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

Primary Purpose

Lymphoma, Large-Cell, Diffuse

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

OFATUMUMAB + DHAP

RITUXIMAB + DHAP

About this trial

This is an interventional treatment trial for Lymphoma, Large-Cell, Diffuse focused on measuring 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, Nordic Lymphoma Group

Eligibility Criteria

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

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OFATUMUMAB + DHAP CHEMOTHERAPY REGIMEN

RITUXIMAB + DHAP CHEMOTHERAPY REGIMEN

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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

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).

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.

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.

Number of Participants Completing Autologous Stem Cell Transplant (ASCT)

The number of participants who completed ASCT is reported.

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.

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.

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.

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.

Full Information

NCT ID

NCT01014208

First Posted

November 4, 2009

Last Updated

July 9, 2015

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01014208

Brief Title

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

Acronym

ORCHARRD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 chemotherapy regimen and be eligible for ASCT.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Large-Cell, Diffuse

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, Nordic Lymphoma Group

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

447 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OFATUMUMAB + DHAP CHEMOTHERAPY REGIMEN

Arm Type

Experimental

Arm Description

Arm Title

RITUXIMAB + DHAP CHEMOTHERAPY REGIMEN

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

OFATUMUMAB + DHAP

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

RITUXIMAB + DHAP

Intervention Description

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.

Primary Outcome Measure Information:

Title

Progression-free Survival as Assessed by Independent Reviewers

Description

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)

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Event-free Survival

Description

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)

Title

Overall Survival (OS)

Description

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.

Time Frame

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

Title

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

Description

Time Frame

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

Title

Number of Participants Completing Autologous Stem Cell Transplant (ASCT)

Description

The number of participants who completed ASCT is reported.

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

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)

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

Facility Name

GSK Investigational Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

GSK Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612-7323

Country

United States

Facility Name

GSK Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

GSK Investigational Site

City

Westwood

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

Facility Name

GSK Investigational Site

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216-4505

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

GSK Investigational Site

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

GSK Investigational Site

City

Chaple Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7305

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

GSK Investigational Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02908

Country

United States

Facility Name

GSK Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

GSK Investigational Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29601

Country

United States

Facility Name

GSK Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

GSK Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98108

Country

United States

Facility Name

GSK Investigational Site

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

C1426ANZ

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1431FWO

Country

Argentina

Facility Name

GSK Investigational Site

City

La Plata

State/Province

Buenos Aires

ZIP/Postal Code

B1900AXI

Country

Argentina

Facility Name

GSK Investigational Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

GSK Investigational Site

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

GSK Investigational Site

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

GSK Investigational Site

City

Linz

ZIP/Postal Code

4021

Country

Austria

Facility Name

GSK Investigational Site

City

Salzburg

ZIP/Postal Code

A-5020

Country

Austria

Facility Name

GSK Investigational Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

GSK Investigational Site

City

Wien

ZIP/Postal Code

1140

Country

Austria

Facility Name

GSK Investigational Site

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

GSK Investigational Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

GSK Investigational Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

GSK Investigational Site

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

GSK Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

GSK Investigational Site

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

GSK Investigational Site

City

Fuzhou

State/Province

Fujian

ZIP/Postal Code

350014

Country

China

Facility Name

GSK Investigational Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Facility Name

GSK Investigational Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Facility Name

GSK Investigational Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

Facility Name

GSK Investigational Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

Facility Name

GSK Investigational Site

City

Jianan

State/Province

Shandong

ZIP/Postal Code

250012

Country

China

Facility Name

GSK Investigational Site

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

Facility Name

GSK Investigational Site

City

Beijing

ZIP/Postal Code

100021

Country

China

Facility Name

GSK Investigational Site

City

Beijing

ZIP/Postal Code

100044

Country

China

Facility Name

GSK Investigational Site

City

Beijing

ZIP/Postal Code

100071

Country

China

Facility Name

GSK Investigational Site

City

Beijing

ZIP/Postal Code

100142

Country

China

Facility Name

GSK Investigational Site

City

Beijing

ZIP/Postal Code

100191

Country

China

Facility Name

GSK Investigational Site

City

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

GSK Investigational Site

City

Beijing

ZIP/Postal Code

100853

Country

China

Facility Name

GSK Investigational Site

City

Chengdu

ZIP/Postal Code

610041

Country

China

Facility Name

GSK Investigational Site

City

Jiang Su Province

ZIP/Postal Code

215006

Country

China

Facility Name

GSK Investigational Site

City

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

GSK Investigational Site

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

GSK Investigational Site

City

Tianjin

ZIP/Postal Code

300020

Country

China

Facility Name

GSK Investigational Site

City

Brno

ZIP/Postal Code

625 00

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Hradec Kralove

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Aarhus

ZIP/Postal Code

8000 C

Country

Denmark

Facility Name

GSK Investigational Site

City

Koebenhavn

ZIP/Postal Code

2100

Country

Denmark

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

GSK Investigational Site

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

Facility Name

GSK Investigational Site

City

Helsinki

ZIP/Postal Code

00029

Country

Finland

Facility Name

GSK Investigational Site

City

Oulu

ZIP/Postal Code

90029

Country

Finland

Facility Name

GSK Investigational Site

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Facility Name

GSK Investigational Site

City

Ulm

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

89081

Country

Germany

Facility Name

GSK Investigational Site

City

Aachen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

52074

Country

Germany

Facility Name

GSK Investigational Site

City

Muenster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48149

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

11 527

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

11525

Country

Greece

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1097

Country

Hungary

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

GSK Investigational Site

City

Debrecen

ZIP/Postal Code

4012

Country

Hungary

Facility Name

GSK Investigational Site

City

Győr

ZIP/Postal Code

9023

Country

Hungary

Facility Name

GSK Investigational Site

City

Kaposvár

ZIP/Postal Code

7400

Country

Hungary

Facility Name

GSK Investigational Site

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

GSK Investigational Site

City

Szombathely

ZIP/Postal Code

9700

Country

Hungary

Facility Name

GSK Investigational Site

City

Ludhiana

ZIP/Postal Code

141008

Country

India

Facility Name

GSK Investigational Site

City

Pune

ZIP/Postal Code

411001

Country

India

Facility Name

GSK Investigational Site

City

Vellore

ZIP/Postal Code

632004

Country

India

Facility Name

GSK Investigational Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

GSK Investigational Site

City

Galway

Country

Ireland

Facility Name

GSK Investigational Site

City

James Street

ZIP/Postal Code

Country

Ireland

Facility Name

GSK Investigational Site

City

Petach-Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

GSK Investigational Site

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

GSK Investigational Site

City

Aichi

ZIP/Postal Code

466-8650

Country

Japan

Facility Name

GSK Investigational Site

City

Akita

ZIP/Postal Code

010-8543

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

811-1395

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

GSK Investigational Site

City

Hyogo

ZIP/Postal Code

650-0047

Country

Japan

Facility Name

GSK Investigational Site

City

Ibaraki

ZIP/Postal Code

305-8576

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

236-0004

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

259-1143

Country

Japan

Facility Name

GSK Investigational Site

City

Kyoto

ZIP/Postal Code

602-8566

Country

Japan

Facility Name

GSK Investigational Site

City

Miyagi

ZIP/Postal Code

980-8574

Country

Japan

Facility Name

GSK Investigational Site

City

Nagano

ZIP/Postal Code

390-8621

Country

Japan

Facility Name

GSK Investigational Site

City

Nagasaki

ZIP/Postal Code

852-8501

Country

Japan

Facility Name

GSK Investigational Site

City

Okayama

ZIP/Postal Code

700-8558

Country

Japan

Facility Name

GSK Investigational Site

City

Osaka

ZIP/Postal Code

589-8511

Country

Japan

Facility Name

GSK Investigational Site

City

Tochigi

ZIP/Postal Code

329-0498

Country

Japan

Facility Name

GSK Investigational Site

City

Tokushima

ZIP/Postal Code

770-8503

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

113-8655

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

162-8655

Country

Japan

Facility Name

GSK Investigational Site

City

Jellanamdo

ZIP/Postal Code

519-809

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Amersfoort

ZIP/Postal Code

3818 ES

Country

Netherlands

Facility Name

GSK Investigational Site

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

GSK Investigational Site

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

GSK Investigational Site

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Den Haag

ZIP/Postal Code

2545 CH

Country

Netherlands

Facility Name

GSK Investigational Site

City

Enschede

ZIP/Postal Code

7511JX

Country

Netherlands

Facility Name

GSK Investigational Site

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Hoofddorp

ZIP/Postal Code

2134 TM

Country

Netherlands

Facility Name

GSK Investigational Site

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

GSK Investigational Site

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

GSK Investigational Site

City

Nieuwegein

ZIP/Postal Code

3435 CM

Country

Netherlands

Facility Name

GSK Investigational Site

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

GSK Investigational Site

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

GSK Investigational Site

City

Rotterdam

ZIP/Postal Code

3075 EA

Country

Netherlands

Facility Name

GSK Investigational Site

City

Rotterdam

ZIP/Postal Code

3079 DZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Sittard-geleen

ZIP/Postal Code

6162 BG

Country

Netherlands

Facility Name

GSK Investigational Site

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

GSK Investigational Site

City

Zwolle

ZIP/Postal Code

8025 AB

Country

Netherlands

Facility Name

GSK Investigational Site

City

Oslo

ZIP/Postal Code

0310

Country

Norway

Facility Name

GSK Investigational Site

City

Chorzow

ZIP/Postal Code

41-500

Country

Poland

Facility Name

GSK Investigational Site

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

GSK Investigational Site

City

Poznan

ZIP/Postal Code

60-833

Country

Poland

Facility Name

GSK Investigational Site

City

Warszawa

ZIP/Postal Code

02-776

Country

Poland

Facility Name

GSK Investigational Site

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

GSK Investigational Site

City

Wroclaw

ZIP/Postal Code

50-367

Country

Poland

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

125101

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St-Petersburg

ZIP/Postal Code

197110

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28008

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

GSK Investigational Site

City

Majadahonda (Madrid)

ZIP/Postal Code

28222

Country

Spain

Facility Name

GSK Investigational Site

City

Murcia

ZIP/Postal Code

30120

Country

Spain

Facility Name

GSK Investigational Site

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

GSK Investigational Site

City

Pozuelo de Alarcón/Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

GSK Investigational Site

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

GSK Investigational Site

City

Göteborg

Country

Sweden

Facility Name

GSK Investigational Site

City

Lund

ZIP/Postal Code

SE-221 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Stockholm

ZIP/Postal Code

SE-141 86

Country

Sweden

Facility Name

GSK Investigational Site

City

Uppsala

ZIP/Postal Code

SE-751 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

GSK Investigational Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

GSK Investigational Site

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

GSK Investigational Site

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Blackpool

ZIP/Postal Code

FY3 8NR

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Bristol

ZIP/Postal Code

BS2 8ED

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Cambridge

ZIP/Postal Code

CB2 2XY

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Cheltenham

ZIP/Postal Code

GL53 7AN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Glasgow

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Headington, Oxford

ZIP/Postal Code

OX3 7LE

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Liverpool

ZIP/Postal Code

L7 8XP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

NW1 2PG

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

W12 0HS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Newcastle upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Northwood

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Nottingham

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Sheffield

ZIP/Postal Code

S10 2JF

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Whitchurch, Cardiff

ZIP/Postal Code

CF14 2TL

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Wolverhampton

ZIP/Postal Code

WV10 OQP

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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

Lymphoma, Large-Cell, Diffuse

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial