Phase 2 trial compares Inotuzumab Ozogamicin plus R-CVP for DLBCL patients unfit for anthracycline
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Key Takeaway
Note: Phase 2 trial results for Inotuzumab Ozogamicin in DLBCL are pending; no efficacy or safety data are reported.
This was a Phase 2 interventional clinical trial involving 129 patients with diffuse large B-cell lymphoma (DLBCL) who were not suitable for anthracycline-containing chemotherapy. The study compared the efficacy and safety of Inotuzumab Ozogamicin in combination with R-CVP (cyclophosphamide, vincristine, prednisolone, rituximab) against a comparator regimen described as R-G-CVP, which was not fully defined in the source material. The primary outcome was progression-free survival, with a median follow-up of 64.9 months.
No efficacy or safety results are reported in the provided source. The main results, including the outcome, effect size, absolute numbers, and statistical significance for progression-free survival, are all listed as 'not reported.' Similarly, no data on adverse events, serious adverse events, discontinuations, or tolerability are available from this source.
The trial's lead sponsor was University College, London. According to the source, if the regimen is demonstrated to be efficacious and safe, it will be further tested in a Phase 3 trial to determine its potential as a standard of care for this patient population. A key limitation is the absence of reported results, which precludes any clinical assessment. The comparator regimen (R-G-CVP) is also not fully defined, adding to the uncertainty. This report serves only to note the trial's design and pending status; no conclusions regarding clinical practice can be drawn.
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View Original Abstract ↓
Status: COMPLETED | Phase: PHASE2
Condition(s): Diffuse Large B Cell Lymphoma
Intervention(s): Cyclophosphamide (DRUG), Vincristine (DRUG), Prednisolone (DRUG), Rituximab (DRUG), Inotuzumab Ozogamicin (DRUG)
The purpose of this trial is to compare the efficacy and safety of Inotuzumab Ozogamicin in combination with R-CVP with that of R-G-CVP for the treatment of Diffuse Large B Cell Lymphoma (DLBCL) in a population of patients not suitable for anthracycline based chemotherapy.
There is no standard of care for the treatment of this group of patients. If demonstrated to be efficacious and safe to deliver this regimen will be further tested in a phase III trial to determine whether this should become the standard of care amongst patients with DLBCL not fit for anthracycline (R-CHOP).
Detailed: The incidence of DLBCL is increasing and with an expanding elderly population, the incidence will continue to rise. Given that about 40% of cases of DLBCL occur in patients aged over 70 and the number of co-mobilities increases with age, research to investigate the optimal treatment of DLBCL in this group of patients is needed. R-CHOP remains the standard of care for the majority of patients with DLBCL, anthracycline use is precluded in a proportion of these patients by a high risk of developing cardiotoxicity, especially congestive cardiac failure. Currently there is no standard of care for patients who are unfit for anthracycline treatment. It has been routine to omit the doxorubicin from R-CHOP, giving R-CVP instead. However the outcome for patients treated with R-CVP is poor and attemp
Primary Outcome(s): Progression Free Survival
Enrollment: 129 (ACTUAL)
Lead Sponsor: University College, London
Start: 2013-10 | Primary Completion: 2019-03
Results posted: 2026-03-17
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