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

January 27, 2020 updated by: CTI BioPharma

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 3

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

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

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:

  • 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

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: Experimental Arm
Pixantrone (BBR2778)
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 Names:
  • BBR2778
Active Comparator: Comparator Arm
To be chosen by the investigator, among vinorelbine, oxaliplatin, ifosfamide, etoposide or mitoxantrone
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response (CR) and Complete Response Unconfirmed (CRu)
Time Frame: EOT; approximately 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: 18 months after 6 cycles of treatment; approximately 24 months
The time between the date of randomization and the date of the initial documentation of progressive/relapsed disease or death due to any cause.
18 months after 6 cycles of treatment; approximately 24 months
Overall Survival
Time Frame: 18 months after 6 cycles of treatment; approximately 24 months
The time between the date of randomization and the date of death due to any cause.
18 months after 6 cycles of treatment; approximately 24 months
Overall Response Rate (ORR) Lasting at Least 4 Months
Time Frame: approximately 24 months
The proportion of patients with Complete response or Partial Response with a difference from the first documented objective response to disease progression or death of at least 4 months.
approximately 24 months

Collaborators and Investigators

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

Sponsor

CTI BioPharma

Investigators

  • Study Director: Simran Singh, Sr. Director, Clinical Operations

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

July 1, 2004

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

July 28, 2004

First Submitted That Met QC Criteria

July 28, 2004

First Posted (Estimate)

July 29, 2004

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIX301

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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