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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 (PIX-R)

Primary Purpose

Diffuse Large B-cell Lymphoma, de Novo DLBCL, DLBCL Transformed From Indolent Lymphoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pixantrone + Rituximab
Gemcitabine + Rituximab
Sponsored by
CTI BioPharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of DLBCL (de novo DLBCL, or transformed from indolent lymphoma) or follicular grade 3 lymphoma on the basis of tissue biopsy.
  2. 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.
  3. Received rituximab containing a multi-agent therapy for the treatment of NHL.
  4. Not eligible for high-dose chemotherapy and stem cell transplant.
  5. 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.

Exclusion Criteria:

  1. 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.
  2. Prior treatment with cumulative dose of doxorubicin or equivalent exceeding 450 mg/m2
  3. Any experimental therapy ≤ 28 days prior to randomization
  4. 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
  5. Any contraindication or known allergy or hypersensitivity to any study drugs
  6. 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.

Sites / Locations

  • Arizona Clinical Research Center
  • Arizona Oncology Associates
  • Highlands Oncology Group
  • Highlands Oncology Group
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • George Washington University Department of Medicine
  • Integrated Community Oncology Network-St. Vincent's
  • Integrated Community Oncology Network-Southside
  • Integrated Community Oncology Network
  • Carle Physician Group
  • Cancer Care Specialists of Central Illinois
  • Crossroads Cancer Center
  • Carle Foundation Physician Services
  • Carle Cancer Center
  • Cancer Center of Kansas
  • Cancer Center of Kansas
  • Baptist Hospital East
  • Harry and Jeanette Weinberg Cancer Institute at Franklin Square
  • Center for Cancer and Blood Disorders, PC
  • Cancer & Hematology Center of Western Michigan
  • Metro Minnesota CCOP-Unity Hospital
  • Metro Minnesota CCOP-St. Johns
  • Metro Minnesota Community Clinical Oncology Program
  • Metro Minnesota Community Clinical Oncology Program
  • Metro Minnesota CCOP-Regions Hospital
  • Missouri Cancer Associates
  • Nebraska Hematology-Oncology, PC
  • Hematology-Oncology Associates of Northern New Jersey
  • North Shore Hematology/Oncology Associates
  • Gabrail Cancer Center
  • Gabrail Cancer Center
  • Toledo Clinical Cancer Center
  • Mercy Cancer Center at St. Anne's
  • Toledo Clinic Cancer Center-Toledo
  • Northwest Cancer Specialists, PC
  • Northwest Cancer Specialists, PC
  • Northwest Cancer Specialists, PC
  • Fox Chase Cancer Center
  • Upstate Oncology Associates
  • South Carolina Cancer Specialists
  • South Carolina Cancer Specialists
  • Joe Arrington Cancer Research and Treatment Center
  • Cancer Care Centers of South Texas-HOAST
  • Cancer Care Centers of South Texas-HOAST
  • Blue Ridge Cancer Care
  • Northwest Cancer Specialists, PC
  • Northwest Cancer Specialists, PC
  • Saint Vincent Hospital Green Bay Oncology
  • Green Bay Oncology-St. Mary's Hospital MC
  • Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)
  • Hospital Elisabethinen Linz, Internal Department 1 - Hemato-Oncology
  • Hanusch Hospital, Department of Internal Medicine III
  • Saint Luc University Hospital, Department of Hematology
  • General Hospital Delta, Hematology Department
  • General Hospital Turnhout, Hematology Department
  • UMHAT "Sveti Georgi", Plovdiv, Clinical Hematology Clinic
  • UMHAT "Sveti Georgi", Plovdiv, Department of Medical Oncology
  • MHAT "Tokuda Hospital Sofia", Hematology Clinic
  • University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Department of Clinical Hematology
  • Specialized Hospital For Active Treatment Of Hematological Diseases, Sofia, Clinical Hematology Clinic
  • MHAT Hristo Botev, Vratsa, First Department of Internal Medicine
  • University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
  • University Hospital Hradec Kralove, 4th Department of Internal Medicne, Clinical Hematology
  • University Hospital Ostrava, Institute of Clinical Hematology
  • University Hospital Kralovske Vinohrady, Department of Clinical Hematology
  • General University Hospital in Prague, 1st Department of Internal Medicine - Department of Hematology
  • Aalborg University Hospital, Department of Hematology
  • Service d'hématologie clinique, Avenue Laennec Salouel
  • Centre hopitalier de la cote basque
  • Centre hospitalier de Beziers
  • Polyclinique de Bordeaux nord Acquitaine
  • Centre hospitalier du Mans
  • Centre hospitalier Lyon Sud
  • Saint Quentin Hospital Center, Department of Oncology-Hematology
  • Hautepierre Hospital, Department of Hematology and Oncology
  • Gemeinschaftspraxis Drs. Klausmann
  • Klinikum Chemnitz gGmbH
  • Klinik für Innere Medizin III
  • Universitaetsklinikum Halle
  • St. Marien Hospital Hamm
  • Universitätsklinik Köln
  • Klinikum Nürnberg Nord
  • Klinikum Mutterhaus der Borromäerinnen
  • St. Istvan and St. Laszlo Hospital of Budapest
  • University of Debrecen
  • Moritz Kaposi General Hospital
  • University Hospital "Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi"
  • Bologna University Hospital Authority St. Orsola-Malpighi Polyclinic
  • Scientific Institute of Romagna for the Study and Treatment of Cancer (I.R.S.T.) S.R.L.
  • "Ospedali Riuniti Villa Sofia-Cervello" Hospital
  • Romagna Local Health Authority (AUSL Romagna) - "Santa Maria delle Croci"
  • Romagna Local Health Authority (AUSL Romagna) - "Infermi" Hospital
  • Siena University Hospital Authority Santa Maria alle Scotte Polyclinic
  • Santa Maria Hospital
  • A.O.U. Città della Salute e della Scienza di Torino
  • Independent Public Healthcare Facility Municipal Hospital Group
  • Marine Hospital of Polish Red Cross, Department of Chemotheraphy
  • Silesia Medical University, Department of Hematology and Bone Marrow Transplantation
  • Malopolskie Medical Center S.C. , Department of Hematology
  • Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz
  • Oncology Center of Lublin Land, Department of Clinical Oncology
  • Institute of Hematology and Transfusion Medicine, Clinic of Hematology
  • Wroclaw Medical University, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation
  • Rapid Diagnosis Polyclinic SA
  • Fundeni Clinical Institute Center for Hematology and Bone Marrow Transplantation
  • Bucharest University Emergency Hospital, Hematology Clinic
  • State Budget Healthcare Institution of Sverdlovsk region: Sverdlovsk Regional Clinical Hospital #1
  • Federal State Public Institution: Main Military Clinical Hospital n.a. N.N. Burdenko of the Russian Ministry of Defense
  • Moscow State Budget Medical Institution: City Clinical Hospital n.a. S.P.Botkin
  • State Medical Institution: Republican Hospital named after V.A. Baranov
  • St. Petersburg Clinical Research and Practical Center for Specialized Types of Medical Care
  • State Healthcare Institution: Republican Clinical Oncology Center
  • University Hospital with Outpatient Clinic F.D. Roosevelt Banska Bystrica, Department of Hematology
  • National Cancer Institute, Department of Hematology and Transfusiology
  • University Hospital Martin, Department of Hematology and Transfusiology
  • J. A. Reiman University Hospital with Polyclinic in Presov
  • A Coruña University Hospital
  • Hospital Universitario Vall Hebrón
  • Hospital Iniversitario Puerta del Mar
  • Institut Català de Oncologia (ICO), Hospital Dr Trueta
  • Hospital Iniversitario La Paz
  • Hospital Universitario Araba
  • Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center
  • Kharkiv Regional Clinical Oncology Center
  • National Institute of Cancer
  • State Institution: Institute of Blood Pathology and Transfusion Medicine
  • Beatson West of Scotland Cancer Center
  • St. George's Healthcare NHS Trust
  • Christie Hospital, Department of Medical Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pixantrone + Rituximab

Gemcitabine + Rituximab

Arm Description

Pixantrone and Rituximab

Gemcitabine and Rituximab

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Overall Survival
Overall survival is from randomization to death due to any cause
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.
Overall Response Rate
ORR is defined as the proportion of patients who achieve a CR or PR without additional therapy.
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)

Full Information

First Posted
March 21, 2011
Last Updated
October 21, 2021
Sponsor
CTI BioPharma
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1. Study Identification

Unique Protocol Identification Number
NCT01321541
Brief Title
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
Acronym
PIX-R
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 20, 2011 (Actual)
Primary Completion Date
June 28, 2018 (Actual)
Study Completion Date
September 14, 2018 (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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-cell Lymphoma, de Novo DLBCL, DLBCL Transformed From Indolent Lymphoma, Follicular Grade 3 Lymphoma
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pixantrone + Rituximab
Arm Type
Experimental
Arm Description
Pixantrone and Rituximab
Arm Title
Gemcitabine + Rituximab
Arm Type
Active Comparator
Arm Description
Gemcitabine and Rituximab
Intervention Type
Drug
Intervention Name(s)
Pixantrone + Rituximab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine + Rituximab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS is defined as the time of randomization to the date of disease progression or death due to any cause (whichever occurs first)
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)
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival is from randomization to death due to any cause
Time Frame
From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)
Title
Complete Response Rate
Description
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.
Time Frame
From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)
Title
Overall Response Rate
Description
ORR is defined as the proportion of patients who achieve a CR or PR without additional therapy.
Time Frame
From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)
Title
Number of Treatment Emergent Adverse Events (TEAE) Related to Study Drug
Description
The number of Participants with Treatment Emergent Adverse Events (TEAE) related to study drug (pixantrone or gemcitabine)
Time Frame
From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)
Other Pre-specified Outcome Measures:
Title
Individual Concentration-time Profiles of Patients Will be Compared to Existing Data Using Simulations (Visual Predictive Checks)
Description
To characterize the PK profile of pixantrone when co-administered with rituximab. Plasma samples for PK analysis will be collected relative to the D-1 dose of pixantrone in one of the 6 treatment cycles for each participating patient. The goal is to enroll approx. 20 patients, active at 20 sites- Beatson West of Scotland Cancer Center, Uni. Hospital Kralovske Vinohrady, Uni. Hospital Hradec Kralove Hematooncology, Hospital Nuernberg, St. Marien Hospital Hamm, Puerta del Mar Hospital, Tokuda Hospital Sofia, National Center of Hematology & Transfusiology, UMHAT "SV. IVAN RILSKI", Moritz Kaposi General Hospital, Uni. of Debrecen, Polish Red Cross Marine Hospital, Kharkiv Regional Clinical Oncology Center, National Inst. of Cancer Ukraine, Cherkasy Regional Oncology Center, Inst. of Blood Pathology & Transfusion Medicine, Uni. Hospital Martin, National Onclogy Inst., Uni. Hospital with Outpatient Clinic F.D. Roosevelt Banska Bystrica, Uni. Hospital J.A. Reiman Presov
Time Frame
within 1 hour of initiation of infusion to 24-48 hours after start of pixantrone infusion
Title
To Generate Individual Secondary PK Parameters (eg, Exposure, Half-life Etc.) Using Descriptive Statistics
Description
To characterize the PK profile of pixantrone when co-administered with rituximab. Plasma samples for PK analysis will be collected relative to the D-1 dose of pixantrone in one of the 6 treatment cycles for each participating patient. The goal is to enroll approx. 20 patients, active at 20 sites- Beatson West of Scotland Cancer Center, Uni. Hospital Kralovske Vinohrady, Uni. Hospital Hradec Kralove Hematooncology, Hospital Nuernberg, St. Marien Hospital Hamm, Puerta del Mar Hospital, Tokuda Hospital Sofia, National Center of Hematology & Transfusiology, UMHAT "SV. IVAN RILSKI", Moritz Kaposi General Hospital, Uni. of Debrecen, Polish Red Cross Marine Hospital, Kharkiv Regional Clinical Oncology Center, National Inst. of Cancer Ukraine, Cherkasy Regional Oncology Center, Inst. of Blood Pathology & Transfusion Medicine, Uni. Hospital Martin, National Onclogy Inst., Uni. Hospital with Outpatient Clinic F.D. Roosevelt Banska Bystrica, Uni. Hospital J.A. Reiman Presov
Time Frame
within 1 hour of initiation of infusion to 24-48 hours after start of pixantrone infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simran B Singh, MS, GWCP
Organizational Affiliation
Sr. Director, Clinical Operations
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Highlands Oncology Group
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Facility Name
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
George Washington University Department of Medicine
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Integrated Community Oncology Network-St. Vincent's
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Integrated Community Oncology Network-Southside
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Integrated Community Oncology Network
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Carle Physician Group
City
Danville
State/Province
Illinois
ZIP/Postal Code
61832
Country
United States
Facility Name
Cancer Care Specialists of Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Crossroads Cancer Center
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Carle Foundation Physician Services
City
Mattoon
State/Province
Illinois
ZIP/Postal Code
61938
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67215
Country
United States
Facility Name
Baptist Hospital East
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Harry and Jeanette Weinberg Cancer Institute at Franklin Square
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Center for Cancer and Blood Disorders, PC
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Cancer & Hematology Center of Western Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49450
Country
United States
Facility Name
Metro Minnesota CCOP-Unity Hospital
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Metro Minnesota CCOP-St. Johns
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Metro Minnesota Community Clinical Oncology Program
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Metro Minnesota Community Clinical Oncology Program
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
Metro Minnesota CCOP-Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Missouri Cancer Associates
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Nebraska Hematology-Oncology, PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Hematology-Oncology Associates of Northern New Jersey
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
North Shore Hematology/Oncology Associates
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Gabrail Cancer Center
City
Dover
State/Province
Ohio
ZIP/Postal Code
44622
Country
United States
Facility Name
Toledo Clinical Cancer Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Facility Name
Mercy Cancer Center at St. Anne's
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Toledo Clinic Cancer Center-Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Northwest Cancer Specialists, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Northwest Cancer Specialists, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Northwest Cancer Specialists, PC
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Upstate Oncology Associates
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
South Carolina Cancer Specialists
City
Hardeeville
State/Province
South Carolina
ZIP/Postal Code
29927
Country
United States
Facility Name
South Carolina Cancer Specialists
City
Hilton Head Island
State/Province
South Carolina
ZIP/Postal Code
29926
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Cancer Care Centers of South Texas-HOAST
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Cancer Care Centers of South Texas-HOAST
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Blue Ridge Cancer Care
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Northwest Cancer Specialists, PC
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
Northwest Cancer Specialists, PC
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98686
Country
United States
Facility Name
Saint Vincent Hospital Green Bay Oncology
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Green Bay Oncology-St. Mary's Hospital MC
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Hospital Elisabethinen Linz, Internal Department 1 - Hemato-Oncology
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Hanusch Hospital, Department of Internal Medicine III
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Saint Luc University Hospital, Department of Hematology
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
General Hospital Delta, Hematology Department
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
General Hospital Turnhout, Hematology Department
City
Turnhout
ZIP/Postal Code
2300
Country
Belgium
Facility Name
UMHAT "Sveti Georgi", Plovdiv, Clinical Hematology Clinic
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
UMHAT "Sveti Georgi", Plovdiv, Department of Medical Oncology
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
MHAT "Tokuda Hospital Sofia", Hematology Clinic
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Department of Clinical Hematology
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Specialized Hospital For Active Treatment Of Hematological Diseases, Sofia, Clinical Hematology Clinic
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
MHAT Hristo Botev, Vratsa, First Department of Internal Medicine
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
University Hospital Hradec Kralove, 4th Department of Internal Medicne, Clinical Hematology
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
University Hospital Ostrava, Institute of Clinical Hematology
City
Ostrava
ZIP/Postal Code
70852
Country
Czechia
Facility Name
University Hospital Kralovske Vinohrady, Department of Clinical Hematology
City
Prague
ZIP/Postal Code
10034
Country
Czechia
Facility Name
General University Hospital in Prague, 1st Department of Internal Medicine - Department of Hematology
City
Prague
ZIP/Postal Code
128 20
Country
Czechia
Facility Name
Aalborg University Hospital, Department of Hematology
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Service d'hématologie clinique, Avenue Laennec Salouel
City
Amiens, Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
Centre hopitalier de la cote basque
City
Bayonne
ZIP/Postal Code
64190
Country
France
Facility Name
Centre hospitalier de Beziers
City
Beziers
ZIP/Postal Code
34500
Country
France
Facility Name
Polyclinique de Bordeaux nord Acquitaine
City
Bordeaux
ZIP/Postal Code
33077
Country
France
Facility Name
Centre hospitalier du Mans
City
Le Mans Cedex 03
ZIP/Postal Code
72037
Country
France
Facility Name
Centre hospitalier Lyon Sud
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Saint Quentin Hospital Center, Department of Oncology-Hematology
City
Saint-Quentin
Country
France
Facility Name
Hautepierre Hospital, Department of Hematology and Oncology
City
Strasbourg Cedex
ZIP/Postal Code
97098
Country
France
Facility Name
Gemeinschaftspraxis Drs. Klausmann
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
ZIP/Postal Code
09113
Country
Germany
Facility Name
Klinik für Innere Medizin III
City
Frankfurt (a.M.)
ZIP/Postal Code
65929
Country
Germany
Facility Name
Universitaetsklinikum Halle
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
St. Marien Hospital Hamm
City
Hamm
ZIP/Postal Code
59071
Country
Germany
Facility Name
Universitätsklinik Köln
City
Köln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Klinikum Nürnberg Nord
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Klinikum Mutterhaus der Borromäerinnen
City
Trier
ZIP/Postal Code
54290
Country
Germany
Facility Name
St. Istvan and St. Laszlo Hospital of Budapest
City
Budapest
ZIP/Postal Code
H-1097
Country
Hungary
Facility Name
University of Debrecen
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
Moritz Kaposi General Hospital
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
University Hospital "Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi"
City
Ancona
ZIP/Postal Code
70126
Country
Italy
Facility Name
Bologna University Hospital Authority St. Orsola-Malpighi Polyclinic
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Scientific Institute of Romagna for the Study and Treatment of Cancer (I.R.S.T.) S.R.L.
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
"Ospedali Riuniti Villa Sofia-Cervello" Hospital
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Romagna Local Health Authority (AUSL Romagna) - "Santa Maria delle Croci"
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Romagna Local Health Authority (AUSL Romagna) - "Infermi" Hospital
City
Rimini
ZIP/Postal Code
47900
Country
Italy
Facility Name
Siena University Hospital Authority Santa Maria alle Scotte Polyclinic
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Santa Maria Hospital
City
Terni
ZIP/Postal Code
5100
Country
Italy
Facility Name
A.O.U. Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Independent Public Healthcare Facility Municipal Hospital Group
City
Chorzów
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Marine Hospital of Polish Red Cross, Department of Chemotheraphy
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Silesia Medical University, Department of Hematology and Bone Marrow Transplantation
City
Katowice
ZIP/Postal Code
40-032
Country
Poland
Facility Name
Malopolskie Medical Center S.C. , Department of Hematology
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Oncology Center of Lublin Land, Department of Clinical Oncology
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Institute of Hematology and Transfusion Medicine, Clinic of Hematology
City
Warsaw
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Wroclaw Medical University, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Rapid Diagnosis Polyclinic SA
City
Brasov
Country
Romania
Facility Name
Fundeni Clinical Institute Center for Hematology and Bone Marrow Transplantation
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Bucharest University Emergency Hospital, Hematology Clinic
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
State Budget Healthcare Institution of Sverdlovsk region: Sverdlovsk Regional Clinical Hospital #1
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Federal State Public Institution: Main Military Clinical Hospital n.a. N.N. Burdenko of the Russian Ministry of Defense
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Moscow State Budget Medical Institution: City Clinical Hospital n.a. S.P.Botkin
City
Moscow
Country
Russian Federation
Facility Name
State Medical Institution: Republican Hospital named after V.A. Baranov
City
Petrozavodsk
ZIP/Postal Code
18500
Country
Russian Federation
Facility Name
St. Petersburg Clinical Research and Practical Center for Specialized Types of Medical Care
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
State Healthcare Institution: Republican Clinical Oncology Center
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
University Hospital with Outpatient Clinic F.D. Roosevelt Banska Bystrica, Department of Hematology
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
National Cancer Institute, Department of Hematology and Transfusiology
City
Bratislava
ZIP/Postal Code
83310
Country
Slovakia
Facility Name
University Hospital Martin, Department of Hematology and Transfusiology
City
Martin
ZIP/Postal Code
3659
Country
Slovakia
Facility Name
J. A. Reiman University Hospital with Polyclinic in Presov
City
Presov
ZIP/Postal Code
08181
Country
Slovakia
Facility Name
A Coruña University Hospital
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Vall Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Iniversitario Puerta del Mar
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Institut Català de Oncologia (ICO), Hospital Dr Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Iniversitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Araba
City
Vitoria
ZIP/Postal Code
01009
Country
Spain
Facility Name
Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Kharkiv Regional Clinical Oncology Center
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
National Institute of Cancer
City
Kyiv
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
State Institution: Institute of Blood Pathology and Transfusion Medicine
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Beatson West of Scotland Cancer Center
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
St. George's Healthcare NHS Trust
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Christie Hospital, Department of Medical Oncology
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31879945
Citation
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.
Results Reference
result
PubMed Identifier
27093976
Citation
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.
Results Reference
derived

Learn more about this trial

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

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