Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma (ORCHARRD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01014208
First received: November 4, 2009
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

This study is being conducted to compare the efficacy and safety of ofatumumab in addition to salvage chemotherapy versus rituximab in addition to salvage chemotherapy in CD20 positive DLBCL subjects relapsing, or with persistent disease, after first-line treatment with rituximab combined with an anthracycline-based chemotherapy regimen and be eligible for ASCT.


Condition Intervention Phase
Lymphoma, Large-Cell, Diffuse
Drug: OFATUMUMAB + DHAP
Drug: RITUXIMAB + DHAP
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant (ASCT) in Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Progression-free Survival as Assessed by Independent Reviewers [ Time Frame: From randomization until the date of stable disease after two cycles of salvage chemotherapy, progression, or death (assessed for up to 5 years) ] [ Designated as safety issue: No ]
    Progression-free survival is defined as the interval of time from the randomization date until the date of stable disease (SD; failure to attain the criteria needed for a CR or PR and no fulfillment of the criteria for progressive disease [PD]) after two cycles of salvage chemotherapy, progression, or death, whichever occurs first. Disease progression was based on the assessments of independent reviewers for the disease under study. Disease progression was based on imaging data or clinical assessment data (if radiologic assessment data were not possible or assessment was not performed) via the Revised Response Criteria for Malignant Lymphoma (RRCML).


Secondary Outcome Measures:
  • Number of Participants With Overall Response (OR) and Complete Response (CR) After Salvage Chemoimmunotherapy [ Time Frame: At completion of up to 3 cycles of salvage chemoimmunotherapy (assessed up to 9 weeks) ] [ Designated as safety issue: No ]
    OR is defined as the number of participants achieving either a complete response (CR) or a partial response (PR). CR is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR is defined as at least a 50% decrease from Baseline in the sum of the product of the diameters of target lesions. RRCML was used to assess CR and PR.

  • Number of Participants With Overall Response (OR) and Complete Response (CR) Three Months After Autologous Stem Cell Transplant [ Time Frame: At 3 months after completion of autologous stem cell transplantation (ASCT) (assessed up to 6 months) ] [ Designated as safety issue: No ]
    OR is defined as the number of participants achieving either a complete response (CR) or a partial response (PR). CR is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR is defined as at least a 50% decrease from Baseline in the sum of the product of the diameters of target lesions. RRCML was used to assess CR and PR.

  • Event-free Survival [ Time Frame: From randomization to progressive disease, stable disease after completion of 2 cycles of therapy, commencement of a new treatment for DLBCL, or death due to any cause (assessed for up to 5 years) ] [ Designated as safety issue: No ]
    Event-free survival is defined as the time from randomization to progressive disease (PD; disease or physical ailment whose course in most cases is the worsening, growth, or spread of the disease), stable disease (SD; failure to attain the criteria needed for a CR or PR and no fulfillment of the criteria for PD) after completion of 2 cycles of therapy, commencement of a new treatment for diffuse large B cell lymphoma (DLBCL) (e.g., radiotherapy), or death from any cause, whichever occurs first. Disease progression was based on the assessments of independent reviewers for the disease under study. Disease progression was based on imaging data or clinical assessment data (if radiologic assessment data were not possible or assessment was not performed) via the Revised Response Criteria for Malignant Lymphoma (RRCML).

  • Overall Survival (OS) [ Time Frame: From randomization to death due to any cause (assessed for up to 5 years) ] [ Designated as safety issue: No ]
    OS is defined as the time from randomization to death due to any cause. Participants who were still alive by the end of the study were censored.

  • Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram From Peripheral Blood [ Time Frame: During Cycles 2 and/or 3 (Weeks 4-9) ] [ Designated as safety issue: No ]
    CD34+ cells are a mixture of stem cells and white blood cells of various degrees of maturity. Stem cell mobilization is the process of stimulating the hematopoietic stem cells (CD34+) to move out of the bone marrow and into the bloodstream, where they can be collected via a process called apheresis. Successful mobilization is defined as the collection of >2*10^6 CD34+ cells/kg. Only those participants who commenced mobilization, following the administration of rituximab or ofatumumab in combination with DHAP combination chemotherapy, were assessed. The number of participants with adequate harvest of autologous stem cells (at least 2*10^6 CD34+ cells/kg) after completion of salvage therapy in Cycle 2 and Cycle 3 was analyzed.

  • Number of Participants Completing Autologous Stem Cell Transplant (ASCT) [ Time Frame: Approximately 4 to 6 weeks following Cycle 3 (assessed up to 3 months) ] [ Designated as safety issue: No ]
    The number of participants who completed ASCT is reported.

  • Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) During Treatment [ Time Frame: Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months]) ] [ Designated as safety issue: No ]
    The FACT-G was developed by the Functional Assessment of Chronic Illness Therapy (FACIT) group for use in adults in a wide range of oncology clinical trial populations. The 27 items of the FACT-G are scored in the following domains: Physical Well-being (7 items), Social/Family Wellbeing (7 items), Emotional Well-being (6 items), and Functional Well-being (7 items). Participants responded to the items on a five-point Likert scale ranging from 0, "Not at all" to 4, "Very much." The total score ranges from 0 to 108; higher scores indicate a better patient-reported outcome/quality of life. Participants were asked to think back over the past week when responding to the items.

  • Change From Baseline in the Functional Assessment of Cancer Therapy Lymphoma Trial Outcome Index (FACT-Lym TOI) Total Score During Treatment [ Time Frame: Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months]) ] [ Designated as safety issue: No ]
    The FACT-Lym TOI is a measure that combines the FACT-Lym subscale (15 items; responses to each item range from 0, "Not at all" to 4, "Very much") with two domains taken from the FACT-G (responses to each item range from "Not at all " to "Very much"): Physical Well-being (7 items: lack of energy, nausea, meeting family needs, pain, side effects, feels ill, spends time in bed) and Functional Well-being (7 items: ability to work, work fulfilment, ability to enjoy life, illness acceptance, ability to sleep well, enjoying things done for fun, satisfaction with quality of life). This index is designed to be sensitive to changes in treatment regimens. The total FACT-Lym TOI score ranges from 0 to 116; higher scores indicate a better patient-reported outcome/quality of life. Participants were asked to think back over the past week when responding to the items.

  • Time to Neutrophil and Platelet Recovery After Each Cycle of Salvage Chemotherapy [ Time Frame: From the start of each cycle for a maximum of 5 weeks per cycle (assessed during treatment period of Baseline up to approximately 3 months) ] [ Designated as safety issue: No ]
    Neutrophil (absolute neutrophil count [ANC]) recovery is defined as ANC >=0.5*10^9/Liter and increasing, and platelet (PLT) recovery is defined as PLT >=10*10^9/Liter and increasing. For each cycle, time to ANC recovery is defined as the time from the first dose to the first ANC >=0.5*10^9/Liter and increasing after reaching the lowest value in the cycle. For each cycle, time to PLT recovery is defined as the time from the first dose to the first PLT >=10*10^9/L and increasing after the nadir in the cycle.

  • Time to Engraftment After High-dose Therapy (HDT)/ASCT [ Time Frame: From ASCT up to 42 days post-ASCT (Baseline up to approximately 4.5 months) ] [ Designated as safety issue: No ]
    Engraftment is defined as the time at which both neutrophil engraftment and platelet engraftment has been achieved, and the engraftment date is defined as the later of the neutrophil engraftment date and the platelet engraftment date. If engraftment was not achieved by Day 42 or the last observation, engraftment was deemed to be a failure, and censoring took place at Day 42 or at the last observation.


Enrollment: 447
Study Start Date: March 2010
Estimated Study Completion Date: November 2018
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OFATUMUMAB + DHAP CHEMOTHERAPY REGIMEN
This study is a parallel arm study, with ofatumumab + DHAP. The Investigators are required to prospectively choose to treat all of their subjects with either DHAP chemotherapy regimens in combination with ofatumumab. All subjects will receive the same ofatumumab regimen and dose.
Drug: OFATUMUMAB + DHAP
3 cycles of treatment will be administered. Each cycle will last 21 days. ofatumumab dose: cycle 1, day 1 - 1000 mg; cycle 1, day 8 - 1000 mg; cycle 2, day 1 and cycle 3, day 1 - 1000 mg. DHAP regimen: dexamethasone - 40 mg on days 1, 2, 3, and 4 of dosing cycle; cisplatin - 100 mg/m2/24hrs continuous on day 1 of dosing cycle; cytarabine - 2g/m2 q12 hrs (2 doses) on day 2 of dosing cycle.
Active Comparator: RITUXIMAB + DHAP CHEMOTHERAPY REGIMEN
This study is a parallel arm study, with rituximab + DHAP. The Investigators are required to prospectively choose to treat all of their subjects with either DHAP chemotherapy regimens in combination with rituximab. All subjects will receive the same rituximab regimen and dose.
Drug: RITUXIMAB + DHAP
3 cycles of treatment will be administered. Each cycle will last 21 days. rituximab dose: cycle 1, day 1 - 375 mg/m2; cycle 1, day 8 - 375 mg/m2; cycle 2, day 1 and cycle 3, day 1 - 375 mg/m2. DHAP regimen: dexamethasone - 40 mg on days 1, 2, 3, and 4 of dosing cycle; cisplatin - 100 mg/m2/24hrs continuous on day 1 of dosing cycle; cytarabine - 2g/m2 q12 hrs (2 doses) on day 2 of dosing cycle.

Detailed Description:

As rituximab-based regimens have become standard first-line treatment in CD20 positive DLBCL, the efficacy of rituximab combined with salvage chemotherapy in the second-line setting has decreased and there is a need for new therapies in patients progressing or relapsing after first-line rituximab-based therapy. Replacement of rituximab with ofatumumab in the second-line setting, following progression/relapse after first-line rituximab-containing regimens, offers the potential to overcome relative or complete rituximab resistance and thus improve response rates, the ability to proceed to consolidative HDT/ASCT, and overall survival.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with CD20 positive DLBCL or grade 3b follicular lymphoma (FL) at original diagnosis.
  • Refractory to, or relapsed following, first-line treatment with rituximab combined with anthracycline- or anthracenedione-based chemotherapy as defined by the protocol.
  • CT with involvement of 2 or more clearly demarcated lesions/ nodes with a long axis > 1.5 cm and short axis >= 1.0cm or 1 clearly demarcated lesion/ node with a long axis > 2.0 cm and short axis >= 1.0 cm.
  • Baseline FDG-PET scans must demonstrate positive lesions compatible with CT defined anatomical tumor sites.
  • Age 18 yrs or older.
  • ECOG performance status of 0, 1 or 2.
  • Eligible for high dose chemotherapy and ASCT.
  • Resolution of toxicities from first-line therapy to a grade that in the opinion of the investigator does not contraindicate study participation.
  • Signed written informed consent.

Exclusion Criteria:

  • Previous cancer therapy for lymphoma, with the exception of first-line rituximab/ anthracycline- or anthracenedione-based chemotherapy, monotherapy rituximab prior to or combined with first-line chemotherapy, as maintenance therapy, and radiotherapy in a limited field or as a part of the first-line treatment plan.
  • Any anti-cancer therapy, except limited field radiotherapy, within 2 weeks prior to start of study therapy.
  • Planned post-randomization chronic glucocorticoid use (limited acute use is allowed and defined by the protocol) unless administered as therapy for mild COPD or asthma.
  • Clinically significant cardiac disease, active or chronic infections, serious significant diseases, other cancer within last 5 years. History of significant cerebrovascular disease.
  • Prior treatment with anti-CD20 monoclonal antibodies with the exception of rituximab.
  • Abnormal/ inadequate WBC count, liver, and kidney function.
  • Pregnant or lactating women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception during and up to 1 year following dosing completion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014208

  Hide Study Locations
Locations
United States, California
GSK Investigational Site
Sacramento, California, United States, 95816
United States, Connecticut
GSK Investigational Site
New Haven, Connecticut, United States, 06520
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60637
GSK Investigational Site
Chicago, Illinois, United States, 60612-7323
United States, Kansas
GSK Investigational Site
Westwood, Kansas, United States, 66205
United States, Mississippi
GSK Investigational Site
Jackson, Mississippi, United States, 39216-4505
United States, New York
GSK Investigational Site
New York, New York, United States, 10065
GSK Investigational Site
Syracuse, New York, United States, 13210
United States, North Carolina
GSK Investigational Site
Chaple Hill, North Carolina, United States, 27599-7305
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
United States, Rhode Island
GSK Investigational Site
Providence, Rhode Island, United States, 02908
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29425
GSK Investigational Site
Greenville, South Carolina, United States, 29601
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98108
Argentina
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, C1426ANZ
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1431FWO
GSK Investigational Site
La Plata, Buenos Aires, Argentina, B1900AXI
Austria
GSK Investigational Site
Graz, Austria, 8036
GSK Investigational Site
Innsbruck, Austria, 6020
GSK Investigational Site
Linz, Austria, 4021
GSK Investigational Site
Linz, Austria, 4020
GSK Investigational Site
Salzburg, Austria, A-5020
GSK Investigational Site
Wien, Austria, 1090
GSK Investigational Site
Wien, Austria, 1140
Belgium
GSK Investigational Site
Brugge, Belgium, 8000
GSK Investigational Site
Bruxelles, Belgium, 1200
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Hasselt, Belgium, 3500
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Yvoir, Belgium, 5530
China, Fujian
GSK Investigational Site
Fuzhou, Fujian, China, 350014
China, Guangdong
GSK Investigational Site
Guangzhou, Guangdong, China, 510515
GSK Investigational Site
Guangzhou, Guangdong, China, 510060
GSK Investigational Site
Guangzhou, Guangdong, China, 510080
China, Jiangsu
GSK Investigational Site
Nanjing, Jiangsu, China, 210029
China, Shandong
GSK Investigational Site
Jianan, Shandong, China, 250012
China, Zhejiang
GSK Investigational Site
Hangzhou, Zhejiang, China, 310003
China
GSK Investigational Site
Beijing, China, 100071
GSK Investigational Site
Beijing, China, 100021
GSK Investigational Site
Beijing, China, 100044
GSK Investigational Site
Beijing, China, 100853
GSK Investigational Site
Beijing, China, 100191
GSK Investigational Site
Beijing, China, 100142
GSK Investigational Site
Beijing, China, 100730
GSK Investigational Site
Chengdu, China, 610041
GSK Investigational Site
Jiang Su Province, China, 215006
GSK Investigational Site
Shanghai, China, 200025
GSK Investigational Site
Shanghai, China, 200032
GSK Investigational Site
Tianjin, China, 300020
Czech Republic
GSK Investigational Site
Brno, Czech Republic, 625 00
GSK Investigational Site
Hradec Kralove, Czech Republic
Denmark
GSK Investigational Site
Aarhus, Denmark, 8000 C
GSK Investigational Site
Koebenhavn, Denmark, 2100
Estonia
GSK Investigational Site
Tallinn, Estonia, 13419
GSK Investigational Site
Tartu, Estonia, 51014
Finland
GSK Investigational Site
Helsinki, Finland, 00029
GSK Investigational Site
Oulu, Finland, 90029
GSK Investigational Site
Tampere, Finland, 33520
Germany
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89081
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52074
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48149
GSK Investigational Site
Berlin, Germany, 13353
Greece
GSK Investigational Site
Athens, Greece, 11525
GSK Investigational Site
Athens, Greece, 11 527
Hungary
GSK Investigational Site
Budapest, Hungary, 1097
GSK Investigational Site
Budapest, Hungary, 1122
GSK Investigational Site
Debrecen, Hungary, 4012
GSK Investigational Site
Győr, Hungary, 9023
GSK Investigational Site
Kaposvár, Hungary, 7400
GSK Investigational Site
Szeged, Hungary, 6720
GSK Investigational Site
Szombathely, Hungary, 9700
India
GSK Investigational Site
Ludhiana, India, 141008
GSK Investigational Site
Pune, India, 411001
GSK Investigational Site
Vellore, India, 632004
Ireland
GSK Investigational Site
Dublin, Ireland, 4
GSK Investigational Site
Galway, Ireland
GSK Investigational Site
James Street, Ireland, 8
Israel
GSK Investigational Site
Petach-Tikva, Israel, 49100
GSK Investigational Site
Ramat Gan, Israel, 52621
Japan
GSK Investigational Site
Aichi, Japan, 466-8650
GSK Investigational Site
Akita, Japan, 010-8543
GSK Investigational Site
Fukuoka, Japan, 811-1395
GSK Investigational Site
Hokkaido, Japan, 060-8648
GSK Investigational Site
Hyogo, Japan, 650-0047
GSK Investigational Site
Ibaraki, Japan, 305-8576
GSK Investigational Site
Kanagawa, Japan, 236-0004
GSK Investigational Site
Kanagawa, Japan, 259-1143
GSK Investigational Site
Kyoto, Japan, 602-8566
GSK Investigational Site
Miyagi, Japan, 980-8574
GSK Investigational Site
Nagano, Japan, 390-8621
GSK Investigational Site
Nagasaki, Japan, 852-8501
GSK Investigational Site
Okayama, Japan, 700-8558
GSK Investigational Site
Osaka, Japan, 589-8511
GSK Investigational Site
Tochigi, Japan, 329-0498
GSK Investigational Site
Tokushima, Japan, 770-8503
GSK Investigational Site
Tokyo, Japan, 162-8655
GSK Investigational Site
Tokyo, Japan, 104-0045
GSK Investigational Site
Tokyo, Japan, 135-8550
GSK Investigational Site
Tokyo, Japan, 113-8655
Korea, Republic of
GSK Investigational Site
Jellanamdo, Korea, Republic of, 519-809
GSK Investigational Site
Seoul, Korea, Republic of, 120-752
GSK Investigational Site
Seoul, Korea, Republic of, 135-710
Netherlands
GSK Investigational Site
Amersfoort, Netherlands, 3818 ES
GSK Investigational Site
Amsterdam, Netherlands, 1081 HV
GSK Investigational Site
Amsterdam, Netherlands, 1066 CX
GSK Investigational Site
Amsterdam, Netherlands, 1105 AZ
GSK Investigational Site
Den Haag, Netherlands, 2545 CH
GSK Investigational Site
Enschede, Netherlands, 7511JX
GSK Investigational Site
Groningen, Netherlands, 9713 GZ
GSK Investigational Site
Hoofddorp, Netherlands, 2134 TM
GSK Investigational Site
Leiden, Netherlands, 2333 ZA
GSK Investigational Site
Maastricht, Netherlands, 6229 HX
GSK Investigational Site
Nieuwegein, Netherlands, 3435 CM
GSK Investigational Site
Nijmegen, Netherlands, 6525 GA
GSK Investigational Site
Rotterdam, Netherlands, 3079 DZ
GSK Investigational Site
Rotterdam, Netherlands, 3075 EA
GSK Investigational Site
Rotterdam, Netherlands, 3015 CE
GSK Investigational Site
Sittard-geleen, Netherlands, 6162 BG
GSK Investigational Site
Utrecht, Netherlands, 3584 CX
GSK Investigational Site
Zwolle, Netherlands, 8025 AB
Norway
GSK Investigational Site
Oslo, Norway, 0310
Poland
GSK Investigational Site
Chorzow, Poland, 41-500
GSK Investigational Site
Gdansk, Poland, 80-952
GSK Investigational Site
Poznan, Poland, 60-833
GSK Investigational Site
Warszawa, Poland, 02-781
GSK Investigational Site
Warszawa, Poland, 02-776
GSK Investigational Site
Wroclaw, Poland, 50-367
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 125101
GSK Investigational Site
St-Petersburg, Russian Federation, 197110
GSK Investigational Site
St. Petersburg, Russian Federation, 197022
Singapore
GSK Investigational Site
Singapore, Singapore, 119074
Spain
GSK Investigational Site
Barcelona, Spain, 08041
GSK Investigational Site
Madrid, Spain, 28008
GSK Investigational Site
Madrid, Spain, 28041
GSK Investigational Site
Madrid, Spain, 28007
GSK Investigational Site
Madrid, Spain, 28006
GSK Investigational Site
Majadahonda (Madrid), Spain, 28222
GSK Investigational Site
Murcia, Spain, 30120
GSK Investigational Site
Pamplona, Spain, 31008
GSK Investigational Site
Pozuelo de Alarcón/Madrid, Spain, 28223
GSK Investigational Site
Salamanca, Spain, 37007
Sweden
GSK Investigational Site
Göteborg, Sweden
GSK Investigational Site
Lund, Sweden, SE-221 85
GSK Investigational Site
Stockholm, Sweden, SE-141 86
GSK Investigational Site
Uppsala, Sweden, SE-751 85
Thailand
GSK Investigational Site
Bangkok, Thailand, 10700
GSK Investigational Site
Bangkok, Thailand, 10400
GSK Investigational Site
Bangkok, Thailand, 10330
United Kingdom
GSK Investigational Site
Birmingham, United Kingdom, B15 2TH
GSK Investigational Site
Blackpool, United Kingdom, FY3 8NR
GSK Investigational Site
Bristol, United Kingdom, BS2 8ED
GSK Investigational Site
Cambridge, United Kingdom, CB2 2XY
GSK Investigational Site
Cheltenham, United Kingdom, GL53 7AN
GSK Investigational Site
Edinburgh, United Kingdom, EH4 2XU
GSK Investigational Site
Glasgow, United Kingdom, G12 0YN
GSK Investigational Site
Headington, Oxford, United Kingdom, OX3 7LE
GSK Investigational Site
Leeds, United Kingdom, LS9 7TF
GSK Investigational Site
Liverpool, United Kingdom, L7 8XP
GSK Investigational Site
London, United Kingdom, SE5 9RS
GSK Investigational Site
London, United Kingdom, W12 0HS
GSK Investigational Site
London, United Kingdom, NW1 2PG
GSK Investigational Site
London, United Kingdom, NW3 2QG
GSK Investigational Site
Manchester, United Kingdom, M13 9WL
GSK Investigational Site
Manchester, United Kingdom, M20 4BX
GSK Investigational Site
Newcastle upon Tyne, United Kingdom, NE7 7DN
GSK Investigational Site
Northwood, United Kingdom, HA6 2RN
GSK Investigational Site
Nottingham, United Kingdom, NG5 1PB
GSK Investigational Site
Sheffield, United Kingdom, S10 2JF
GSK Investigational Site
Southampton, United Kingdom, SO16 6YD
GSK Investigational Site
Whitchurch, Cardiff, United Kingdom, CF14 2TL
GSK Investigational Site
Wolverhampton, United Kingdom, WV10 OQP
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01014208     History of Changes
Other Study ID Numbers: 110928
Study First Received: November 4, 2009
Results First Received: October 9, 2014
Last Updated: October 9, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
DVD
Polish Lymphoma Research Group
Nordic Lymphoma Group
refractory
Grupo Espanol de Linfomas
rituximab
Autologous Stem Cell Transplant
HOVON
GELTAMO
Genmab
National Cancer Research Institute Lymphoma Clinical Studies Group
DHAP
The All Ireland Cooperative Oncology Research Group
ofatumumab
Oncology
Salvage chemotherapy
relapsed
safety
efficacy
Japan Clinical Oncology Group
Dutch-Belgian Cooperative Trial Group for Hematology-Oncology

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antibodies, Monoclonal
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014