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

Lymphoma, Non-Hodgkin Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00088530
• Other study ID #: PIX301
• Status: Completed
• Phase: Phase 3
• Start date: July 2004
• Est. completion date: July 2010

Study information

• Verified date: January 2020
• Source: CTI BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Other known NCT identifiers

• NCT00101049

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

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)
• 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)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
CTI BioPharma

Countries where clinical trial is conducted

United States,  Uruguay,  Argentina,  Bulgaria,  Costa Rica,  Ecuador,  Estonia,  France,  Germany,  Hungary,  India,  Italy,  Mexico,  Panama,  Peru,  Poland,  Romania,  Russian Federation,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-Free Survival (PFS)	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
Secondary	Overall Survival	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
Secondary	Overall Response Rate (ORR) Lasting at Least 4 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

External Links

•   CTI company website