CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 129 enrolled
Drug / intervention
Cyclophosphamide +5 moredrug
Likely dose
Cyclophosphamide 750mg/m2from 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/NCT01679119
NCT01679119Phase 2Completed
CompareCT.gov

A Randomised Phase II Trial of Inotuzumab Ozogamicin Plus Rituximab & CVP (IO-R-CVP) vs Gemcitabine Plus Rituximab & CVP (Gem-R-CVP) for the First Line Treatment of Patients With DLBCL Who Are Not Suitable for Anthracycline Containing Chemotherapy

University College, London·interventional·Posted Sep 5, 2012·Updated Apr 7, 2026

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide, Vincristine, and 4 other interventions for Diffuse Large B Cell Lymphoma. Completed, enrolled 129 participants across 40 sites.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse Large B Cell Lymphoma
CountriesUnited Kingdom
CollaboratorsPfizer, Cancer Research UK

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 5, 2012
Enrollment StartOct 1, 2013
Primary CompletionMar 1, 2019
Study CompletionMar 1, 2022
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 13.8 years ago

Interventions

Cyclophosphamidedrug

Cyclophosphamide 750mg/m2 IV, given day 1

Vincristinedrug

Vincristine 1.4mg/m2(max 2mg)IV given day 1

Prednisolonedrug

Prednisolone 100mg OD Oral given days 1-5

Rituximabdrug

Rituximab 375mg/m2 IV given day 1

Inotuzumab Ozogamicindrug

Inotuzumab Ozogamicin 0.8mg/m2 IV given on day 2

Gemcitabinedrug

Gemcitabine up to 1g/m2 IV given day 1 and day 8 (Patients with ECOG PS 0-1: starting dose: 875mg/m2 (1st cycle). If tolerated can be escalated to 1g/m2 in cycle 2 and subsequent cycles. Patients with ECOG PS 2: starting dose 750mg/m2 (1st cycle). If tolerated can be escalated to 875mg/m2 in cycle 2 and then escalated to 1g/m2 in cycle 3 and subsequent cycles.)