Lymphoma, Non-HodgkinPhase 3NCT00088530
BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
A Phase 3 study testing pixantrone, cyclophosphamide, vincristine, rituximab, prednisone and Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab in people with Lymphoma, Non-Hodgkin, run by CTI BioPharma at 99 sites in 20 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- pixantrone, cyclophosphamide, vincristine, rituximab, prednisone and Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 99 sitesin 20 countries
- Study dates
- Jul 2004to Jul 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
99 sites in 20 countries.
99 sites in 20 countries
Russia16 sites
State Medical Institution Altai Territorial Oncological Center
Barnaul, 656049
State Medical Institution Replubican Oncological Center
Bashkortostan, 450054
State Therapeutical & Prophlatic Institution: Cheylabinsk Regional Oncological Center
Chelyabinsk, 454087
State Medical Institution
Irkutsk, 664035
State Medical Institution: Clinical Oncological Center
Krasnodar, 350040
Russian Oncological Research Center n.a. N.N. Blokhin
Moscow, 115478
State Institution: Hematological Research Center under the Russian Academy of Medical Sciences
Moscow, 125167
State Institution: Moscow Regional Research Clinical institute n.a. M.F.
Moscow, 129110
Semashko Central Clinical Hospital
Moscow, 129128
Medical Radiological Research Center under the Russian academey of Medical Sciences
Obninsk, 249036
Research Insitute of Hematology and Blood Transfusion
Saint Petersburg, 191024
St. Petersburg Pavlov State Medical Clinic of Intensive Care & Bone Marrow Transplantation
Saint Petersburg, 197022
St. Petersburg State Medical univ. n.a. I.P. Pavlov
Saint Petersburg, 197022
St. Petersburg State Medical Institution: Municipal Hospital #31
Saint Petersburg, 197110
Central Research Rontgenological and Radiological Institute
Saint Petersburg, 197758
State Research Institution: Research Institute of Oncology
Saint Petersburg, 197758
Italy13 sites
Policlinico S. Orsola, Instituto di Ematologia
Bologna, 40138
Ospedale Oncologico "A. Businco"
Cagliari, 09100
Ospedale S. Martino
Genova, 16132
Universita degli Studi Perugia Policlinico Monteluce
Perugia, 06122
Azienda ospedaliera Pisana "Santa Chiara"
Pisa, 56126
Azienda Ospedaliera Pisanan "Santana Chiara"
Pisa, 56126
Ospedale Oncolgoico Regionale della Basilicata
Rionero in Vulture, 85028
Ospedale S. Eugenio
Roma, 00144
Universita La Sapienza
Roma, 00161
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
Policlinico S. Maria alle Scotte
Siena, 53100
Presidio San Giuseppe Moscati
Taranto, 74100
Ospedale Civile
Udine, 33100
United States9 sites
New Mexico Oncology/Hematology
Albuquerque, New Mexico, 87109
Rush University Medical Center
Chicago, Illinois, 60612
Duke University Medical Center
Durham, North Carolina, 27710
Robert A. Moss, M.D., FACP, Inc.
Fountain Valley, California, 92708
Watson Clinic for Cancer Care and Research
Lakeland, Florida, 33805
UCLA Medical Center
Los Angeles, California, 90095
Northern Utah Hematology Oncology, P.C.
Ogden, Utah, 84403
Northwest Kaiser Permanente
Portland, Oregon, 97227
SUNY Upstate Medical University
Syracuse, New York, 13210
Argentina8 sites
FUNDALEU - fundacion para combatir le Leucernia
Buenos Aires, 1114
Hospital Universitario Austral
Buenos Aires, B1629AHJ
Academia Nacional de Medicina
Caba, C1425AUM
Hospital Privado Centro Medico de Cordoba S.A.
Córdoba, X5016KEH
Clinica Modelo S.A.
Paraná, Entre Ríos Province, 3100
Instituto de Investigaciones Clinicas
Rosario, Santa Fe Province, 2000
Centro Oncologico Rosario
Rosario, Santa Fe Province, S2000DSK
ISIS Clinica Especializada
Santa Fe, S3000FFU
India8 sites
Manipal Hospital
Bangalore, Karnataka, 560017
M.S. Ramaiah Medical College
Bangalore, 560 054
Indo-American Cancer Institute & Research Center
Hyderabaad, AndhPrad, 500034
Bhagwan Mahaveer Cancer Hospital & Research Center
Jaipur, Rajasthan, 302017
Shirdi Sai Baba Cancer Hospital, K.M.C. Manipal
Manipal, Karna, 576119
Tata Memorial Hospital
Mumbai, 400012
Nizam's Institute of Medical Sciences
Panjagutta, Hyderabad, 500082
Regional Cancer Center
Thiruvananthapuram, Kerla, 695011
Germany7 sites
Charite, Campus Benjamin Franklin
Berlin, 12200
Klinikum der Universitaet zu Koeln
Cologne, 50924
Staedtische Kliniken Hoechst
Frankfurt am Main, Hesse, 65929
Universitatklinik des Saarlandes, Innere Medzin I
Hamburg, 66421
Westpfalzklinikum Kaiserslautern
Kaiserslautern, 67653
Kliniken Maria Hilf GmbH
Mönchengladbach, 41063
Mutterhaus der Borromaeerinne
Trier, 54290
Hungary6 sites
Szent Laszlo Korhaz
Budapest, H-1097
Petz Aladar Megyei Okato Korhaz
Győr, H-9024
Bekes Megyei Pandy Kalman Korhaz
Gyula, 5701
Kaposi Mor Megyei Korhaz
Kaposvár, H-7400
Pecsi Tudomanyegyetem
Pécs, H-7624
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvos-es Gyogy II
Szeged, 6701
Romania6 sites
Brasov Counthy Hospital
Brasov, 500326
Colentina Clinical Hospital Hem Dept
Bucharest, 020125
Fundei Clinical Institute
Bucharest, 022328
Institutul Oncologic "Ion Chiricuta" Oncologie Medicala
Cluj-Napoca, 400015
Prof. Dr. Ian Chiricuta, Institute of Oncology, Radiotheraphy
Cluj-Napoca, 400015
Mures County Clinical Hospital
Târgu Mureş, 540136
Ukraine4 sites
Institute of Clinical Radiology of the Research Center for Radiation Medicine under the UAMS
Kyiv, 03115
Kyiv Bone Marrow Transplantation
Kyiv, 03115
Institute of Blood Pathology & Transfusion Medicine under the UAMS
Lviv, 79044
Zhtomyr O.F. Gerbachevsky Regional Hospital
Zhytomyr, 10002
Bulgaria3 sites
University Gernal Hospital for Active Treatment "Alexandrovska" - Clinic of Hematology
Sofia, 1431
National Centre for Hemotransfusion
Sofia, 1756
University General Hospital for Active Treatment "St. Marina" Clinic of Hematology
Varna, 9000
Ecuador3 sites
Hospital Oncologico de Solca
Capilla Mauta, Guayaquil, 3623
Hospital Carlos Andrade Marin Oncologia
Quito, Pinchincha, 17
Hospital Solca Quito
Quito
France3 sites
Institute Bergonie
Bordeaux, 33076
Centre Hospitalier Lyo Sud, Service d'Hematologie et d'Oncologie
Pierre-Bénite, 69310
Hopitaux Universitaires de Strabourg - Hopital de Hautepierre
Strasbourg, 67200
United Kingdom3 sites
Beatson Oncology Centre, Western Infirmary
Glasgow, G11 6T
St. Georges Hospital
London, SW17 0QT
Weston Park Hospital
Sheffield, S10 2Sj
Mexico2 sites
Medical Solutions
Guatemala, Guatemala
Fundacion Centro De Investigacion
Medellín, Columbia
Uruguay2 sites
Hospital Maciel
Montevideo, 11000
Hospital Policial de Montevideo
Poblado Montevideo Chico, 12000
Estonia1 site
Tartu University Clinics, Hematology Oncology Clinic
Tartu, 51014
Poland1 site
Klinika Hematologii, Onkologii i Chorob Wewnetrznych
Gdansk, 80-211
About this study
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
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).
Read the 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.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- pixantrone, cyclophosphamide, vincristine, rituximab, prednisone, Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab
- Keywords
- Pixantrone, Non-Hodgkins lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pixantrone, cyclophosphamide, vincristine, rituximab, prednisoneDrug
Also called BBR2778
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 RituximabDrug
Day 1: cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Pixantrone (BBR2778) Receives: Drug: pixantrone, cyclophosphamide, vincristine, rituximab, prednisone |
| Comparator Arm | Active comparator | To be chosen by the investigator, among vinorelbine, oxaliplatin, ifosfamide, etoposide or mitoxantrone Receives: Drug: Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: EOT; approximately 6 months
Secondary outcomes (3)
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.
Measured: 18 months after 6 cycles of treatment; approximately 24 months
Overall Survival
The time between the date of randomization and the date of death due to any cause.
Measured: 18 months after 6 cycles of treatment; approximately 24 months
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.
Measured: approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2004 (estimated)
- Study startJul 2004
- Primary completionFeb 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- CTI BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simran Singh, Study director, Sr. Director, Clinical Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088530
- Sponsor's protocol ID
- PIX301
- Status last verified
- Jan 2020
- First submitted
- 28 Jul 2004
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22652183
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00088530
- Acronym / sponsor ID
- PIX301
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- Pixantrone, Non-Hodgkins lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- CTI BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 29 Jul 2004 (estimated)
- Results
- Posted 1 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: pixantrone, cyclophosphamide, vincristine, rituximab, prednisonePixantrone (BBR2778) |
| Comparator Arm | Active comparator | Drug: Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or RituximabTo be chosen by the investigator, among vinorelbine, oxaliplatin, ifosfamide, etoposide or mitoxantrone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pixantrone, cyclophosphamide, vincristine, rituximab, prednisoneAlso: BBR2778Day 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) | Drug | Experimental Arm |
| Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or RituximabDay 1: cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day) | Drug | Comparator Arm |
Primary outcome
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)
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 18 months after 6 cycles of treatment; approximately 24 months
Overall Survival
Time frame: 18 months after 6 cycles of treatment; approximately 24 months
Overall Response Rate (ORR) Lasting at Least 4 Months
Time frame: approximately 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22652183Pettengell 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.
- CTI company websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simran Singh study director
Sr. Director, Clinical Operations
99 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pixantrone, cyclophosphamide, vincristine, rituximab, prednisone and Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab in people with Lymphoma, Non-Hodgkin, run by CTI BioPharma at 99 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 99 sites in Russia, Italy, United States, Argentina, India and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) and Complete Response Unconfirmed (CRu) (time frame: EOT; approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00088530, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.