Phase 3
N=447
Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma
Lymphoma, Large-Cell, Diffuse
Bottom Line
View on ClinicalTrials.gov: NCT01014208 ↗Enrolled (actual)
447
Serious AEs
52.4%
Results posted
Oct 2014
Primary outcome: Primary: Progression-free Survival as Assessed by Independent Reviewers — 2.14; 1.81 Months — p=0.333
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OFATUMUMAB + DHAP (Drug); RITUXIMAB + DHAP (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival as Assessed by Independent Reviewers |
2.14; 1.81 | 0.333 |
| SECONDARY Number of Participants With Overall Response (OR) and Complete Response (CR) After Salvage Chemoimmunotherapy |
94; 84; 48; 34 | 0.4053 |
| SECONDARY Number of Participants With Overall Response (OR) and Complete Response (CR) Three Months After Autologous Stem Cell Transplant |
57; 53; 44; 43 | 0.8209 |
| SECONDARY Event-free Survival |
1.84; 1.74 | 0.346 |
| SECONDARY Overall Survival (OS) |
13.17; 13.86 | 0.377 |
| SECONDARY Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram From Peripheral Blood |
121; 120 | 0.1161 |
| SECONDARY Number of Participants Completing Autologous Stem Cell Transplant (ASCT) |
83; 74 | 0.4481 |
| SECONDARY Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) During Treatment |
-2.561; -2.591 | 0.978 |
| SECONDARY Change From Baseline in the Functional Assessment of Cancer Therapy Lymphoma Trial Outcome Index (FACT-Lym TOI) Total Score During Treatment |
-2.028; -3.156 | 0.387 |
| SECONDARY Time to Neutrophil and Platelet Recovery After Each Cycle of Salvage Chemotherapy |
8.0; 11.0; 8.0; 11.0; 10.0; 7.0 | 0.479 |
| SECONDARY Time to Engraftment After High-dose Therapy (HDT)/ASCT |
24.0; NA | 0.035 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01014208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.