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A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy

Primary Purpose

Lymphoma, Non-Hodgkin

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Inotuzumab ozogamicin
Rituximab
rituximab + gemcitabine
rituximab +bendamustine
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring inotuzumab ozogamicin, aggressive Non-Hodgkin lymphoma, diffuse large b-cell lymphoma, relapsed/refractory lymphoma

Eligibility Criteria

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

Inclusion Criteria:

-

Exclusion Criteria:

-

Sites / Locations

  • Disney Family Cancer Center at Providence St Joseph Medical Center
  • Providence St Joseph Medical Center
  • Hematology-Oncology Medical Group of Fresno Inc
  • Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services
  • Clinical Research Unit
  • Peter Morton Medical Plaza
  • Ronald Reagan UCLA Medical Center
  • Sansum Clinic
  • UCLA Santa Monica Hematology Oncology
  • Sansum Clinic
  • Howard University Hospital
  • Mount Sinai Comprehensive Cancer Center at Aventura
  • University Cancer Institute
  • 21st Century Oncology of Jacksonville, LLC
  • Davis Cancer Pavilion and Shands Medical Plaza
  • Shands Cancer Hospital at the University of Florida
  • UF Health Davis Cancer Pavillion and Shands Med Plaza
  • UF Health Shands Cancer Hospital
  • Shands Hospital at the University of Florida
  • UF Health Shands Hospital
  • 21st Century Oncology of Jacksonville, LLC
  • 21st Century Oncology of Jacksonville, LLC
  • Baptist Cancer Institute
  • Baptist Medical Center
  • 21st Century Oncology of Jacksonville, LLC
  • 21st Century Oncology of Jacksonville, Inc.
  • Medical Specialists Of The Palm Beaches
  • Mount Sinai Comprehensive Cancer Center
  • Mount Sinai Medical Center
  • Advanced Medical Specialties
  • Mercy Hospital
  • Mercy Research Institute
  • 21st Century Oncology of Jacksonville, LLC
  • Georgia Regents Medical Cancer Pharmacy
  • Georgia Regents University
  • Kootenai Cancer Center
  • Kootenai Cancer Center
  • Decatur Memorial Hospital (DMH)
  • Floyd Memorial Cancer Center of Indiana
  • University of Kansas Medical Center
  • University of Kansas Cancer Center and Medical Pavilion
  • University of Kentucky A.B. Chandler Medical Center
  • University of Kentucky Markey Cancer Center
  • Tulane University Hospital and Clinic
  • Barbara Ann Karmanos Cancer Institute
  • Barbara Ann Karmanos Cancer Institute at farmington Hills
  • Park Nicollet Frauenshuh Cancer Center
  • Barnes-Jewish Hospital
  • Washington University in St Louis
  • Washington University School of Medicine
  • Washington University
  • Barnes-Jewish St. Peters
  • Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center
  • Beth Israel Medical Center;
  • Beth Israel Comprehensive Cancer Center
  • St Luke's- Roosevelt Hospital Center
  • Memorial Sloan Kettering Cancer Center
  • Stony Brook University Medical Center, The Cancer Center
  • Stony Brook University Medical Center
  • University Hospital
  • West Chester Hospital Medical Building
  • OU Medical Center Presbyterian Professional Building
  • OU Medical Center Presbyterian Tower
  • Peggy and Charles Stephenson Cancer Center (chemo & infusion)
  • Peggy and Charles Stephenson Cancer Center (clinic location)
  • Good Samaritan Hospital Corvallis
  • Good Samaritan Hospital, Corvallis
  • Samaritan Ambulatory Infusion Services
  • Samaritan Pacific Coast Hospital
  • Penn State Milton S. Hershey Medical Center
  • Guthrie Clinic, Ltd.
  • Robert Packer Hospital
  • Thompson Oncology Group
  • Thompson Oncology Group
  • Thompson Oncology Group
  • Thompson Oncology Group
  • University Hospital - St. Paul
  • University Hospital - Zale Lipshy
  • Baylor University Medical Center
  • Baylor: Charles A. Sammons Cancer Center
  • Simmons Comprehensive Cancer Center
  • The University of Texas MD Anderson Cancer Center
  • Universitaire Ziekenhuizen Leuven
  • Institut Jules Bordet
  • Grand Hopital de Charleroi
  • H.-Hartziekenhuis Roeselare-Menen
  • St Augustinus Ziekenhuis
  • Cliniques universitaires UCL de Mont-Godinne,
  • UMBAL Sveti Georgi, Klinika po hematologia
  • SBAL na Hematologichnichni Zabolyavania,CTH Sofia
  • Spetsializirana Bolnitsa za Aktivno Lechenie na Hematologichni Zabolyavania, CTH Sofia
  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • Sunnybrook Health Sciences Centre
  • Centre Hospitalier Universitaire de Sherbrooke (CHUS), Hopital Fleurimont
  • University Hospital Zagreb
  • University Hospital Dubrava Department of Internal Medicine Division of Hematology
  • Fakultni nemocnice Kralovske Vinohrady
  • Fakultni nemocnice Brno
  • Département Pharmacie
  • Institut Paoli Calmettes
  • Hospital Universitaire Andre Mignot
  • Hopital Andre Mignot
  • Centre Leon Berard
  • CHU Saint Eloi
  • Hopital du haut Leveque
  • Centre Henri Becquerel
  • Universitaetsklinikum Aachen
  • Sozialstiftung Bamberg
  • Charite Campus Benjamin Franklin
  • Charite Campus Virchow-Klinikum
  • Universitaetsklinikum Mainz
  • TU Muenchen III. Medizinische Klinik
  • Universitaetsklinik Ulm
  • Egyesitett Szent Istvan es Szent Laszlo Korhaz /
  • DEOEC, Belgyogyaszati Intezet
  • Somongy Megyei Kaposi Mor Okato Korhaz/ Belgyogyaszati osztaly
  • Kodlikeri Memorial Hospital
  • Sahyadri Clinical Research and Development Center
  • OEC Record Management Company Pvt. Ltd.,
  • Sahyadri Speciality Hospital
  • Bon Secours Hospital
  • Nagoya Daini Red Cross Hospital
  • National Cancer Center Hospital East
  • Ehime University Hospital
  • Gunma University Hospital
  • Tohoku University Hospital
  • Matsushita Memorial Hospital
  • Shizuoka Cancer Center
  • National Cancer Center Hospital
  • Cancer Institute Hospital, Japanese Foundation For Cancer Research
  • Akita University Hospital
  • National Kyushu Cancer Center
  • Tokai University Hospital
  • University Hospital, Kyoto Prefectural University of Medicine
  • Klaipeda Seamen's Hospital, Public Institution, department of Oncology
  • Instituto Biomédico de Investigación A.C.
  • Niepubliczny Zaklad Opieki Zdrowotnej AVI Diagnostyka Obrazowa
  • Klinika Nowotworow Ukladu Chlonnego
  • Advanced Infusion Services
  • Hospital Espanol Auxilio Mutuo de Puerto Rico Inc
  • Federal State Budgetary Institution Hematology Scientific Centre of Ministry of
  • Moscow State Healthcare Institution City clinical hospital S.P. Botkin
  • Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva
  • National University Hospital
  • Singapore General Hospital
  • Narodny onkologicky ustav
  • Hospital Virgen Del Rocio
  • Hospital Universitario De Salamanca
  • Hospital Clinic de Barcelona
  • Hospital Clinic Universitari de Barcelona
  • Institut Catala d'Oncologia-L'Hospitalet
  • Hospital Universitario de Canarias
  • Hospital de la Princesa
  • Universitetssjukhuset
  • Skanes Universitetssjukhus i Lund
  • Chang Gung Medical Foundation - Linkou Branch
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital, Department of Internal Medicine
  • Taipei Veterans General Hospital
  • Hematology Division Department of Medicine Faculty of Medicine Siriraj Hospital Mahidol University
  • Chiang Mai University
  • Regional Treatment and Diagnostic Hematology Center Communal Establishment
  • Department of Oncology and Medical Radiology of State Institution
  • SI"Research Center for Radiation Medicine of NAMS of Ukraine"
  • Barts Cancer Centre Dept Haemato-oncology St. Bartholomew's Hospital Barts Health NHS Trust
  • Chemotherapy Preparative Unit St. Bartholomew's Hospital
  • Department of Medical Oncology St. Bartholomew's Hospital
  • The Christie NHS Foundation Trust - Christie Hospital
  • Department of Clinical Pathology Newcastle upon Tyne Hospitals NHS Foundation Trust Royal Victoria I
  • Department of Clinical Biochemistry Newcastle upon Tyne Hospitals
  • Northern Centre for Cancer Care
  • Nottingham University Hospital
  • Pathology Department Nottingham University Hospital - City Hospital Campus
  • Pharmacy Nottingham University Hospital - City Hospital Campus
  • Local Laboratory Nottingham University Hospital - City Hospital Campus
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Inotuzumab ozogamicin+rituximab

Investigator's choice of (1) rituximab+gemcitabine, or (2) rituximab+bendamustine

Outcomes

Primary Outcome Measures

Overall Survival
Overall Survival (OS) was defined as the time from randomization to death due to any cause, censoring at the date of last contact or the end of the study. The Kaplan-Meier method was used to determine OS. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)
Includes all TEAEs: Any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration..

Secondary Outcome Measures

Progression-Free Survival (PFS)
PFS is defined as time from date of randomization to date of progressive disease (PD, including investigator's claim of clinical progression), date of death from any cause, or initiation of a new treatment for the lymphoma due to persistent/refractory disease. The Kaplan-Meier method was used to determine PFS. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression. PD requires the following: Appearance of any new lesion more than 1.5 cm in any axis during or at the end of treatment, even if other lesions are decreasing in size. At least a 50% increase from nadir in the sum of the product diameters of any previously involved nodes, or in a single involved node, or the size of other lesions. At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis.
Percentage of Participants With A Best Overall Response of CR or Partial Response (PR) Per NCI International Response Criteria for NHL
CR is defined as disappearance of all detectable clinical evidence of disease (including cleared infiltrate on repeat bone marrow aspirate/biopsy if lymphoma involvement of bone marrow before treatment). Partial Response (PR) requires the following: ≥50 % decrease in SPD of the six largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by ≥50% in the SPD, or for single nodules, in the greatest transverse diameter. With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No new sites of disease. The 95% CI was determined using the exact method based on binomial distribution.
Percentage of Participants With A Best Overall Response of CR, Unconfirmed CR (unCR), PR, or Unconfirmed PR (unPR) Per NCI International Response Criteria for NHL
CR is defined as disappearance of all detectable clinical evidence of disease (including cleared infiltrate on repeat bone marrow aspirate/biopsy if lymphoma involvement of bone marrow before treatment). Partial Response (PR) requires the following: ≥50 % decrease in SPD of the six largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by ≥50% in the SPD, or for single nodules, in the greatest transverse diameter. With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No new sites of disease. unCR and unPR means didn't have confirmatory assessment (including bone marrow assessment for CR). The 95% CI was determined using the exact method based on binomial distribution.
Duration of Response
The duration of overall response is measured from the first date of response until the first date that the progressive disease (PD) or death is objectively documented. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.
Health Status as Assessed by the European Quality of Life 5 Dimension (EQ-5D) Questionnaire
EQ-5D consists of a descriptive system and an EQ visual analogue scale. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The scale, the best state is marked 100 and the worst state is marked 0, is to help the participant to say how good or bad a health state is. EQ-5D index, which was reported, was derived based on US weight. The range of EQ-5D index is -0.109 to 1.00. Higher scores mean better outcomes. The average post-baseline scores for EQ-5D index were computed at approximately Week 12. The overall treatment comparisons were estimated at approximately Week 12.
Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy for Lymphoma (FACT-Lym) Questionnaire
FACT-Lym is a questionnaire that begins with 27 items covering four core Health-Related Quality of Life subscales: Physical Well-being (7 items), Social/Family Well-being (7), Emotional Well-being (6), and Functional Well-being (7). The FACT-Lym also includes an additional concerns subscale (15 items). It also asks participants about their concerns about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. The participants were requested to circle one number on a 0 to 4 points scale per line to indicate how true each statement has been for him/her during the past 7 days. FACT-Lym total score, which was reported, was derived based on FACT-Lym scoring guideline (Version 4). The range of FACT-Lym total score is 0 to 168. Higher scores mean better outcomes. The average post-baseline FACT-Lym total scores were computed at approximately Week 12. The overall treatment comparisons were estimated at approximately Week 12.

Full Information

First Posted
October 27, 2010
Last Updated
December 19, 2018
Sponsor
Pfizer
Collaborators
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01232556
Brief Title
A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
Official Title
AN OPEN-LABEL, RANDOMIZED, PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN ADMINISTERED IN COMBINATION WITH RITUXIMAB COMPARED TO DEFINED INVESTIGATOR'S CHOICE THERAPY IN SUBJECTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE AGGRESSIVE NON-HODGKIN LYMPHOMA WHO ARE NOT CANDIDATES FOR INTENSIVE HIGH-DOSE CHEMOTHERAPY
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated prematurely on May 16, 2013, for futility. No new or unexpected safety issues were identified.
Study Start Date
April 4, 2011 (Actual)
Primary Completion Date
March 28, 2014 (Actual)
Study Completion Date
March 28, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
UCB Pharma

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of this combination compared with an active comparator arm (investigator's choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
Keywords
inotuzumab ozogamicin, aggressive Non-Hodgkin lymphoma, diffuse large b-cell lymphoma, relapsed/refractory lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
338 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Inotuzumab ozogamicin+rituximab
Arm Title
2
Arm Type
Active Comparator
Arm Description
Investigator's choice of (1) rituximab+gemcitabine, or (2) rituximab+bendamustine
Intervention Type
Drug
Intervention Name(s)
Inotuzumab ozogamicin
Other Intervention Name(s)
CMC-544
Intervention Description
1.8 mg/m2 on day 2 every 28 days by IV infusion, 3 to 6 cycles
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles
Intervention Type
Drug
Intervention Name(s)
rituximab + gemcitabine
Intervention Description
rituximab 375 mg/m2 on days 1, 8, 15, and 22 of cycle 1, and day 1 of cycles 2 to 6, every 28 days by IV infusion, 3 to 6 cycles; gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days, 3 to 6 cycles
Intervention Type
Drug
Intervention Name(s)
rituximab +bendamustine
Intervention Description
rituximab 375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles; bendamustine 120 mg/m2 on days 1 and 2 by IV infusion every 28 days, 3 to 6 cycles
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall Survival (OS) was defined as the time from randomization to death due to any cause, censoring at the date of last contact or the end of the study. The Kaplan-Meier method was used to determine OS. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.
Time Frame
From randomization up to 5 years after last dose or up to final study visit, whichever occurs first.
Title
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)
Description
Includes all TEAEs: Any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration..
Time Frame
Up to 20 weeks after the first dose of study drug
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS is defined as time from date of randomization to date of progressive disease (PD, including investigator's claim of clinical progression), date of death from any cause, or initiation of a new treatment for the lymphoma due to persistent/refractory disease. The Kaplan-Meier method was used to determine PFS. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression. PD requires the following: Appearance of any new lesion more than 1.5 cm in any axis during or at the end of treatment, even if other lesions are decreasing in size. At least a 50% increase from nadir in the sum of the product diameters of any previously involved nodes, or in a single involved node, or the size of other lesions. At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis.
Time Frame
From randomization up to 2 years or final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
Title
Percentage of Participants With A Best Overall Response of CR or Partial Response (PR) Per NCI International Response Criteria for NHL
Description
CR is defined as disappearance of all detectable clinical evidence of disease (including cleared infiltrate on repeat bone marrow aspirate/biopsy if lymphoma involvement of bone marrow before treatment). Partial Response (PR) requires the following: ≥50 % decrease in SPD of the six largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by ≥50% in the SPD, or for single nodules, in the greatest transverse diameter. With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No new sites of disease. The 95% CI was determined using the exact method based on binomial distribution.
Time Frame
Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
Title
Percentage of Participants With A Best Overall Response of CR, Unconfirmed CR (unCR), PR, or Unconfirmed PR (unPR) Per NCI International Response Criteria for NHL
Description
CR is defined as disappearance of all detectable clinical evidence of disease (including cleared infiltrate on repeat bone marrow aspirate/biopsy if lymphoma involvement of bone marrow before treatment). Partial Response (PR) requires the following: ≥50 % decrease in SPD of the six largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by ≥50% in the SPD, or for single nodules, in the greatest transverse diameter. With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No new sites of disease. unCR and unPR means didn't have confirmatory assessment (including bone marrow assessment for CR). The 95% CI was determined using the exact method based on binomial distribution.
Time Frame
Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
Title
Duration of Response
Description
The duration of overall response is measured from the first date of response until the first date that the progressive disease (PD) or death is objectively documented. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.
Time Frame
Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
Title
Health Status as Assessed by the European Quality of Life 5 Dimension (EQ-5D) Questionnaire
Description
EQ-5D consists of a descriptive system and an EQ visual analogue scale. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The scale, the best state is marked 100 and the worst state is marked 0, is to help the participant to say how good or bad a health state is. EQ-5D index, which was reported, was derived based on US weight. The range of EQ-5D index is -0.109 to 1.00. Higher scores mean better outcomes. The average post-baseline scores for EQ-5D index were computed at approximately Week 12. The overall treatment comparisons were estimated at approximately Week 12.
Time Frame
Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reported
Title
Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy for Lymphoma (FACT-Lym) Questionnaire
Description
FACT-Lym is a questionnaire that begins with 27 items covering four core Health-Related Quality of Life subscales: Physical Well-being (7 items), Social/Family Well-being (7), Emotional Well-being (6), and Functional Well-being (7). The FACT-Lym also includes an additional concerns subscale (15 items). It also asks participants about their concerns about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. The participants were requested to circle one number on a 0 to 4 points scale per line to indicate how true each statement has been for him/her during the past 7 days. FACT-Lym total score, which was reported, was derived based on FACT-Lym scoring guideline (Version 4). The range of FACT-Lym total score is 0 to 168. Higher scores mean better outcomes. The average post-baseline FACT-Lym total scores were computed at approximately Week 12. The overall treatment comparisons were estimated at approximately Week 12.
Time Frame
Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reported

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Disney Family Cancer Center at Providence St Joseph Medical Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Providence St Joseph Medical Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Hematology-Oncology Medical Group of Fresno Inc
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6981
Country
United States
Facility Name
Clinical Research Unit
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Peter Morton Medical Plaza
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
UCLA Santa Monica Hematology Oncology
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Sansum Clinic
City
Solvang
State/Province
California
ZIP/Postal Code
93463
Country
United States
Facility Name
Howard University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center at Aventura
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
University Cancer Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
21st Century Oncology of Jacksonville, LLC
City
Fernandina Beach
State/Province
Florida
ZIP/Postal Code
32034
Country
United States
Facility Name
Davis Cancer Pavilion and Shands Medical Plaza
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Shands Cancer Hospital at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
UF Health Davis Cancer Pavillion and Shands Med Plaza
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
UF Health Shands Cancer Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Shands Hospital at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
UF Health Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
21st Century Oncology of Jacksonville, LLC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
21st Century Oncology of Jacksonville, LLC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Baptist Cancer Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Baptist Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
21st Century Oncology of Jacksonville, LLC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
21st Century Oncology of Jacksonville, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258
Country
United States
Facility Name
Medical Specialists Of The Palm Beaches
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Advanced Medical Specialties
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Mercy Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Mercy Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
21st Century Oncology of Jacksonville, LLC
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Georgia Regents Medical Cancer Pharmacy
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Georgia Regents University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Kootenai Cancer Center
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Kootenai Cancer Center
City
Post Falls
State/Province
Idaho
ZIP/Postal Code
083854
Country
United States
Facility Name
Decatur Memorial Hospital (DMH)
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Floyd Memorial Cancer Center of Indiana
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kansas Cancer Center and Medical Pavilion
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
University of Kentucky A.B. Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Kentucky Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Tulane University Hospital and Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute at farmington Hills
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Park Nicollet Frauenshuh Cancer Center
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University in St Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Barnes-Jewish St. Peters
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Beth Israel Medical Center;
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Beth Israel Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10011-5903
Country
United States
Facility Name
St Luke's- Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Stony Brook University Medical Center, The Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
West Chester Hospital Medical Building
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
OU Medical Center Presbyterian Professional Building
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
OU Medical Center Presbyterian Tower
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Peggy and Charles Stephenson Cancer Center (chemo & infusion)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Peggy and Charles Stephenson Cancer Center (clinic location)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Good Samaritan Hospital Corvallis
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Good Samaritan Hospital, Corvallis
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Samaritan Ambulatory Infusion Services
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Samaritan Pacific Coast Hospital
City
Newport
State/Province
Oregon
ZIP/Postal Code
97365
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Guthrie Clinic, Ltd.
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Robert Packer Hospital
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Thompson Oncology Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Thompson Oncology Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37932
Country
United States
Facility Name
Thompson Oncology Group
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37804
Country
United States
Facility Name
Thompson Oncology Group
City
Sevierville
State/Province
Tennessee
ZIP/Postal Code
37862
Country
United States
Facility Name
University Hospital - St. Paul
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
University Hospital - Zale Lipshy
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Baylor: Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Simmons Comprehensive Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Institut Jules Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Grand Hopital de Charleroi
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
H.-Hartziekenhuis Roeselare-Menen
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
St Augustinus Ziekenhuis
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Cliniques universitaires UCL de Mont-Godinne,
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
UMBAL Sveti Georgi, Klinika po hematologia
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
SBAL na Hematologichnichni Zabolyavania,CTH Sofia
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Spetsializirana Bolnitsa za Aktivno Lechenie na Hematologichni Zabolyavania, CTH Sofia
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3 M5
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke (CHUS), Hopital Fleurimont
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
University Hospital Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital Dubrava Department of Internal Medicine Division of Hematology
City
Zagreb
ZIP/Postal Code
10010
Country
Croatia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
State/Province
Czech Republic
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Département Pharmacie
City
Marseille
State/Province
Bouches-du-rhône
ZIP/Postal Code
Cedex 09 13273
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
State/Province
Cedex 09
ZIP/Postal Code
13273
Country
France
Facility Name
Hospital Universitaire Andre Mignot
City
Le Chesnay Cedex
State/Province
Yvelines
ZIP/Postal Code
78157
Country
France
Facility Name
Hopital Andre Mignot
City
Le Chesnay
State/Province
Yvelines
ZIP/Postal Code
78157
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
CHU Saint Eloi
City
Montpellier
ZIP/Postal Code
34295Cedex5
Country
France
Facility Name
Hopital du haut Leveque
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Universitaetsklinikum Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Sozialstiftung Bamberg
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Facility Name
Charite Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charite Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitaetsklinikum Mainz
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
TU Muenchen III. Medizinische Klinik
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitaetsklinik Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Egyesitett Szent Istvan es Szent Laszlo Korhaz /
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
DEOEC, Belgyogyaszati Intezet
City
Debrechen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Somongy Megyei Kaposi Mor Okato Korhaz/ Belgyogyaszati osztaly
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Kodlikeri Memorial Hospital
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431 005
Country
India
Facility Name
Sahyadri Clinical Research and Development Center
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 004
Country
India
Facility Name
OEC Record Management Company Pvt. Ltd.,
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Sahyadri Speciality Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Bon Secours Hospital
City
Cork
Country
Ireland
Facility Name
Nagoya Daini Red Cross Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4668650
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Ehime University Hospital
City
Toon-shi
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Gunma University Hospital
City
Maebashi-city
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Matsushita Memorial Hospital
City
Moriguchi
State/Province
Osaka
ZIP/Postal Code
570-8540
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Cancer Institute Hospital, Japanese Foundation For Cancer Research
City
Koto-Ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Akita University Hospital
City
Akita
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
National Kyushu Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Tokai University Hospital
City
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
University Hospital, Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Klaipeda Seamen's Hospital, Public Institution, department of Oncology
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Instituto Biomédico de Investigación A.C.
City
Aguascalientes
State/Province
Aguascalientes. Mexico
ZIP/Postal Code
20127
Country
Mexico
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej AVI Diagnostyka Obrazowa
City
Warszawa
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Klinika Nowotworow Ukladu Chlonnego
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Advanced Infusion Services
City
Catano
ZIP/Postal Code
00962
Country
Puerto Rico
Facility Name
Hospital Espanol Auxilio Mutuo de Puerto Rico Inc
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Federal State Budgetary Institution Hematology Scientific Centre of Ministry of
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Moscow State Healthcare Institution City clinical hospital S.P. Botkin
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Narodny onkologicky ustav
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
Hospital Virgen Del Rocio
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario De Salamanca
City
Salamanca
State/Province
Castille AND LION
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Clinic Universitari de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Institut Catala d'Oncologia-L'Hospitalet
City
L'Hospitalet De Llobregat (bcn)
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
La Laguna (Tenerife)
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Universitetssjukhuset
City
Linkoping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Skanes Universitetssjukhus i Lund
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Chang Gung Medical Foundation - Linkou Branch
City
Kuei-Shan Hsiang
State/Province
Taoyuan County
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital, Department of Internal Medicine
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Hematology Division Department of Medicine Faculty of Medicine Siriraj Hospital Mahidol University
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Regional Treatment and Diagnostic Hematology Center Communal Establishment
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Department of Oncology and Medical Radiology of State Institution
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
SI"Research Center for Radiation Medicine of NAMS of Ukraine"
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Barts Cancer Centre Dept Haemato-oncology St. Bartholomew's Hospital Barts Health NHS Trust
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Chemotherapy Preparative Unit St. Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Department of Medical Oncology St. Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust - Christie Hospital
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Department of Clinical Pathology Newcastle upon Tyne Hospitals NHS Foundation Trust Royal Victoria I
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Department of Clinical Biochemistry Newcastle upon Tyne Hospitals
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Northern Centre for Cancer Care
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Nottingham University Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Pathology Department Nottingham University Hospital - City Hospital Campus
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Pharmacy Nottingham University Hospital - City Hospital Campus
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Local Laboratory Nottingham University Hospital - City Hospital Campus
City
Nottingham
ZIP/Postal Code
NG51PB
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1931008&StudyName=%20A%20Study%20Of%20Inotuzumab%20Ozogamicin%20Plus%20Rituximab%20For%20Relapsed/Refractory%20Aggressive%20Non-Hodgkin%20Lymphoma%20Patients%20Who%20Are%20Not%20Candidates%20F
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy

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