CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 447 enrolled
Drug / intervention
OFATUMUMAB + DHAP +1 moredrug
Likely dose
OFATUMUMAB + DHAP 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01014208
NCT01014208Phase 3Completed
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Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant (ASCT) in Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

GlaxoSmithKline·interventional·Posted Nov 16, 2009·Updated Aug 7, 2015

In Brief

A Phase 3 clinical trial evaluating OFATUMUMAB + DHAP and RITUXIMAB + DHAP for Lymphoma, Large-Cell, Diffuse. Completed, enrolled 447 participants across 173 sites in 26 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Large-Cell, Diffuse
CountriesArgentina, Austria, Belgium, China, Czechia, Denmark, Estonia, Finland, Germany, Greece, Hungary, India, Ireland, Israel, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Korea, Spain, Sweden, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 16, 2009
Enrollment StartMar 1, 2010
Primary CompletionFeb 1, 2014
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 16.6 years ago

Interventions

OFATUMUMAB + DHAPdrug

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.

RITUXIMAB + DHAPdrug

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.