AzTrials
AzTrials

Diffuse Large B-cell LymphomaPhase 3PIX-RNCT01321541

Comparison of Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma or Follicular Grade 3 Lymphoma Who Have Relapsed After Therapy and Are Not Eligible for Stem Cell Transplant

A Phase 3 study testing Pixantrone + Rituximab and Gemcitabine + Rituximab in people with Diffuse Large B-cell Lymphoma and de Novo DLBCL, run by CTI BioPharma at 131 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), or follicular grade 3 lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pixantrone + Rituximab and Gemcitabine + Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
312 participants
Where
131 sitesin 17 countries
Study dates
20 Apr 2011to 14 Sep 2018
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

  • Diagnosis of DLBCL (de novo DLBCL, or transformed from indolent lymphoma) or follicular grade 3 lymphoma on the basis of tissue biopsy.
  • Patients with de novo DLBCL must have received 1-3 treatment regimens for DLBCL. Patients with follicular grade 3 lymphoma must have received 1-3 treatment regimens for follicular lymphoma (any grade). Patients with DLBCL transformed from indolent lymphoma must have received at least 1-4 treatment regimens for NHL.
  • Received rituximab containing a multi-agent therapy for the treatment of NHL.
  • Not eligible for high-dose chemotherapy and stem cell transplant.
  • Patients with DLBCL transformed from indolent lymphoma must have had a complete or partial response to a therapy for NHL lasting at least 12 weeks.

Who cannot join

  • Primary refractory de novo DLBCL or primary refractory follicular grade 3 lymphoma, defined as documented progression within 12 weeks of the last cycle of the first-line multi-agent regimen.
  • Prior treatment with cumulative dose of doxorubicin or equivalent exceeding 450 mg/m2
  • Any experimental therapy ≤ 28 days prior to randomization
  • Other malignancy within last 5 years except for the following: curatively treated basal cell/squamous cell skin cancer, carcinoma in situ of the cervix, superficial transitional cell bladder carcinoma, or in situ ductal carcinoma of the breast after complete resection
  • Any contraindication or known allergy or hypersensitivity to any study drugs
  • Concomitant therapy with any anticancer agents, immunosuppressive agents, other investigational anticancer therapies. Low-dose corticosteroids for the treatment of non cancer-related illnesses are permitted.

Trial locations and contacts

131 sites in 17 countries.

131 sites in 17 countries

United States51 sites

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • Harry and Jeanette Weinberg Cancer Institute at Franklin Square

    Baltimore, Maryland, 21237

  • Highlands Oncology Group

    Bentonville, Arkansas, 72712

  • Center for Cancer and Blood Disorders, PC

    Bethesda, Maryland, 20817

  • Rocky Mountain Cancer Centers

    Boulder, Colorado, 80303

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Carle Physician Group

    Danville, Illinois, 61832

  • Cancer Care Specialists of Central Illinois

    Decatur, Illinois, 62526

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Gabrail Cancer Center

    Dover, Ohio, 44622

  • North Shore Hematology/Oncology Associates

    East Setauket, New York, 11733

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Metro Minnesota CCOP-Unity Hospital

    Fridley, Minnesota, 55432

  • Cancer & Hematology Center of Western Michigan

    Grand Rapids, Michigan, 49450

  • Saint Vincent Hospital Green Bay Oncology

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology-St. Mary's Hospital MC

    Green Bay, Wisconsin, 54303

  • Upstate Oncology Associates

    Greenville, South Carolina, 29615

  • South Carolina Cancer Specialists

    Hardeeville, South Carolina, 29927

  • South Carolina Cancer Specialists

    Hilton Head Island, South Carolina, 29926

  • Integrated Community Oncology Network-St. Vincent's

    Jacksonville, Florida, 32204

  • Integrated Community Oncology Network-Southside

    Jacksonville, Florida, 32207

  • Nebraska Hematology-Oncology, PC

    Lincoln, Nebraska, 68506

  • Baptist Hospital East

    Louisville, Kentucky, 40207

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410

  • Metro Minnesota CCOP-St. Johns

    Maplewood, Minnesota, 55109

  • Carle Foundation Physician Services

    Mattoon, Illinois, 61938

  • Hematology-Oncology Associates of Northern New Jersey

    Morristown, New Jersey, 07962

  • Cancer Care Centers of South Texas-HOAST

    New Braunfels, Texas, 78130

  • Integrated Community Oncology Network

    Orange Park, Florida, 32073

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Northwest Cancer Specialists, PC

    Portland, Oregon, 97213

  • Northwest Cancer Specialists, PC

    Portland, Oregon, 97225

  • Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

  • Metro Minnesota Community Clinical Oncology Program

    Saint Louis Park, Minnesota, 55416

  • Metro Minnesota Community Clinical Oncology Program

    Saint Louis Park, Minnesota, 55426

  • Metro Minnesota CCOP-Regions Hospital

    Saint Paul, Minnesota, 55101

  • Cancer Care Centers of South Texas-HOAST

    San Antonio, Texas, 78229

  • Toledo Clinical Cancer Center

    Toledo, Ohio, 43617

  • Mercy Cancer Center at St. Anne's

    Toledo, Ohio, 43623

  • Toledo Clinic Cancer Center-Toledo

    Toledo, Ohio, 43623

  • Northwest Cancer Specialists, PC

    Tualatin, Oregon, 97062

  • Arizona Clinical Research Center

    Tucson, Arizona, 85715

  • Arizona Oncology Associates

    Tucson, Arizona, 85745

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Northwest Cancer Specialists, PC

    Vancouver, Washington, 98684

  • Northwest Cancer Specialists, PC

    Vancouver, Washington, 98686

  • George Washington University Department of Medicine

    Washington D.C., District of Columbia, 20037

  • Cancer Center of Kansas

    Wichita, Kansas, 67208

  • Cancer Center of Kansas

    Wichita, Kansas, 67215

Other trials in United States

Italy9 sites

  • University Hospital "Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi"

    Ancona, 70126

  • Bologna University Hospital Authority St. Orsola-Malpighi Polyclinic

    Bologna, 40138

  • Scientific Institute of Romagna for the Study and Treatment of Cancer (I.R.S.T.) S.R.L.

    Meldola, 47014

  • "Ospedali Riuniti Villa Sofia-Cervello" Hospital

    Palermo, 90146

  • Romagna Local Health Authority (AUSL Romagna) - "Santa Maria delle Croci"

    Ravenna, 48121

  • Romagna Local Health Authority (AUSL Romagna) - "Infermi" Hospital

    Rimini, 47900

  • Siena University Hospital Authority Santa Maria alle Scotte Polyclinic

    Siena, 53100

  • Santa Maria Hospital

    Terni, 5100

  • A.O.U. Città della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

France8 sites

  • Service d'hématologie clinique, Avenue Laennec Salouel

    Amiens, 80054

  • Centre hopitalier de la cote basque

    Bayonne, 64190

  • Centre hospitalier de Beziers

    Béziers, 34500

  • Polyclinique de Bordeaux nord Acquitaine

    Bordeaux, 33077

  • Centre hospitalier du Mans

    Le Mans, 72037

  • Centre hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Saint Quentin Hospital Center, Department of Oncology-Hematology

    Saint-Quentin

  • Hautepierre Hospital, Department of Hematology and Oncology

    Strasbourg, 97098

Other trials in France

Germany8 sites

  • Gemeinschaftspraxis Drs. Klausmann

    Aschaffenburg, 63739

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09113

  • Universitätsklinik Köln

    Cologne, 50924

  • Klinik für Innere Medizin III

    Frankfurt (a.M.), 65929

  • Universitaetsklinikum Halle

    Halle, 06120

  • St. Marien Hospital Hamm

    Hamm, 59071

  • Klinikum Nürnberg Nord

    Nuremberg, 90419

  • Klinikum Mutterhaus der Borromäerinnen

    Trier, 54290

Other trials in Germany

Poland8 sites

  • Independent Public Healthcare Facility Municipal Hospital Group

    Chorzów, 41-500

  • Marine Hospital of Polish Red Cross, Department of Chemotheraphy

    Gdynia, 81-519

  • Silesia Medical University, Department of Hematology and Bone Marrow Transplantation

    Katowice, 40-032

  • Malopolskie Medical Center S.C. , Department of Hematology

    Krakow, 30-510

  • Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz

    Lodz, 93-513

  • Oncology Center of Lublin Land, Department of Clinical Oncology

    Lublin, 20-090

  • Institute of Hematology and Transfusion Medicine, Clinic of Hematology

    Warsaw, 02-776

  • Wroclaw Medical University, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation

    Wroclaw, 50-367

Other trials in Poland

Bulgaria6 sites

  • UMHAT "Sveti Georgi", Plovdiv, Clinical Hematology Clinic

    Plovdiv, 4002

  • UMHAT "Sveti Georgi", Plovdiv, Department of Medical Oncology

    Plovdiv, 4002

  • MHAT "Tokuda Hospital Sofia", Hematology Clinic

    Sofia, 1407

  • University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Department of Clinical Hematology

    Sofia, 1431

  • Specialized Hospital For Active Treatment Of Hematological Diseases, Sofia, Clinical Hematology Clinic

    Sofia, 1756

  • MHAT Hristo Botev, Vratsa, First Department of Internal Medicine

    Vratsa, 3000

Other trials in Bulgaria

Russia6 sites

  • Federal State Public Institution: Main Military Clinical Hospital n.a. N.N. Burdenko of the Russian Ministry of Defense

    Moscow, 105229

  • Moscow State Budget Medical Institution: City Clinical Hospital n.a. S.P.Botkin

    Moscow

  • State Medical Institution: Republican Hospital named after V.A. Baranov

    Petrozavodsk, 18500

  • St. Petersburg Clinical Research and Practical Center for Specialized Types of Medical Care

    Saint Petersburg, 197758

  • State Healthcare Institution: Republican Clinical Oncology Center

    Ufa, 450054

  • State Budget Healthcare Institution of Sverdlovsk region: Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg, 620102

Other trials in Russia

Spain6 sites

  • A Coruña University Hospital

    A Coruña, 15006

  • Hospital Universitario Vall Hebrón

    Barcelona, 08035

  • Hospital Iniversitario Puerta del Mar

    Cadiz, 11009

  • Institut Català de Oncologia (ICO), Hospital Dr Trueta

    Girona, 17007

  • Hospital Iniversitario La Paz

    Madrid, 28046

  • Hospital Universitario Araba

    Vitoria-Gasteiz, 01009

Other trials in Spain

Czechia5 sites

  • University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology

    Brno, 62500

  • University Hospital Hradec Kralove, 4th Department of Internal Medicne, Clinical Hematology

    Hradec Králové, 500 05

  • University Hospital Ostrava, Institute of Clinical Hematology

    Ostrava, 70852

  • University Hospital Kralovske Vinohrady, Department of Clinical Hematology

    Prague, 10034

  • General University Hospital in Prague, 1st Department of Internal Medicine - Department of Hematology

    Prague, 128 20

Other trials in Czechia

Slovakia4 sites

  • University Hospital with Outpatient Clinic F.D. Roosevelt Banska Bystrica, Department of Hematology

    Banská Bystrica, 975 17

  • National Cancer Institute, Department of Hematology and Transfusiology

    Bratislava, 83310

  • University Hospital Martin, Department of Hematology and Transfusiology

    Martin, 3659

  • J. A. Reiman University Hospital with Polyclinic in Presov

    Prešov, 08181

Other trials in Slovakia

Ukraine4 sites

  • Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center

    Cherkasy, 18009

  • Kharkiv Regional Clinical Oncology Center

    Kharkiv, 61070

  • National Institute of Cancer

    Kyiv, 03022

  • State Institution: Institute of Blood Pathology and Transfusion Medicine

    Lviv, 79044

Other trials in Ukraine

Austria3 sites

  • Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)

    Innsbruck, 6020

  • Hospital Elisabethinen Linz, Internal Department 1 - Hemato-Oncology

    Linz, 4020

  • Hanusch Hospital, Department of Internal Medicine III

    Vienna, 1140

Other trials in Austria

Belgium3 sites

  • Saint Luc University Hospital, Department of Hematology

    Brussels, 1200

  • General Hospital Delta, Hematology Department

    Roeselare, 8800

  • General Hospital Turnhout, Hematology Department

    Turnhout, 2300

Other trials in Belgium

Hungary3 sites

  • St. Istvan and St. Laszlo Hospital of Budapest

    Budapest, H-1097

  • University of Debrecen

    Debrecen, H-4032

  • Moritz Kaposi General Hospital

    Kaposvár, 7400

Other trials in Hungary

Romania3 sites

  • Rapid Diagnosis Polyclinic SA

    Brasov

  • Fundeni Clinical Institute Center for Hematology and Bone Marrow Transplantation

    Bucharest, 022328

  • Bucharest University Emergency Hospital, Hematology Clinic

    Bucharest, 050098

Other trials in Romania

United Kingdom3 sites

  • Beatson West of Scotland Cancer Center

    Glasgow, G12 0YN

  • St. George's Healthcare NHS Trust

    London, SW17 0QT

  • Christie Hospital, Department of Medical Oncology

    Manchester, M20 4BX

Other trials in United Kingdom

Denmark1 site

  • Aalborg University Hospital, Department of Hematology

    Aalborg, 9100

Other trials in Denmark

About this study

Official title: A Randomized Multicenter Study Comparing Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed After Therapy With CHOP-R or an Equivalent Regimen and Are Ineligible for Stem Cell Transplant

The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), or follicular grade 3 lymphoma.

Read the detailed description

Eligible patients will be randomized to treatment with pixantrone plus rituximab or gemcitabine plus rituximab in up to six 28-day cycles. At the time patients experience progressive disease during study treatment, early follow- up, or intermediate follow-up, they enter the survival follow up period. Patients who complete study treatment or discontinue study treatment for any other reason will participate in the follow-up periods.

Early Follow-Up: After treatment completion or discontinuation, patient will enter a 24-week follow-up period.

Intermediate Follow-Up: After completing the 24-week early follow-up period, patient will enter an additional 72-week follow-up period.

Survival Follow-Up: All patients will be monitored for survival.

Being tested
Pixantrone + Rituximab, Gemcitabine + Rituximab
Keywords
non-hodgkin lymphoma, DLBCL, relapsed, aggressive NHL, Diffuse large B-cell lymphoma, Rituximab, Rituxan, Pixantrone, NHL, non hodgkin's lymphoma, de novo DLBCL, DLBCL transformed from Indolent Lymphoma, Follicular Grade 3 Lymphoma
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pixantrone + RituximabDrug

    Pixantrone + Rituximab: Rituximab 375 mg/m2 IV on day 1 and pixantrone 50 mg/m2 (equivalent to 85mg/m2 pixantrone dimaleate)IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.

  • Gemcitabine + RituximabDrug

    Gemcitabine + Rituximab: Rituximab 375 mg/m2 IV on day 1 and gemcitabine 1000 mg/m2 IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.

Study groups in NCT01321541
Study groupRoleWhat they receive
Pixantrone + RituximabExperimentalPixantrone and Rituximab
Receives: Drug: Pixantrone + Rituximab
Gemcitabine + RituximabActive comparatorGemcitabine and Rituximab
Receives: Drug: Gemcitabine + Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    PFS is defined as the time of randomization to the date of disease progression or death due to any cause (whichever occurs first)

    Measured: From the date of randomization to the date of progressive disease or death due to any cause (whichever is first reported) (Up to 100 weeks)

Secondary outcomes (4)

  1. Overall Survival

    Overall survival is from randomization to death due to any cause

    Measured: From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)

  2. Complete Response Rate

    CRR is defined as the proportion of patients who achieve a Complete Response (CR) without additional therapy. CR is defined as the disappearance of all target lesions.

    Measured: From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)

  3. Overall Response Rate

    ORR is defined as the proportion of patients who achieve a CR or PR without additional therapy.

    Measured: From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)

  4. Number of Treatment Emergent Adverse Events (TEAE) Related to Study Drug

    The number of Participants with Treatment Emergent Adverse Events (TEAE) related to study drug (pixantrone or gemcitabine)

    Measured: From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2011 (estimated)
  2. Study start20 Apr 2011
  3. Primary completion28 Jun 2018
  4. Study completion14 Sep 2018

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
312 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01321541
Sponsor's protocol ID
PIX306 (PIX-R Trial)
Acronym
PIX-R
Status last verified
Sep 2021
First submitted
21 Mar 2011
Last updated
19 Nov 2021
Data monitoring committee
Yes

Publications

  • Pettengell R, Dlugosz-Danecka M, Andorsky D, Belada D, Georgiev P, Quick D, Singer JW, Singh SB, Pallis A, Egorov A, Salles G. Pixantrone plus rituximab versus gemcitabine plus rituximab in patients with relapsed aggressive B-cell non-Hodgkin lymphoma not eligible for stem cell transplantation: a phase 3, randomized, multicentre trial (PIX306). Br J Haematol. 2020 Jan;188(2):240-248. doi: 10.1111/bjh.16255. Epub 2019 Dec 27.

    PubMed 31879945

  • Belada D, Georgiev P, Dakhil S, Inhorn LF, Andorsky D, Beck JT, Quick D, Pettengell R, Daly R, Dean JP, Pavlyuk M, Failloux N, Hubel K. Pixantrone-rituximab versus gemcitabine-rituximab in relapsed/refractory aggressive non-Hodgkin lymphoma. Future Oncol. 2016 Aug;12(15):1759-68. doi: 10.2217/fon-2016-0137. Epub 2016 Apr 20.

    PubMed 27093976

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pixantrone + Rituximab and Gemcitabine + Rituximab in people with Diffuse Large B-cell Lymphoma and de Novo DLBCL, run by CTI BioPharma at 131 sites in 17 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 5 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 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in United States, Italy, France, Germany, Poland and 12 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 19 Nov 2021). 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?

Progression Free Survival (PFS) (time frame: From the date of randomization to the date of progressive disease or death due to any cause (whichever is first reported) (Up to 100 weeks)). 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 NCT01321541, which also lists 2 linked publications.

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 19 Nov 2021.

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