CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 103 enrolled
Drug / intervention
inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone +1 moredrug
Likely dose
inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone 375 mg/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/NCT01055496
NCT01055496Phase 1Completed
CompareCT.gov

AN OPEN-LABEL, PHASE 1 STUDY OF R-CVP OR R-GDP IN COMBINATION WITH INOTUZUMAB OZOGAMICIN IN SUBJECTS WITH CD22-POSTIVE NON-HODGKIN'S LYMPHOMA

Pfizer·interventional·Posted Jan 25, 2010·Updated Aug 2, 2019

In Brief

A Phase 1 clinical trial evaluating inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone and inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasone for Lymphoma, B-Cell. Completed, enrolled 103 participants across 28 sites in 9 countries.

Detailed Summary

This is a phase 1 trial designed to evaluate safety and tolerability of chemotherapy in combination with inotuzumab ozogamicin, an investigational product, in adults with CD22-positive non-Hodgkin's lymphoma. The trial will involve two arms. In one arm, subjects will receive chemotherapy regimen R-CVP (rituximab, cyclophosphamide, vincristine and prednisone). In the other arm, subjects will receive R-GDP (rituximab, gemcitabine, cisplatinum and dexamethasone). Subjects in both arms will also receive inotuzumab ozogamicin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, B-Cell
CountriesBelgium, Canada, France, Hong Kong, Japan, Singapore, South Korea, United Kingdom, United States
CollaboratorsUCB Pharma

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 25, 2010
Enrollment StartMar 1, 2010
Primary CompletionJul 1, 2013
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.4 years ago

Interventions

inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisonedrug

Day 1: Rituximab at 375 mg/m2 Cyclophosphamide at 375 mg/m2 (cohort 1), 550mg/m2 (cohort 2), 750 mg/m2 (cohort 3, 4) Vincristine at 1.4 mg/m2 (max 2 mg) Day 2 Inotuzumab ozogamicin at 0.8 mg/m2 (cohort 1, 2, 3), 1.3 mg/m2 (cohort 4) Days 1-5: Prednisone at 40 mg/m2 Each cycle is 3 weeks, with a maximum of 6 cycles total.

inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasonedrug

Day 1: Rituximab at 375 mg/m2 Gemcitabine at 500 mg/m2 (cohort 1, 2b, 3b), 1000mg/m2 (cohort 2a, 3a, 4, 5) Cisplatin at 37.5 mg/m2 (cohort 1, 2a), 50mg/m2 (cohort 2b, 3a), 75mg/m2 (cohort 3b, 4, 5) Day 2: Inotuzumab ozogamicin at 0.8 mg/m2 (cohort 1, 2a, 2b, 3a, 3b, 4), 1.3mg/m2 (cohort 5) Days 1-4: Dexamethasone at 40 mg Each cycle is 3 weeks, with a maximum of 6 cycles total.