Ofatumumab versus Rituximab Salvage Chemoimmunotherapy followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell LymphomaORCHARRD
Trial overview
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)
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)
Participation 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.
- 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.
- 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.
- 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)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
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.