Clinical trial NCT00088530: BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lymphoma, Non-Hodgkin
Keywords: Pixantrone
Non-Hodgkins lymphoma
Lead sponsor: CTI BioPharma
Sponsor class: INDUSTRY
First posted: 2004-07-29
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Complete Response (CR) and Complete Response Unconfirmed (CRu)
timeFrame: EOT; approximately 6 months
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 18 months after 6 cycles of treatment; approximately 24 months
measure: Overall Survival
timeFrame: 18 months after 6 cycles of treatment; approximately 24 months
measure: Overall Response Rate (ORR) Lasting at Least 4 Months
timeFrame: approximately 24 months
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Robert A. Moss, M.D., FACP, Inc.
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Lakeland
country: United States
facility: Watson Clinic for Cancer Care and Research
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Albuquerque
country: United States
facility: New Mexico Oncology/Hematology
state: New Mexico
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Northwest Kaiser Permanente
state: Oregon
city: Ogden
country: United States
facility: Northern Utah Hematology Oncology, P.C.
state: Utah
city: Parana
country: Argentina
facility: Clinica Modelo S.A.
state: Entre Rios
city: Rosario
country: Argentina
facility: Instituto de Investigaciones Clinicas
state: Santa Fe
city: Rosario
country: Argentina
facility: Centro Oncologico Rosario
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: FUNDALEU - fundacion para combatir le Leucernia
city: Buenos Aires
country: Argentina
facility: Hospital Universitario Austral
city: Caba
country: Argentina
facility: Academia Nacional de Medicina
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba S.A.
city: Santa Fe
country: Argentina
facility: ISIS Clinica Especializada
city: Sofia
country: Bulgaria
facility: University Gernal Hospital for Active Treatment "Alexandrovska" - Clinic of Hematology
city: Sofia
country: Bulgaria
facility: National Centre for Hemotransfusion
city: Varna
country: Bulgaria
facility: University General Hospital for Active Treatment "St. Marina" Clinic of Hematology
city: Escazu
country: Costa Rica
facility: Hospital CIMA San Jose
city: Capilla Mauta
country: Ecuador
facility: Hospital Oncologico de Solca
state: Guayaquil
city: Quito,
country: Ecuador
facility: Hospital Carlos Andrade Marin Oncologia
state: Pinchincha
city: Quito
country: Ecuador
facility: Hospital Solca Quito
city: Tartu
country: Estonia
facility: Tartu University Clinics, Hematology Oncology Clinic
city: Bordeaux
country: France
facility: Institute Bergonie
city: Pierre-Benite
country: France
facility: Centre Hospitalier Lyo Sud, Service d'Hematologie et d'Oncologie
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strabourg - Hopital de Hautepierre
city: Frankfurt
country: Germany
facility: Staedtische Kliniken Hoechst
state: HE
city: Berlin
country: Germany
facility: Charite, Campus Benjamin Franklin
city: Hamburg
country: Germany
facility: Universitatklinik des Saarlandes, Innere Medzin I
city: Kaiserslautern
country: Germany
facility: Westpfalzklinikum Kaiserslautern
city: Koeln
country: Germany
facility: Klinikum der Universitaet zu Koeln
city: Moenchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH
city: Trier
country: Germany
facility: Mutterhaus der Borromaeerinne
city: Budapest
country: Hungary
facility: Szent Laszlo Korhaz
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Okato Korhaz
city: Gyula
country: Hungary
facility: Bekes Megyei Pandy Kalman Korhaz
city: Kaposvar
country: Hungary
facility: Kaposi Mor Megyei Korhaz
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvos-es Gyogy II
city: Hyderabaad
country: India
facility: Indo-American Cancer Institute & Research Center
state: AndhPrad
city: Panjagutta
country: India
facility: Nizam's Institute of Medical Sciences
state: Hyderabad
city: Bangalore
country: India
facility: Manipal Hospital
state: Karnataka
city: Manipala
country: India
facility: Shirdi Sai Baba Cancer Hospital, K.M.C. Manipal
state: Karna
city: Thiruvananthapuram
country: India
facility: Regional Cancer Center
state: Kerla
city: Jaipur
country: India
facility: Bhagwan Mahaveer Cancer Hospital & Research Center
state: Rajasthan
city: Bangalore
country: India
facility: M.S. Ramaiah Medical College
city: Mumbai
country: India
facility: Tata Memorial Hospital
city: Bologna
country: Italy
facility: Policlinico S. Orsola, Instituto di Ematologia
city: Cagliari
country: Italy
facility: Ospedale Oncologico "A. Businco"
city: Genova
country: Italy
facility: Ospedale S. Martino
city: Perugia
country: Italy
facility: Universita degli Studi Perugia Policlinico Monteluce
city: Pisa
country: Italy
facility: Azienda ospedaliera Pisana "Santa Chiara"
city: Pisa
country: Italy
facility: Azienda Ospedaliera Pisanan "Santana Chiara"
city: Rionero in Vulture
country: Italy
facility: Ospedale Oncolgoico Regionale della Basilicata
city: Roma
country: Italy
facility: Ospedale S. Eugenio
city: Roma
country: Italy
facility: Universita La Sapienza
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza
city: Siena
country: Italy
facility: Policlinico S. Maria alle Scotte
city: Taranto
country: Italy
facility: Presidio San Giuseppe Moscati
city: Udine
country: Italy
facility: Ospedale Civile
city: Medellin
country: Mexico
facility: Fundacion Centro De Investigacion
state: Columbia
city: Guatimala
country: Mexico
facility: Medical Solutions
state: Guatemala
city: Panama
country: Panama
facility: Complejo Hospitalario "Arnulfo Arias Madrid
city: Lima
country: Peru
facility: Hospital Edgardo Rebagliati Martins
city: San Borja
country: Peru
facility: Onococenter
city: Gdansk
country: Poland
facility: Klinika Hematologii, Onkologii i Chorob Wewnetrznych
city: Brasov
country: Romania
facility: Brasov Counthy Hospital
city: Bucharest
country: Romania
facility: Colentina Clinical Hospital Hem Dept
city: Bucharest
country: Romania
facility: Fundei Clinical Institute
city: Cluj Napoca
country: Romania
facility: Prof. Dr. Ian Chiricuta, Institute of Oncology, Radiotheraphy
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic "Ion Chiricuta" Oncologie Medicala
city: Targu Mures
country: Romania
facility: Mures County Clinical Hospital
city: Barnaul
country: Russian Federation
facility: State Medical Institution Altai Territorial Oncological Center
city: Bashkortostan
country: Russian Federation
facility: State Medical Institution Replubican Oncological Center
city: Chelyabinsk
country: Russian Federation
facility: State Therapeutical & Prophlatic Institution: Cheylabinsk Regional Oncological Center
city: Irkutsk
country: Russian Federation
facility: State Medical Institution
city: Krasnodar
country: Russian Federation
facility: State Medical Institution: Clinical Oncological Center
city: Moscow
country: Russian Federation
facility: Russian Oncological Research Center n.a. N.N. Blokhin
city: Moscow
country: Russian Federation
facility: State Institution: Hematological Research Center under the Russian Academy of Medical Sciences
city: Moscow
country: Russian Federation
facility: State Institution: Moscow Regional Research Clinical institute n.a. M.F.
city: Moscow
country: Russian Federation
facility: Semashko Central Clinical Hospital
city: Obninsk
country: Russian Federation
facility: Medical Radiological Research Center under the Russian academey of Medical Sciences
city: St. Petersburg
country: Russian Federation
facility: Research Insitute of Hematology and Blood Transfusion
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Pavlov State Medical Clinic of Intensive Care & Bone Marrow Transplantation
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Medical univ. n.a. I.P. Pavlov
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Medical Institution: Municipal Hospital #31
city: St. Petersburg
country: Russian Federation
facility: Central Research Rontgenological and Radiological Institute
city: St. Petersburg
country: Russian Federation
facility: State Research Institution: Research Institute of Oncology
city: Kyiv
country: Ukraine
facility: Institute of Clinical Radiology of the Research Center for Radiation Medicine under the UAMS
city: Kyiv
country: Ukraine
facility: Kyiv Bone Marrow Transplantation
city: Lviv
country: Ukraine
facility: Institute of Blood Pathology & Transfusion Medicine under the UAMS
city: Zhytomyr
country: Ukraine
facility: Zhtomyr O.F. Gerbachevsky Regional Hospital
city: Glasgow
country: United Kingdom
facility: Beatson Oncology Centre, Western Infirmary
city: London
country: United Kingdom
facility: St. Georges Hospital
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital
city: Montevideo
country: Uruguay
facility: Hospital Maciel
city: Poblado Montevideo Chico
country: Uruguay
facility: Hospital Policial de Montevideo
Study officials:
affiliation: Sr. Director, Clinical Operations
name: Simran Singh
role: STUDY_DIRECTOR
References:
citation: 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.