Last updated: 11/03/2018 11:19:37
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Ofatumumab versus Rituximab Salvage Chemoimmunotherapy followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell LymphomaORCHARRD
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: Ofatumumab versus Rituximab Salvage Chemoimmunotherapy followed by Autologous Stem Cell Transplant (ASCT) in Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Progression-free survival as assessed by independent reviewers
Timeframe: 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:
Number of participants with overall response (OR) and complete response (CR) after salvage chemoimmunotherapy
Timeframe: At completion of up to 3 cycles of salvage chemoimmunotherapy (assessed up to 9 weeks)
Number of participants with overall response (OR) and complete response (CR) three months after autologous stem cell transplant
Timeframe: At 3 months after completion of autologous stem cell transplantation (ASCT) (assessed up to 6 months)
Event-free survival
Timeframe: 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)
Overall survival (OS)
Timeframe: From randomization to death due to any cause (assessed for up to 5 years)
Number of participants with the ability to mobilize at least 2 million cluster of differentiation (CD)34+ cells per kilogram from peripheral blood
Timeframe: During Cycles 2 and/or 3 (Weeks 4-9)
Number of participants completing autologous stem cell transplant (ASCT)
Timeframe: Approximately 4 to 6 weeks following Cycle 3 (assessed up to 3 months)
Change from Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) during treatment
Timeframe: Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months])
Change from Baseline in the Functional Assessment of Cancer Therapy Lymphoma Trial Outcome Index (FACT-Lym TOI) total score during treatment
Timeframe: Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months])
Time to neutrophil and platelet recovery after each cycle of salvage chemotherapy
Timeframe: 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)
Time to engraftment after high-dose therapy (HDT)/ASCT
Timeframe: From ASCT up to 42 days post-ASCT (Baseline up to approximately 4.5 months)
Interventions:
Drug: OFATUMUMAB + DHAP
Drug: RITUXIMAB + DHAP
Enrollment:
447
Observational study model:
Not applicable
Primary completion date:
2014-28-02
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Lymphoma, Large-Cell, Diffuse
Product
ofatumumab
Collaborators
Not applicable
Study date(s)
March 2010 to November 2014
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Providence, Rhode Island, United States, 02908
Status
Terminated/Withdrawn
Location
GSK Investigational Site
AMERSFOORT, Netherlands, 3818 ES
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Birmingham, United Kingdom, B15 2TH
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Jackson, Mississippi, United States, 39216-4505
Status
Study Complete
Location
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89081
Status
Study Complete
Location
GSK Investigational Site
Newcastle upon Tyne, United Kingdom, NE7 7DN
Status
Study Complete
Location
GSK Investigational Site
Westwood, Kansas, United States, 66205
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29425
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52074
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Guangzhou, Guangdong, China, 510515
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pozuelo de Alarcón/Madrid, Spain, 28223
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Study Complete
Location
GSK Investigational Site
La Plata, Buenos Aires, Argentina, B1900AXI
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1431FWO
Status
Study Complete
Location
GSK Investigational Site
Guangzhou, Guangdong, China, 510080
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Manchester, United Kingdom, M13 9WL
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48149
Status
Study Complete
Location
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, C1426ANZ
Status
Study Complete
Location
GSK Investigational Site
Headington, Oxford, United Kingdom, OX3 7LE
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98108
Status
Study Complete
Location
GSK Investigational Site
New Haven, Connecticut, United States, 06520
Status
Study Complete
Location
GSK Investigational Site
SITTARD-GELEEN, Netherlands, 6162 BG
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29601
Status
Study Complete
Location
GSK Investigational Site
Wolverhampton, United Kingdom, WV10 OQP
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612-7323
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chaple Hill, North Carolina, United States, 27599-7305
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95816
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Syracuse, New York, United States, 13210
Status
Study Complete
Location
GSK Investigational Site
Whitchurch, Cardiff, United Kingdom, CF14 2TL
Status
Study Complete
Location
GSK Investigational Site
Jellanamdo, South Korea, 519-809
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10065
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
No longer a GSK study
Actual primary completion date
2014-28-02
Actual study completion date
2014-21-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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