AzTrials
AzTrials

Lymphoma, Non-HodgkinPhase 3NCT01232556

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

A Phase 3 study testing Inotuzumab ozogamicin, Rituximab and rituximab + gemcitabine in people with Lymphoma, Non-Hodgkin, run by Pfizer at 177 sites in 25 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Non-Hodgkin
What is being tested?
Inotuzumab ozogamicin, Rituximab and rituximab + gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
338 participants
Where
177 sitesin 25 countries
Study dates
4 Apr 2011to 28 Mar 2014
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

  • -

Who cannot join

  • -

Trial locations and contacts

177 sites in 25 countries.

177 sites in 25 countries

United States82 sites

  • Georgia Regents Medical Cancer Pharmacy

    Augusta, Georgia, 30912

  • Georgia Regents University

    Augusta, Georgia, 30912

  • Mount Sinai Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

  • University Cancer Institute

    Boynton Beach, Florida, 33426

  • Disney Family Cancer Center at Providence St Joseph Medical Center

    Burbank, California, 91505

  • Providence St Joseph Medical Center

    Burbank, California, 91505

  • University Hospital

    Cincinnati, Ohio, 45219

  • Barnes-Jewish St. Peters

    City of Saint Peters, Missouri, 63376

  • Kootenai Cancer Center

    Coeur d'Alene, Idaho, 83814

  • Good Samaritan Hospital Corvallis

    Corvallis, Oregon, 97330

  • Good Samaritan Hospital, Corvallis

    Corvallis, Oregon, 97330

  • Samaritan Ambulatory Infusion Services

    Corvallis, Oregon, 97330

  • University Hospital - St. Paul

    Dallas, Texas, 75235

  • University Hospital - Zale Lipshy

    Dallas, Texas, 75235

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Baylor: Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Simmons Comprehensive Cancer Center

    Dallas, Texas, 75390

  • Decatur Memorial Hospital (DMH)

    Decatur, Illinois, 62526

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Barbara Ann Karmanos Cancer Institute at farmington Hills

    Farmington Hills, Michigan, 48334

  • 21st Century Oncology of Jacksonville, LLC

    Fernandina Beach, Florida, 32034

  • Hematology-Oncology Medical Group of Fresno Inc

    Fresno, California, 93720

  • Davis Cancer Pavilion and Shands Medical Plaza

    Gainesville, Florida, 32608

  • Shands Cancer Hospital at the University of Florida

    Gainesville, Florida, 32608

  • UF Health Davis Cancer Pavillion and Shands Med Plaza

    Gainesville, Florida, 32608

  • UF Health Shands Cancer Hospital

    Gainesville, Florida, 32608

  • Shands Hospital at the University of Florida

    Gainesville, Florida, 32610

  • UF Health Shands Hospital

    Gainesville, Florida, 32610

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • 21st Century Oncology of Jacksonville, LLC

    Jacksonville, Florida, 32205

  • 21st Century Oncology of Jacksonville, LLC

    Jacksonville, Florida, 32207

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • Baptist Medical Center

    Jacksonville, Florida, 32207

  • 21st Century Oncology of Jacksonville, LLC

    Jacksonville, Florida, 32256

  • 21st Century Oncology of Jacksonville, Inc.

    Jacksonville, Florida, 32258

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Thompson Oncology Group

    Knoxville, Tennessee, 37916

  • Thompson Oncology Group

    Knoxville, Tennessee, 37932

  • Medical Specialists Of The Palm Beaches

    Lake Worth, Florida, 33467

  • University of Kentucky A.B. Chandler Medical Center

    Lexington, Kentucky, 40536

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky, 40536

  • Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68510

  • Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services

    Los Angeles, California, 90095-6981

  • Clinical Research Unit

    Los Angeles, California, 90095

  • Peter Morton Medical Plaza

    Los Angeles, California, 90095

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • Thompson Oncology Group

    Maryville, Tennessee, 37804

  • Advanced Medical Specialties

    Miami, Florida, 33133

  • Mercy Hospital

    Miami, Florida, 33133

  • Mercy Research Institute

    Miami, Florida, 33133

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Floyd Memorial Cancer Center of Indiana

    New Albany, Indiana, 47150

  • Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112

  • Beth Israel Medical Center;

    New York, New York, 10003

  • Beth Israel Comprehensive Cancer Center

    New York, New York, 10011-5903

  • St Luke's- Roosevelt Hospital Center

    New York, New York, 10019

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Samaritan Pacific Coast Hospital

    Newport, Oregon, 97365

  • OU Medical Center Presbyterian Professional Building

    Oklahoma City, Oklahoma, 73104

  • OU Medical Center Presbyterian Tower

    Oklahoma City, Oklahoma, 73104

  • Peggy and Charles Stephenson Cancer Center (chemo & infusion)

    Oklahoma City, Oklahoma, 73104

  • Peggy and Charles Stephenson Cancer Center (clinic location)

    Oklahoma City, Oklahoma, 73104

  • 21st Century Oncology of Jacksonville, LLC

    Orange Park, Florida, 32073

  • Kootenai Cancer Center

    Post Falls, Idaho, 083854

  • Park Nicollet Frauenshuh Cancer Center

    Saint Louis Park, Minnesota, 55426

  • Sansum Clinic

    Santa Barbara, California, 93105

  • UCLA Santa Monica Hematology Oncology

    Santa Monica, California, 90404

  • Guthrie Clinic, Ltd.

    Sayre, Pennsylvania, 18840

  • Robert Packer Hospital

    Sayre, Pennsylvania, 18840

  • Thompson Oncology Group

    Sevierville, Tennessee, 37862

  • Sansum Clinic

    Solvang, California, 93463

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Washington University in St Louis

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Washington University

    St Louis, Missouri, 63110

  • Stony Brook University Medical Center, The Cancer Center

    Stony Brook, New York, 11794

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Howard University Hospital

    Washington D.C., District of Columbia, 20060

  • West Chester Hospital Medical Building

    West Chester, Ohio, 45069

  • University of Kansas Cancer Center and Medical Pavilion

    Westwood, Kansas, 66205

Other trials in United States

Japan13 sites

  • Akita University Hospital

    Akita, 010-8543

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • National Kyushu Cancer Center

    Fukuoka, 811-1395

  • Tokai University Hospital

    Kanagawa, 259-1193

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Cancer Institute Hospital, Japanese Foundation For Cancer Research

    Koto-Ku, Tokyo, 135-8550

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

  • Matsushita Memorial Hospital

    Moriguchi, Osaka, 570-8540

  • Nagoya Daini Red Cross Hospital

    Nagoya, Aichi-ken, 4668650

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

  • Ehime University Hospital

    Toon-shi, Ehime, 791-0295

Other trials in Japan

United Kingdom12 sites

  • Barts Cancer Centre Dept Haemato-oncology St. Bartholomew's Hospital Barts Health NHS Trust

    London, EC1A 7BE

  • Chemotherapy Preparative Unit St. Bartholomew's Hospital

    London, EC1A 7BE

  • Department of Medical Oncology St. Bartholomew's Hospital

    London, EC1A 7BE

  • The Christie NHS Foundation Trust - Christie Hospital

    Manchester, M20 4BX

  • Department of Clinical Pathology Newcastle upon Tyne Hospitals NHS Foundation Trust Royal Victoria I

    Newcastle upon Tyne, NE1 4LP

  • Department of Clinical Biochemistry Newcastle upon Tyne Hospitals

    Newcastle upon Tyne, NE7 7DN

  • Northern Centre for Cancer Care

    Newcastle upon Tyne, NE7 7DN

  • Nottingham University Hospital

    Nottingham, NG5 1PB

  • Pathology Department Nottingham University Hospital - City Hospital Campus

    Nottingham, NG5 1PB

  • Pharmacy Nottingham University Hospital - City Hospital Campus

    Nottingham, NG5 1PB

  • Local Laboratory Nottingham University Hospital - City Hospital Campus

    Nottingham, NG51PB

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

France8 sites

  • Hopital Andre Mignot

    Le Chesnay, Yvelines, 78157

  • Hospital Universitaire Andre Mignot

    Le Chesnay, Yvelines, 78157

  • Centre Leon Berard

    Lyon, 69373

  • Département Pharmacie

    Marseille, Bouches-du-rhône, Cedex 09 13273

  • Institut Paoli Calmettes

    Marseille, Cedex 09, 13273

  • CHU Saint Eloi

    Montpellier, 34295Cedex5

  • Hopital du haut Leveque

    Pessac, 33600

  • Centre Henri Becquerel

    Rouen, 76038

Other trials in France

Germany7 sites

  • Universitaetsklinikum Aachen

    Aachen, 52074

  • Sozialstiftung Bamberg

    Bamberg, 96049

  • Charite Campus Benjamin Franklin

    Berlin, 10117

  • Charite Campus Virchow-Klinikum

    Berlin, 13353

  • Universitaetsklinikum Mainz

    Mainz, 55101

  • TU Muenchen III. Medizinische Klinik

    München, 81675

  • Universitaetsklinik Ulm

    Ulm, 89081

Other trials in Germany

Spain7 sites

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Clinic Universitari de Barcelona

    Barcelona, 08036

  • Institut Catala d'Oncologia-L'Hospitalet

    L'Hospitalet de Llobregat (bcn), 08907

  • Hospital Universitario de Canarias

    La Laguna (Tenerife), 38320

  • Hospital de la Princesa

    Madrid, 28006

  • Hospital Universitario De Salamanca

    Salamanca, Castille and LION, 37007

  • Hospital Virgen Del Rocio

    Seville, Andalusia, 41013

Other trials in Spain

Belgium6 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Grand Hopital de Charleroi

    Charleroi, 6000

  • Universitaire Ziekenhuizen Leuven

    Leuven, Vlaams Brabant, 3000

  • H.-Hartziekenhuis Roeselare-Menen

    Roeselare, 8800

  • St Augustinus Ziekenhuis

    Wilrijk, 2610

  • Cliniques universitaires UCL de Mont-Godinne,

    Yvoir, 5530

Other trials in Belgium

Canada4 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Centre Hospitalier Universitaire de Sherbrooke (CHUS), Hopital Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3 M5

Other trials in Canada

India4 sites

  • Kodlikeri Memorial Hospital

    Chhatrapati Sambhajinagar, Maharashtra, 431 005

  • Sahyadri Clinical Research and Development Center

    Pune, Maharashtra, 411 004

  • OEC Record Management Company Pvt. Ltd.,

    Pune, Maharashtra, 411004

  • Sahyadri Speciality Hospital

    Pune, Maharashtra, 411004

Other trials in India

Taiwan4 sites

  • Chang Gung Medical Foundation - Linkou Branch

    Kuei-Shan Hsiang, Taoyuan County, 333

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital, Department of Internal Medicine

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Bulgaria3 sites

  • UMBAL Sveti Georgi, Klinika po hematologia

    Plovdiv, 4002

  • SBAL na Hematologichnichni Zabolyavania,CTH Sofia

    Sofia, 1756

  • Spetsializirana Bolnitsa za Aktivno Lechenie na Hematologichni Zabolyavania, CTH Sofia

    Sofia, 1756

Other trials in Bulgaria

Hungary3 sites

  • Egyesitett Szent Istvan es Szent Laszlo Korhaz /

    Budapest, 1097

  • DEOEC, Belgyogyaszati Intezet

    Debrechen, 4032

  • Somongy Megyei Kaposi Mor Okato Korhaz/ Belgyogyaszati osztaly

    Kaposvár, 7400

Other trials in Hungary

Russia3 sites

  • Federal State Budgetary Institution Hematology Scientific Centre of Ministry of

    Moscow, 125167

  • Moscow State Healthcare Institution City clinical hospital S.P. Botkin

    Moscow, 125284

  • Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva

    Saint Petersburg, 197022

Other trials in Russia

Ukraine3 sites

  • Regional Treatment and Diagnostic Hematology Center Communal Establishment

    Cherkasy, 18009

  • Department of Oncology and Medical Radiology of State Institution

    Dnipropetrovsk, 49102

  • SI"Research Center for Radiation Medicine of NAMS of Ukraine"

    Kyiv, 03115

Other trials in Ukraine

Croatia2 sites

  • University Hospital Zagreb

    Zagreb, 10000

  • University Hospital Dubrava Department of Internal Medicine Division of Hematology

    Zagreb, 10010

Other trials in Croatia

Czechia2 sites

  • Fakultni nemocnice Brno

    Brno, 62500

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, Czech Republic, 100 34

Other trials in Czechia

Poland2 sites

  • Niepubliczny Zaklad Opieki Zdrowotnej AVI Diagnostyka Obrazowa

    Warsaw, 00-728

  • Klinika Nowotworow Ukladu Chlonnego

    Warsaw, 02-781

Other trials in Poland

Puerto Rico2 sites

  • Advanced Infusion Services

    Catano, 00962

  • Hospital Espanol Auxilio Mutuo de Puerto Rico Inc

    San Juan, 00918

Other trials in Puerto Rico

Singapore2 sites

  • National University Hospital

    Singapore, 119074

  • Singapore General Hospital

    Singapore, 169608

Other trials in Singapore

Sweden2 sites

  • Universitetssjukhuset

    Linköping, 58185

  • Skanes Universitetssjukhus i Lund

    Lund, 221 85

Other trials in Sweden

Thailand2 sites

  • Hematology Division Department of Medicine Faculty of Medicine Siriraj Hospital Mahidol University

    Bangkoknoi, Bangkok, 10700

  • Chiang Mai University

    Chiang Mai, 50200

Other trials in Thailand

Ireland1 site

  • Bon Secours Hospital

    Cork

Other trials in Ireland

Lithuania1 site

  • Klaipeda Seamen's Hospital, Public Institution, department of Oncology

    Klaipėda, 92288

Other trials in Lithuania

Mexico1 site

  • Instituto Biomédico de Investigación A.C.

    Aguascalientes, Aguascalientes. Mexico, 20127

Other trials in Mexico

Slovakia1 site

  • Narodny onkologicky ustav

    Bratislava, 833 10

Other trials in Slovakia

About this study

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

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.

Being tested
Inotuzumab ozogamicin, Rituximab, rituximab + gemcitabine, rituximab +bendamustine
Keywords
inotuzumab ozogamicin, aggressive Non-Hodgkin lymphoma, diffuse large b-cell lymphoma, relapsed/refractory lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma

What participants receive

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

  • Inotuzumab ozogamicinDrug

    Also called CMC-544

    1.8 mg/m2 on day 2 every 28 days by IV infusion, 3 to 6 cycles

  • RituximabDrug

    375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles

  • rituximab + gemcitabineDrug

    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

  • rituximab +bendamustineDrug

    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

Study groups in NCT01232556
Study groupRoleWhat they receive
1ExperimentalInotuzumab ozogamicin+rituximab
Receives: Drug: Inotuzumab ozogamicin; Drug: Rituximab
2Active comparatorInvestigator's choice of (1) rituximab+gemcitabine, or (2) rituximab+bendamustine
Receives: Drug: rituximab + gemcitabine; Drug: rituximab +bendamustine

What is being measured

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

  1. 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.

    Measured: From randomization up to 5 years after last dose or up to final study visit, whichever occurs first.

  2. 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..

    Measured: Up to 20 weeks after the first dose of study drug

Secondary outcomes (6)

  1. 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:

    1. 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.
    2. 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.
    3. At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis.

    Measured: 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.

  2. 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:

    1. ≥50 % decrease in SPD of the six largest dominant nodes or nodal masses.
    2. No increase in the size of other nodes, liver, or spleen.
    3. Splenic and hepatic nodules must regress by ≥50% in the SPD, or for single nodules, in the greatest transverse diameter.
    4. With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.
    5. No new sites of disease. The 95% CI was determined using the exact method based on binomial distribution.

    Measured: 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.

  3. 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:

    1. ≥50 % decrease in SPD of the six largest dominant nodes or nodal masses.
    2. No increase in the size of other nodes, liver, or spleen.
    3. Splenic and hepatic nodules must regress by ≥50% in the SPD, or for single nodules, in the greatest transverse diameter.
    4. With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.
    5. 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.

    Measured: 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.

  4. 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.

    Measured: 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.

  5. 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.

    Measured: Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reported

  6. 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.

    Measured: Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reported

Timeline

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

  1. First posted2 Nov 2010 (estimated)
  2. Study start4 Apr 2011
  3. Primary completion28 Mar 2014
  4. Study completion28 Mar 2014

Why it stopped: The study was terminated prematurely on May 16, 2013, for futility. No new or unexpected safety issues were identified.

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
None (open label)
Enrolment
338 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01232556
Sponsor's protocol ID
B1931008
Other IDs
3129K5-3303, 2010-020147-12
Status last verified
Dec 2018
First submitted
27 Oct 2010
Last updated
8 Jan 2019
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inotuzumab ozogamicin, Rituximab and rituximab + gemcitabine in people with Lymphoma, Non-Hodgkin, run by Pfizer at 177 sites in 25 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 sites in United States, Japan, United Kingdom, France, Germany and 20 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 21 Aug 2018). 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?

Overall Survival (time frame: From randomization up to 5 years after last dose or up to final study visit, whichever occurs first.). The study lists 2 primary outcomes in all. 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 NCT01232556.

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 8 Jan 2019.

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