AzTrials
AzTrials

Lymphoma, Large-Cell, DiffusePhase 3ORCHARRDNCT01014208

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

A Phase 3 study testing OFATUMUMAB + DHAP and RITUXIMAB + DHAP in people with Lymphoma, Large-Cell, Diffuse, run by GlaxoSmithKline at 173 sites in 26 countries.

Completed

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

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Large-Cell, Diffuse
What is being tested?
OFATUMUMAB + DHAP and RITUXIMAB + DHAP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
447 participants
Where
173 sitesin 26 countries
Study dates
Mar 2010to Nov 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

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

173 sites in 26 countries.

173 sites in 26 countries

United Kingdom23 sites

  • GSK Investigational Site

    Birmingham, B15 2TH

  • GSK Investigational Site

    Blackpool, FY3 8NR

  • GSK Investigational Site

    Bristol, BS2 8ED

  • GSK Investigational Site

    Cambridge, CB2 2XY

  • GSK Investigational Site

    Cheltenham, GL53 7AN

  • GSK Investigational Site

    Edinburgh, EH4 2XU

  • GSK Investigational Site

    Glasgow, G12 0YN

  • GSK Investigational Site

    Headington, Oxford, OX3 7LE

  • GSK Investigational Site

    Leeds, LS9 7TF

  • GSK Investigational Site

    Liverpool, L7 8XP

  • GSK Investigational Site

    London, NW1 2PG

  • GSK Investigational Site

    London, NW3 2QG

  • GSK Investigational Site

    London, SE5 9RS

  • GSK Investigational Site

    London, W12 0HS

  • GSK Investigational Site

    Manchester, M13 9WL

  • GSK Investigational Site

    Manchester, M20 4BX

  • GSK Investigational Site

    Newcastle upon Tyne, NE7 7DN

  • GSK Investigational Site

    Northwood, HA6 2RN

  • GSK Investigational Site

    Nottingham, NG5 1PB

  • GSK Investigational Site

    Sheffield, S10 2JF

  • GSK Investigational Site

    Southampton, SO16 6YD

  • GSK Investigational Site

    Whitchurch, Cardiff, CF14 2TL

  • GSK Investigational Site

    Wolverhampton, WV10 OQP

Other trials in United Kingdom

Japan20 sites

  • GSK Investigational Site

    Aichi, 466-8650

  • GSK Investigational Site

    Akita, 010-8543

  • GSK Investigational Site

    Fukuoka, 811-1395

  • GSK Investigational Site

    Hokkaido, 060-8648

  • GSK Investigational Site

    Hyōgo, 650-0047

  • GSK Investigational Site

    Ibaraki, 305-8576

  • GSK Investigational Site

    Kanagawa, 236-0004

  • GSK Investigational Site

    Kanagawa, 259-1143

  • GSK Investigational Site

    Kyoto, 602-8566

  • GSK Investigational Site

    Miyagi, 980-8574

  • GSK Investigational Site

    Nagano, 390-8621

  • GSK Investigational Site

    Nagasaki, 852-8501

  • GSK Investigational Site

    Okayama, 700-8558

  • GSK Investigational Site

    Osaka, 589-8511

  • GSK Investigational Site

    Tochigi, 329-0498

  • GSK Investigational Site

    Tokushima, 770-8503

  • GSK Investigational Site

    Tokyo, 104-0045

  • GSK Investigational Site

    Tokyo, 113-8655

  • GSK Investigational Site

    Tokyo, 135-8550

  • GSK Investigational Site

    Tokyo, 162-8655

Other trials in Japan

China19 sites

  • GSK Investigational Site

    Beijing, 100021

  • GSK Investigational Site

    Beijing, 100044

  • GSK Investigational Site

    Beijing, 100071

  • GSK Investigational Site

    Beijing, 100142

  • GSK Investigational Site

    Beijing, 100191

  • GSK Investigational Site

    Beijing, 100730

  • GSK Investigational Site

    Beijing, 100853

  • GSK Investigational Site

    Chengdu, 610041

  • GSK Investigational Site

    Fuzhou, Fujian, 350014

  • GSK Investigational Site

    Guangzhou, Guangdong, 510060

  • GSK Investigational Site

    Guangzhou, Guangdong, 510080

  • GSK Investigational Site

    Guangzhou, Guangdong, 510515

  • GSK Investigational Site

    Hangzhou, Zhejiang, 310003

  • GSK Investigational Site

    Jianan, Shandong, 250012

  • GSK Investigational Site

    Jiang Su Province, 215006

  • GSK Investigational Site

    Nanjing, Jiangsu, 210029

  • GSK Investigational Site

    Shanghai, 200025

  • GSK Investigational Site

    Shanghai, 200032

  • GSK Investigational Site

    Tianjin, 300020

Other trials in China

Netherlands18 sites

  • GSK Investigational Site

    Amersfoort, 3818 ES

  • GSK Investigational Site

    Amsterdam, 1066 CX

  • GSK Investigational Site

    Amsterdam, 1081 HV

  • GSK Investigational Site

    Amsterdam, 1105 AZ

  • GSK Investigational Site

    Enschede, 7511JX

  • GSK Investigational Site

    Groningen, 9713 GZ

  • GSK Investigational Site

    Hoofddorp, 2134 TM

  • GSK Investigational Site

    Leiden, 2333 ZA

  • GSK Investigational Site

    Maastricht, 6229 HX

  • GSK Investigational Site

    Nieuwegein, 3435 CM

  • GSK Investigational Site

    Nijmegen, 6525 GA

  • GSK Investigational Site

    Rotterdam, 3015 CE

  • GSK Investigational Site

    Rotterdam, 3075 EA

  • GSK Investigational Site

    Rotterdam, 3079 DZ

  • GSK Investigational Site

    Sittard-geleen, 6162 BG

  • GSK Investigational Site

    The Hague, 2545 CH

  • GSK Investigational Site

    Utrecht, 3584 CX

  • GSK Investigational Site

    Zwolle, 8025 AB

Other trials in Netherlands

United States16 sites

  • GSK Investigational Site

    Chaple Hill, North Carolina, 27599-7305

  • GSK Investigational Site

    Charleston, South Carolina, 29425

  • GSK Investigational Site

    Chicago, Illinois, 60612-7323

  • GSK Investigational Site

    Chicago, Illinois, 60637

  • GSK Investigational Site

    Greenville, South Carolina, 29601

  • GSK Investigational Site

    Jackson, Mississippi, 39216-4505

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    New Haven, Connecticut, 06520

  • GSK Investigational Site

    New York, New York, 10065

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19140

  • GSK Investigational Site

    Providence, Rhode Island, 02908

  • GSK Investigational Site

    Sacramento, California, 95816

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    Seattle, Washington, 98108

  • GSK Investigational Site

    Syracuse, New York, 13210

  • GSK Investigational Site

    Westwood, Kansas, 66205

Other trials in United States

Spain10 sites

  • GSK Investigational Site

    Barcelona, 08041

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28008

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Majadahonda (Madrid), 28222

  • GSK Investigational Site

    Murcia, 30120

  • GSK Investigational Site

    Pamplona, 31008

  • GSK Investigational Site

    Pozuelo de Alarcón/Madrid, 28223

  • GSK Investigational Site

    Salamanca, 37007

Other trials in Spain

Austria7 sites

  • GSK Investigational Site

    Graz, 8036

  • GSK Investigational Site

    Innsbruck, 6020

  • GSK Investigational Site

    Linz, 4020

  • GSK Investigational Site

    Linz, 4021

  • GSK Investigational Site

    Salzburg, A-5020

  • GSK Investigational Site

    Vienna, 1090

  • GSK Investigational Site

    Vienna, 1140

Other trials in Austria

Hungary7 sites

  • GSK Investigational Site

    Budapest, 1097

  • GSK Investigational Site

    Budapest, 1122

  • GSK Investigational Site

    Debrecen, 4012

  • GSK Investigational Site

    Győr, 9023

  • GSK Investigational Site

    Kaposvár, 7400

  • GSK Investigational Site

    Szeged, 6720

  • GSK Investigational Site

    Szombathely, 9700

Other trials in Hungary

Belgium6 sites

  • GSK Investigational Site

    Bruges, 8000

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Hasselt, 3500

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Yvoir, 5530

Other trials in Belgium

Poland6 sites

  • GSK Investigational Site

    Chorzów, 41-500

  • GSK Investigational Site

    Gdansk, 80-952

  • GSK Investigational Site

    Poznan, 60-833

  • GSK Investigational Site

    Warsaw, 02-776

  • GSK Investigational Site

    Warsaw, 02-781

  • GSK Investigational Site

    Wroclaw, 50-367

Other trials in Poland

Germany4 sites

  • GSK Investigational Site

    Aachen, North Rhine-Westphalia, 52074

  • GSK Investigational Site

    Berlin, State of Berlin, 13353

  • GSK Investigational Site

    Münster, North Rhine-Westphalia, 48149

  • GSK Investigational Site

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Sweden4 sites

  • GSK Investigational Site

    Gothenburg

  • GSK Investigational Site

    Lund, SE-221 85

  • GSK Investigational Site

    Stockholm, SE-141 86

  • GSK Investigational Site

    Uppsala, SE-751 85

Other trials in Sweden

Argentina3 sites

  • GSK Investigational Site

    Capital Federal, Buenos Aires, C1426ANZ

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO

  • GSK Investigational Site

    La Plata, Buenos Aires, B1900AXI

Other trials in Argentina

Finland3 sites

  • GSK Investigational Site

    Helsinki, 00029

  • GSK Investigational Site

    Oulu, 90029

  • GSK Investigational Site

    Tampere, 33520

Other trials in Finland

India3 sites

  • GSK Investigational Site

    Ludhiana, 141008

  • GSK Investigational Site

    Pune, 411001

  • GSK Investigational Site

    Vellore, 632004

Other trials in India

Ireland3 sites

  • GSK Investigational Site

    Dublin, 4

  • GSK Investigational Site

    Galway

  • GSK Investigational Site

    James Street, 8

Other trials in Ireland

Russia3 sites

  • GSK Investigational Site

    Moscow, 125101

  • GSK Investigational Site

    Saint Petersburg, 197022

  • GSK Investigational Site

    Saint Petersburg, 197110

Other trials in Russia

South Korea3 sites

  • GSK Investigational Site

    Jellanamdo, 519-809

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Seoul, 135-710

Other trials in South Korea

Thailand3 sites

  • GSK Investigational Site

    Bangkok, 10330

  • GSK Investigational Site

    Bangkok, 10400

  • GSK Investigational Site

    Bangkok, 10700

Other trials in Thailand

Czechia2 sites

  • GSK Investigational Site

    Brno, 625 00

  • GSK Investigational Site

    Hradec Králové

Other trials in Czechia

Denmark2 sites

  • GSK Investigational Site

    Aarhus, 8000 C

  • GSK Investigational Site

    Copenhagen, 2100

Other trials in Denmark

Estonia2 sites

  • GSK Investigational Site

    Tallinn, 13419

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

Greece2 sites

  • GSK Investigational Site

    Athens, 11 527

  • GSK Investigational Site

    Athens, 11525

Other trials in Greece

Israel2 sites

  • GSK Investigational Site

    Petah Tikva, 49100

  • GSK Investigational Site

    Ramat Gan, 52621

Other trials in Israel

Norway1 site

  • GSK Investigational Site

    Oslo, 0310

Other trials in Norway

Singapore1 site

  • GSK Investigational Site

    Singapore, 119074

Other trials in Singapore

About this study

Official title: Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant (ASCT) in Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

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.

Read the 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.

Being tested
OFATUMUMAB + DHAP, RITUXIMAB + DHAP
Keywords
The All Ireland Cooperative Oncology Research Group, GELTAMO, National Cancer Research Institute Lymphoma Clinical Studies Group, Genmab, ofatumumab, Japan Clinical Oncology Group, Oncology, Polish Lymphoma Research Group, Salvage chemotherapy, refractory, HOVON, DVD, relapsed, safety, efficacy, DHAP, rituximab, Autologous Stem Cell Transplant, Dutch-Belgian Cooperative Trial Group for Hematology-Oncology, Grupo Espanol de Linfomas
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Neoplasms, Recurrence

What participants receive

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

  • OFATUMUMAB + DHAPDrug

    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.

  • RITUXIMAB + DHAPDrug

    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.

Study groups in NCT01014208
Study groupRoleWhat they receive
OFATUMUMAB + DHAP CHEMOTHERAPY REGIMENExperimentalThis 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.
Receives: Drug: OFATUMUMAB + DHAP
RITUXIMAB + DHAP CHEMOTHERAPY REGIMENActive comparatorThis 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.
Receives: Drug: RITUXIMAB + DHAP

What is being measured

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

  1. Progression-free Survival as Assessed by Independent Reviewers

    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 via the Revised Response Criteria for Malignant Lymphoma (RRCML).

    Measured: From randomization until the date of stable disease after two cycles of salvage chemotherapy, progression, or death (assessed for up to 5 years)

Secondary outcomes (10)

  1. Number of Participants With Overall Response (OR) and Complete Response (CR) After Salvage Chemoimmunotherapy

    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.

    Measured: At completion of up to 3 cycles of salvage chemoimmunotherapy (assessed up to 9 weeks)

  2. Number of Participants With Overall Response (OR) and Complete Response (CR) Three Months After Autologous Stem Cell Transplant

    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.

    Measured: At 3 months after completion of autologous stem cell transplantation (ASCT) (assessed up to 6 months)

  3. Event-free Survival

    Event-free survival is defined as the time from randomization to progressive disease (PD; disease whose course is 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 via the Revised Response Criteria for Malignant Lymphoma (RRCML).

    Measured: 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)

  4. Overall Survival (OS)

    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.

    Measured: From randomization to death due to any cause (assessed for up to 5 years)

  5. Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram From Peripheral Blood

    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 harvest, following the administration of rituximab or ofatumumab in combination with DHAP combination chemotherapy, were assessed. The number of participants with adequate harvest of CD34+ stem cells (at least 2*10^6 CD34+ cells/kg) after dosing of salvage therapy in Cycle 2 and Cycle 3 was analyzed.

    Measured: During Cycles 2 and/or 3 (Weeks 4-9)

  6. Number of Participants Completing Autologous Stem Cell Transplant (ASCT)

    The number of participants who completed ASCT is reported.

    Measured: Approximately 4 to 6 weeks following Cycle 3 (assessed up to 3 months)

  7. Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) During Treatment

    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.

    Measured: Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months])

  8. Change From Baseline in the Functional Assessment of Cancer Therapy Lymphoma Trial Outcome Index (FACT-Lym TOI) Total Score During Treatment

    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.

    Measured: Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months])

  9. Time to Neutrophil and Platelet Recovery After Each Cycle of Salvage Chemotherapy

    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 the nadir 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.

    Measured: 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)

  10. Time to Engraftment After High-dose Therapy (HDT)/ASCT

    Engraftment is defined as 1) three consecutive days when the ANC is ≥0.5x109/L and 2) an unsupported platelet count of ≥20x109/L, and the engraftment date is the date that this occurs. 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.

    Measured: From ASCT up to 42 days post-ASCT (Baseline up to approximately 4.5 months)

Timeline

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

  1. First posted16 Nov 2009 (estimated)
  2. Study startMar 2010
  3. Primary completionFeb 2014
  4. Study completionNov 2014

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
447 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01014208
Sponsor's protocol ID
110928
Acronym
ORCHARRD
Status last verified
Feb 2015
First submitted
4 Nov 2009
Last updated
7 Aug 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OFATUMUMAB + DHAP and RITUXIMAB + DHAP in people with Lymphoma, Large-Cell, Diffuse, run by GlaxoSmithKline at 173 sites in 26 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 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 173 sites in United Kingdom, Japan, China, Netherlands, United States and 21 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 16 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival 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)). 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 NCT01014208.

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 7 Aug 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in