Back to resultsBBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
Primary Purpose
Lymphoma, Non-Hodgkin
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pixantrone, cyclophosphamide, vincristine, rituximab, prednisone
Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Pixantrone, Non-Hodgkins lymphoma
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
Sites / Locations
- Robert A. Moss, M.D., FACP, Inc.
- UCLA Medical Center
- Watson Clinic for Cancer Care and Research
- Rush University Medical Center
- New Mexico Oncology/Hematology
- SUNY Upstate Medical University
- Duke University Medical Center
- Northwest Kaiser Permanente
- Northern Utah Hematology Oncology, P.C.
- Clinica Modelo S.A.
- Instituto de Investigaciones Clinicas
- Centro Oncologico Rosario
- FUNDALEU - fundacion para combatir le Leucernia
- Hospital Universitario Austral
- Academia Nacional de Medicina
- Hospital Privado Centro Medico de Cordoba S.A.
- ISIS Clinica Especializada
- University Gernal Hospital for Active Treatment "Alexandrovska" - Clinic of Hematology
- National Centre for Hemotransfusion
- University General Hospital for Active Treatment "St. Marina" Clinic of Hematology
- Hospital CIMA San Jose
- Hospital Oncologico de Solca
- Hospital Carlos Andrade Marin Oncologia
- Hospital Solca Quito
- Tartu University Clinics, Hematology Oncology Clinic
- Institute Bergonie
- Centre Hospitalier Lyo Sud, Service d'Hematologie et d'Oncologie
- Hopitaux Universitaires de Strabourg - Hopital de Hautepierre
- Staedtische Kliniken Hoechst
- Charite, Campus Benjamin Franklin
- Universitatklinik des Saarlandes, Innere Medzin I
- Westpfalzklinikum Kaiserslautern
- Klinikum der Universitaet zu Koeln
- Kliniken Maria Hilf GmbH
- Mutterhaus der Borromaeerinne
- Szent Laszlo Korhaz
- Petz Aladar Megyei Okato Korhaz
- Bekes Megyei Pandy Kalman Korhaz
- Kaposi Mor Megyei Korhaz
- Pecsi Tudomanyegyetem
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvos-es Gyogy II
- Indo-American Cancer Institute & Research Center
- Nizam's Institute of Medical Sciences
- Manipal Hospital
- Shirdi Sai Baba Cancer Hospital, K.M.C. Manipal
- Regional Cancer Center
- Bhagwan Mahaveer Cancer Hospital & Research Center
- M.S. Ramaiah Medical College
- Tata Memorial Hospital
- Policlinico S. Orsola, Instituto di Ematologia
- Ospedale Oncologico "A. Businco"
- Ospedale S. Martino
- Universita degli Studi Perugia Policlinico Monteluce
- Azienda ospedaliera Pisana "Santa Chiara"
- Azienda Ospedaliera Pisanan "Santana Chiara"
- Ospedale Oncolgoico Regionale della Basilicata
- Ospedale S. Eugenio
- Universita La Sapienza
- Ospedale Casa Sollievo della Sofferenza
- Policlinico S. Maria alle Scotte
- Presidio San Giuseppe Moscati
- Ospedale Civile
- Fundacion Centro De Investigacion
- Medical Solutions
- Complejo Hospitalario "Arnulfo Arias Madrid
- Hospital Edgardo Rebagliati Martins
- Onococenter
- Klinika Hematologii, Onkologii i Chorob Wewnetrznych
- Brasov Counthy Hospital
- Colentina Clinical Hospital Hem Dept
- Fundei Clinical Institute
- Prof. Dr. Ian Chiricuta, Institute of Oncology, Radiotheraphy
- Institutul Oncologic "Ion Chiricuta" Oncologie Medicala
- Mures County Clinical Hospital
- State Medical Institution Altai Territorial Oncological Center
- State Medical Institution Replubican Oncological Center
- State Therapeutical & Prophlatic Institution: Cheylabinsk Regional Oncological Center
- State Medical Institution
- State Medical Institution: Clinical Oncological Center
- Russian Oncological Research Center n.a. N.N. Blokhin
- State Institution: Hematological Research Center under the Russian Academy of Medical Sciences
- State Institution: Moscow Regional Research Clinical institute n.a. M.F.
- Semashko Central Clinical Hospital
- Medical Radiological Research Center under the Russian academey of Medical Sciences
- Research Insitute of Hematology and Blood Transfusion
- St. Petersburg Pavlov State Medical Clinic of Intensive Care & Bone Marrow Transplantation
- St. Petersburg State Medical univ. n.a. I.P. Pavlov
- St. Petersburg State Medical Institution: Municipal Hospital #31
- Central Research Rontgenological and Radiological Institute
- State Research Institution: Research Institute of Oncology
- Institute of Clinical Radiology of the Research Center for Radiation Medicine under the UAMS
- Kyiv Bone Marrow Transplantation
- Institute of Blood Pathology & Transfusion Medicine under the UAMS
- Zhtomyr O.F. Gerbachevsky Regional Hospital
- Beatson Oncology Centre, Western Infirmary
- St. Georges Hospital
- Weston Park Hospital
- Hospital Maciel
- Hospital Policial de Montevideo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Arm
Comparator Arm
Arm Description
Pixantrone (BBR2778)
To be chosen by the investigator, among vinorelbine, oxaliplatin, ifosfamide, etoposide or mitoxantrone
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Overall Survival
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00088530
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CTI BioPharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
Keywords
Pixantrone, Non-Hodgkins lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
Pixantrone (BBR2778)
Arm Title
Comparator Arm
Arm Type
Active Comparator
Arm Description
To be chosen by the investigator, among vinorelbine, oxaliplatin, ifosfamide, etoposide or mitoxantrone
Intervention Type
Drug
Intervention Name(s)
pixantrone, cyclophosphamide, vincristine, rituximab, prednisone
Other Intervention Name(s)
BBR2778
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab
Intervention Description
Day 1: cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)
Primary Outcome Measure Information:
Title
Complete Response (CR) and Complete Response Unconfirmed (CRu)
Description
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)
Time Frame
EOT; approximately 6 months
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
The time between the date of randomization and the date of the initial documentation of progressive/relapsed disease or death due to any cause.
Time Frame
18 months after 6 cycles of treatment; approximately 24 months
Title
Overall Survival
Description
The time between the date of randomization and the date of death due to any cause.
Time Frame
18 months after 6 cycles of treatment; approximately 24 months
Title
Overall Response Rate (ORR) Lasting at Least 4 Months
Description
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.
Time Frame
approximately 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simran Singh
Organizational Affiliation
Sr. Director, Clinical Operations
Official's Role
Study Director
Facility Information:
Facility Name
Robert A. Moss, M.D., FACP, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Watson Clinic for Cancer Care and Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
New Mexico Oncology/Hematology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Northwest Kaiser Permanente
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Northern Utah Hematology Oncology, P.C.
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Clinica Modelo S.A.
City
Parana
State/Province
Entre Rios
ZIP/Postal Code
3100
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Centro Oncologico Rosario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSK
Country
Argentina
Facility Name
FUNDALEU - fundacion para combatir le Leucernia
City
Buenos Aires
ZIP/Postal Code
1114
Country
Argentina
Facility Name
Hospital Universitario Austral
City
Buenos Aires
ZIP/Postal Code
B1629AHJ
Country
Argentina
Facility Name
Academia Nacional de Medicina
City
Caba
ZIP/Postal Code
C1425AUM
Country
Argentina
Facility Name
Hospital Privado Centro Medico de Cordoba S.A.
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
ISIS Clinica Especializada
City
Santa Fe
ZIP/Postal Code
S3000FFU
Country
Argentina
Facility Name
University Gernal Hospital for Active Treatment "Alexandrovska" - Clinic of Hematology
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
National Centre for Hemotransfusion
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
University General Hospital for Active Treatment "St. Marina" Clinic of Hematology
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Hospital CIMA San Jose
City
Escazu
Country
Costa Rica
Facility Name
Hospital Oncologico de Solca
City
Capilla Mauta
State/Province
Guayaquil
ZIP/Postal Code
3623
Country
Ecuador
Facility Name
Hospital Carlos Andrade Marin Oncologia
City
Quito,
State/Province
Pinchincha
ZIP/Postal Code
17
Country
Ecuador
Facility Name
Hospital Solca Quito
City
Quito
Country
Ecuador
Facility Name
Tartu University Clinics, Hematology Oncology Clinic
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Institute Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Hospitalier Lyo Sud, Service d'Hematologie et d'Oncologie
City
Pierre-Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Hopitaux Universitaires de Strabourg - Hopital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Staedtische Kliniken Hoechst
City
Frankfurt
State/Province
HE
ZIP/Postal Code
65929
Country
Germany
Facility Name
Charite, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Universitatklinik des Saarlandes, Innere Medzin I
City
Hamburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Westpfalzklinikum Kaiserslautern
City
Kaiserslautern
ZIP/Postal Code
67653
Country
Germany
Facility Name
Klinikum der Universitaet zu Koeln
City
Koeln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Kliniken Maria Hilf GmbH
City
Moenchengladbach
ZIP/Postal Code
41063
Country
Germany
Facility Name
Mutterhaus der Borromaeerinne
City
Trier
ZIP/Postal Code
54290
Country
Germany
Facility Name
Szent Laszlo Korhaz
City
Budapest
ZIP/Postal Code
H-1097
Country
Hungary
Facility Name
Petz Aladar Megyei Okato Korhaz
City
Gyor
ZIP/Postal Code
H-9024
Country
Hungary
Facility Name
Bekes Megyei Pandy Kalman Korhaz
City
Gyula
ZIP/Postal Code
5701
Country
Hungary
Facility Name
Kaposi Mor Megyei Korhaz
City
Kaposvar
ZIP/Postal Code
H-7400
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem
City
Pecs
ZIP/Postal Code
H-7624
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvos-es Gyogy II
City
Szeged
ZIP/Postal Code
6701
Country
Hungary
Facility Name
Indo-American Cancer Institute & Research Center
City
Hyderabaad
State/Province
AndhPrad
ZIP/Postal Code
500034
Country
India
Facility Name
Nizam's Institute of Medical Sciences
City
Panjagutta
State/Province
Hyderabad
ZIP/Postal Code
500082
Country
India
Facility Name
Manipal Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560017
Country
India
Facility Name
Shirdi Sai Baba Cancer Hospital, K.M.C. Manipal
City
Manipala
State/Province
Karna
ZIP/Postal Code
576119
Country
India
Facility Name
Regional Cancer Center
City
Thiruvananthapuram
State/Province
Kerla
ZIP/Postal Code
695011
Country
India
Facility Name
Bhagwan Mahaveer Cancer Hospital & Research Center
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Facility Name
M.S. Ramaiah Medical College
City
Bangalore
ZIP/Postal Code
560 054
Country
India
Facility Name
Tata Memorial Hospital
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
Policlinico S. Orsola, Instituto di Ematologia
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ospedale Oncologico "A. Businco"
City
Cagliari
ZIP/Postal Code
09100
Country
Italy
Facility Name
Ospedale S. Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Universita degli Studi Perugia Policlinico Monteluce
City
Perugia
ZIP/Postal Code
06122
Country
Italy
Facility Name
Azienda ospedaliera Pisana "Santa Chiara"
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Azienda Ospedaliera Pisanan "Santana Chiara"
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Ospedale Oncolgoico Regionale della Basilicata
City
Rionero in Vulture
ZIP/Postal Code
85028
Country
Italy
Facility Name
Ospedale S. Eugenio
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Universita La Sapienza
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
Country
Italy
Facility Name
Policlinico S. Maria alle Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Presidio San Giuseppe Moscati
City
Taranto
ZIP/Postal Code
74100
Country
Italy
Facility Name
Ospedale Civile
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Fundacion Centro De Investigacion
City
Medellin
State/Province
Columbia
Country
Mexico
Facility Name
Medical Solutions
City
Guatimala
State/Province
Guatemala
Country
Mexico
Facility Name
Complejo Hospitalario "Arnulfo Arias Madrid
City
Panama
Country
Panama
Facility Name
Hospital Edgardo Rebagliati Martins
City
Lima
ZIP/Postal Code
11
Country
Peru
Facility Name
Onococenter
City
San Borja
Country
Peru
Facility Name
Klinika Hematologii, Onkologii i Chorob Wewnetrznych
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Brasov Counthy Hospital
City
Brasov
ZIP/Postal Code
500326
Country
Romania
Facility Name
Colentina Clinical Hospital Hem Dept
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
Fundei Clinical Institute
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Prof. Dr. Ian Chiricuta, Institute of Oncology, Radiotheraphy
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Institutul Oncologic "Ion Chiricuta" Oncologie Medicala
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Mures County Clinical Hospital
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
State Medical Institution Altai Territorial Oncological Center
City
Barnaul
ZIP/Postal Code
656049
Country
Russian Federation
Facility Name
State Medical Institution Replubican Oncological Center
City
Bashkortostan
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
State Therapeutical & Prophlatic Institution: Cheylabinsk Regional Oncological Center
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
State Medical Institution
City
Irkutsk
ZIP/Postal Code
664035
Country
Russian Federation
Facility Name
State Medical Institution: Clinical Oncological Center
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Russian Oncological Research Center n.a. N.N. Blokhin
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
State Institution: Hematological Research Center under the Russian Academy of Medical Sciences
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
State Institution: Moscow Regional Research Clinical institute n.a. M.F.
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
Semashko Central Clinical Hospital
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Medical Radiological Research Center under the Russian academey of Medical Sciences
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Research Insitute of Hematology and Blood Transfusion
City
St. Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
St. Petersburg Pavlov State Medical Clinic of Intensive Care & Bone Marrow Transplantation
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
St. Petersburg State Medical univ. n.a. I.P. Pavlov
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
St. Petersburg State Medical Institution: Municipal Hospital #31
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Central Research Rontgenological and Radiological Institute
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
State Research Institution: Research Institute of Oncology
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Institute of Clinical Radiology of the Research Center for Radiation Medicine under the UAMS
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Kyiv Bone Marrow Transplantation
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Institute of Blood Pathology & Transfusion Medicine under the UAMS
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Zhtomyr O.F. Gerbachevsky Regional Hospital
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine
Facility Name
Beatson Oncology Centre, Western Infirmary
City
Glasgow
ZIP/Postal Code
G11 6T
Country
United Kingdom
Facility Name
St. Georges Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
ZIP/Postal Code
S10 2Sj
Country
United Kingdom
Facility Name
Hospital Maciel
City
Montevideo
ZIP/Postal Code
11000
Country
Uruguay
Facility Name
Hospital Policial de Montevideo
City
Poblado Montevideo Chico
ZIP/Postal Code
12000
Country
Uruguay
12. IPD Sharing Statement
Citations:
PubMed Identifier
22652183
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. Erratum In: Lancet Oncol. 2012 Jul;13(7):e285.
Results Reference
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BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
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