicala

Cluj-Napoca, 400015, Romania

Location

Prof. Dr. Ian Chiricuta, Institute of Oncology, Radiotheraphy

Cluj-Napoca, 400015, Romania

Location

Mures County Clinical Hospital

Târgu Mureş, 540136, Romania

Location

State Medical Institution Altai Territorial Oncological Center

Barnaul, 656049, Russia

Location

State Medical Institution Replubican Oncological Center

Bashkortostan, 450054, Russia

Location

State Therapeutical & Prophlatic Institution: Cheylabinsk Regional Oncological Center

Chelyabinsk, 454087, Russia

Location

State Medical Institution

Irkutsk, 664035, Russia

Location

State Medical Institution: Clinical Oncological Center

Krasnodar, 350040, Russia

Location

Russian Oncological Research Center n.a. N.N. Blokhin

Moscow, 115478, Russia

Location

State Institution: Hematological Research Center under the Russian Academy of Medical Sciences

Moscow, 125167, Russia

Location

State Institution: Moscow Regional Research Clinical institute n.a. M.F.

Moscow, 129110, Russia

Location

Semashko Central Clinical Hospital

Moscow, 129128, Russia

Location

Medical Radiological Research Center under the Russian academey of Medical Sciences

Obninsk, 249036, Russia

Location

Research Insitute of Hematology and Blood Transfusion

Saint Petersburg, 191024, Russia

Location

St. Petersburg Pavlov State Medical Clinic of Intensive Care & Bone Marrow Transplantation

Saint Petersburg, 197022, Russia

Location

St. Petersburg State Medical univ. n.a. I.P. Pavlov

Saint Petersburg, 197022, Russia

Location

St. Petersburg State Medical Institution: Municipal Hospital #31

Saint Petersburg, 197110, Russia

Location

Central Research Rontgenological and Radiological Institute

Saint Petersburg, 197758, Russia

Location

State Research Institution: Research Institute of Oncology

Saint Petersburg, 197758, Russia

Location

Institute of Clinical Radiology of the Research Center for Radiation Medicine under the UAMS

Kyiv, 03115, Ukraine

Location

Kyiv Bone Marrow Transplantation

Kyiv, 03115, Ukraine

Location

Institute of Blood Pathology & Transfusion Medicine under the UAMS

Lviv, 79044, Ukraine

Location

Zhtomyr O.F. Gerbachevsky Regional Hospital

Zhytomyr, 10002, Ukraine

Location

Beatson Oncology Centre, Western Infirmary

Glasgow, G11 6T, United Kingdom

Location

St. Georges Hospital

London, SW17 0QT, United Kingdom

Location

Weston Park Hospital

Sheffield, S10 2Sj, United Kingdom

Location

Hospital Maciel

Montevideo, 11000, Uruguay

Location

Hospital Policial de Montevideo

Poblado Montevideo Chico, 12000, Uruguay

Location

Related Publications (1)

• Pettengell R, Coiffier B, Narayanan G, de Mendoza FH, Digumarti R, Gomez H, Zinzani PL, Schiller G, Rizzieri D, Boland G, Cernohous P, Wang L, Kuepfer C, Gorbatchevsky I, Singer JW. Pixantrone dimaleate versus other chemotherapeutic agents as a single-agent salvage treatment in patients with relapsed or refractory aggressive non-Hodgkin lymphoma: a phase 3, multicentre, open-label, randomised trial. Lancet Oncol. 2012 Jul;13(7):696-706. doi: 10.1016/S1470-2045(12)70212-7. Epub 2012 May 30.

  PMID: 22652183 DERIVED

Related Links

• CTI company website

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

pixantrone; Cyclophosphamide; Vincristine; Rituximab; Prednisone; Vinorelbine; Etoposide; Gemcitabine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Glucosides; Glycosides; Carbohydrates; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Simran Bedi Singh
• Organization: CTIBioPharma Corp.

ssingh@ctibiopharma.com

(206) 272-4000

Study Officials

• Simran Singh

  Sr. Director, Clinical Operations

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2004
• First Posted: July 29, 2004
• Study Start: July 1, 2004
• Primary Completion: February 1, 2010
• Study Completion: July 1, 2010
• Last Updated: February 5, 2020
• Results First Posted: June 1, 2017

Record last verified: 2020-01

Locations

IT (13); RO (6); GB (3); PA (1); FR (3); HU (6); CO (1); UR (2); PL (1); EC (3); PE (2); DE (7); US (9); BU (3); ES (1); AR (8); UA (4); RU (16); ME (2); IN (8)