BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
- Conditions
- Lymphoma, Non-Hodgkin
- Interventions
- Drug: pixantrone, cyclophosphamide, vincristine, rituximab, prednisoneDrug: Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab
- Registration Number
- NCT00088530
- Lead Sponsor
- CTI BioPharma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Arm pixantrone, cyclophosphamide, vincristine, rituximab, prednisone Pixantrone (BBR2778) Comparator Arm Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab To be chosen by the investigator, among vinorelbine, oxaliplatin, ifosfamide, etoposide or mitoxantrone
- Primary Outcome Measures
Name Time Method Complete Response (CR) and Complete Response Unconfirmed (CRu) 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)
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS) 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.
Overall Survival 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.
Overall Response Rate (ORR) Lasting at Least 4 Months 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.
Trial Locations
- Locations (99)
Hospital Solca Quito
🇪🇨Quito, Ecuador
Institute Bergonie
🇫🇷Bordeaux, France
Charite, Campus Benjamin Franklin
🇩🇪Berlin, Germany
FUNDALEU - fundacion para combatir le Leucernia
🇦🇷Buenos Aires, Argentina
State Institution: Hematological Research Center under the Russian Academy of Medical Sciences
🇷🇺Moscow, Russian Federation
State Medical Institution
🇷🇺Irkutsk, Russian Federation
Staedtische Kliniken Hoechst
🇩🇪Frankfurt, HE, Germany
Bekes Megyei Pandy Kalman Korhaz
🇭🇺Gyula, Hungary
Ospedale Oncologico "A. Businco"
🇮🇹Cagliari, Italy
Kliniken Maria Hilf GmbH
🇩🇪Moenchengladbach, Germany
Institute of Clinical Radiology of the Research Center for Radiation Medicine under the UAMS
🇺🇦Kyiv, Ukraine
Clinica Modelo S.A.
🇦🇷Parana, Entre Rios, Argentina
State Medical Institution: Clinical Oncological Center
🇷🇺Krasnodar, Russian Federation
Centre Hospitalier Lyo Sud, Service d'Hematologie et d'Oncologie
🇫🇷Pierre-Benite, France
State Medical Institution Altai Territorial Oncological Center
🇷🇺Barnaul, Russian Federation
Ospedale S. Eugenio
🇮🇹Roma, Italy
Colentina Clinical Hospital Hem Dept
🇷🇴Bucharest, Romania
Prof. Dr. Ian Chiricuta, Institute of Oncology, Radiotheraphy
🇷🇴Cluj Napoca, Romania
State Research Institution: Research Institute of Oncology
🇷🇺St. Petersburg, Russian Federation
Weston Park Hospital
🇬🇧Sheffield, United Kingdom
Zhtomyr O.F. Gerbachevsky Regional Hospital
🇺🇦Zhytomyr, Ukraine
Medical Radiological Research Center under the Russian academey of Medical Sciences
🇷🇺Obninsk, Russian Federation
Petz Aladar Megyei Okato Korhaz
🇭🇺Gyor, Hungary
Azienda ospedaliera Pisana "Santa Chiara"
🇮🇹Pisa, Italy
St. Petersburg State Medical univ. n.a. I.P. Pavlov
🇷🇺St. Petersburg, Russian Federation
State Medical Institution Replubican Oncological Center
🇷🇺Bashkortostan, Russian Federation
Indo-American Cancer Institute & Research Center
🇮🇳Hyderabaad, AndhPrad, India
Fundei Clinical Institute
🇷🇴Bucharest, Romania
Klinika Hematologii, Onkologii i Chorob Wewnetrznych
🇵🇱Gdansk, Poland
Kyiv Bone Marrow Transplantation
🇺🇦Kyiv, Ukraine
Russian Oncological Research Center n.a. N.N. Blokhin
🇷🇺Moscow, Russian Federation
Universita La Sapienza
🇮🇹Roma, Italy
Hospital Maciel
🇺🇾Montevideo, Uruguay
Policlinico S. Maria alle Scotte
🇮🇹Siena, Italy
Hospital Carlos Andrade Marin Oncologia
🇪🇨Quito,, Pinchincha, Ecuador
Institutul Oncologic "Ion Chiricuta" Oncologie Medicala
🇷🇴Cluj-Napoca, Romania
Tartu University Clinics, Hematology Oncology Clinic
🇪🇪Tartu, Estonia
Medical Solutions
🇲🇽Guatimala, Guatemala, Mexico
Hospital Policial de Montevideo
🇺🇾Poblado Montevideo Chico, Uruguay
Shirdi Sai Baba Cancer Hospital, K.M.C. Manipal
🇮🇳Manipala, Karna, India
Tata Memorial Hospital
🇮🇳Mumbai, India
Complejo Hospitalario "Arnulfo Arias Madrid
🇵🇦Panama, Panama
Hospital Edgardo Rebagliati Martins
🇵🇪Lima, Peru
Onococenter
🇵🇪San Borja, Peru
Brasov Counthy Hospital
🇷🇴Brasov, Romania
Mures County Clinical Hospital
🇷🇴Targu Mures, Romania
St. Georges Hospital
🇬🇧London, United Kingdom
Research Insitute of Hematology and Blood Transfusion
🇷🇺St. Petersburg, Russian Federation
St. Petersburg State Medical Institution: Municipal Hospital #31
🇷🇺St. Petersburg, Russian Federation
Robert A. Moss, M.D., FACP, Inc.
🇺🇸Fountain Valley, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Northwest Kaiser Permanente
🇺🇸Portland, Oregon, United States
Northern Utah Hematology Oncology, P.C.
🇺🇸Ogden, Utah, United States
Bhagwan Mahaveer Cancer Hospital & Research Center
🇮🇳Jaipur, Rajasthan, India
Ospedale Civile
🇮🇹Udine, Italy
New Mexico Oncology/Hematology
🇺🇸Albuquerque, New Mexico, United States
Instituto de Investigaciones Clinicas
🇦🇷Rosario, Santa Fe, Argentina
Watson Clinic for Cancer Care and Research
🇺🇸Lakeland, Florida, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Centro Oncologico Rosario
🇦🇷Rosario, Santa Fe, Argentina
Academia Nacional de Medicina
🇦🇷Caba, Argentina
National Centre for Hemotransfusion
🇧🇬Sofia, Bulgaria
Hospital Privado Centro Medico de Cordoba S.A.
🇦🇷Cordoba, Argentina
Hospital Universitario Austral
🇦🇷Buenos Aires, Argentina
University General Hospital for Active Treatment "St. Marina" Clinic of Hematology
🇧🇬Varna, Bulgaria
ISIS Clinica Especializada
🇦🇷Santa Fe, Argentina
University Gernal Hospital for Active Treatment "Alexandrovska" - Clinic of Hematology
🇧🇬Sofia, Bulgaria
Hospital CIMA San Jose
🇨🇷Escazu, Costa Rica
Hospital Oncologico de Solca
🇪🇨Capilla Mauta, Guayaquil, Ecuador
Hopitaux Universitaires de Strabourg - Hopital de Hautepierre
🇫🇷Strasbourg, France
Universitatklinik des Saarlandes, Innere Medzin I
🇩🇪Hamburg, Germany
Westpfalzklinikum Kaiserslautern
🇩🇪Kaiserslautern, Germany
Klinikum der Universitaet zu Koeln
🇩🇪Koeln, Germany
Mutterhaus der Borromaeerinne
🇩🇪Trier, Germany
Szent Laszlo Korhaz
🇭🇺Budapest, Hungary
Kaposi Mor Megyei Korhaz
🇭🇺Kaposvar, Hungary
Regional Cancer Center
🇮🇳Thiruvananthapuram, Kerla, India
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvos-es Gyogy II
🇭🇺Szeged, Hungary
Nizam's Institute of Medical Sciences
🇮🇳Panjagutta, Hyderabad, India
Pecsi Tudomanyegyetem
🇭🇺Pecs, Hungary
Manipal Hospital
🇮🇳Bangalore, Karnataka, India
M.S. Ramaiah Medical College
🇮🇳Bangalore, India
Policlinico S. Orsola, Instituto di Ematologia
🇮🇹Bologna, Italy
Ospedale S. Martino
🇮🇹Genova, Italy
Universita degli Studi Perugia Policlinico Monteluce
🇮🇹Perugia, Italy
Azienda Ospedaliera Pisanan "Santana Chiara"
🇮🇹Pisa, Italy
Ospedale Oncolgoico Regionale della Basilicata
🇮🇹Rionero in Vulture, Italy
Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
Presidio San Giuseppe Moscati
🇮🇹Taranto, Italy
Fundacion Centro De Investigacion
🇲🇽Medellin, Columbia, Mexico
State Therapeutical & Prophlatic Institution: Cheylabinsk Regional Oncological Center
🇷🇺Chelyabinsk, Russian Federation
St. Petersburg Pavlov State Medical Clinic of Intensive Care & Bone Marrow Transplantation
🇷🇺St. Petersburg, Russian Federation
Semashko Central Clinical Hospital
🇷🇺Moscow, Russian Federation
Beatson Oncology Centre, Western Infirmary
🇬🇧Glasgow, United Kingdom
Central Research Rontgenological and Radiological Institute
🇷🇺St. Petersburg, Russian Federation
Institute of Blood Pathology & Transfusion Medicine under the UAMS
🇺🇦Lviv, Ukraine
State Institution: Moscow Regional Research Clinical institute n.a. M.F.
🇷🇺Moscow, Russian Federation