CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 326 enrolled
Drug / intervention
inotuzumab ozogamicin +3 moredrug
Likely dose
inotuzumab ozogamicin 0.5 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/NCT01564784
NCT01564784Phase 3Completed
CompareCT.gov

AN OPEN-LABEL, RANDOMIZED PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN COMPARED TO A DEFINED INVESTIGATOR'S CHOICE IN ADULT PATIENTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)

Pfizer·interventional·Posted Mar 28, 2012·Updated Jan 9, 2019

In Brief

A Phase 3 clinical trial evaluating inotuzumab ozogamicin, FLAG (fludarabine, cytarabine and G-CSF), and 2 other interventions for Acute Lymphoblastic Leukemia. Completed, enrolled 326 participants across 198 sites in 20 countries.

Detailed Summary

This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia
CountriesArgentina, Australia, Canada, China, Czechia, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Poland, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
CollaboratorsUCB Pharma

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 28, 2012
Enrollment StartAug 2, 2012
Primary CompletionMar 8, 2016
Study CompletionJan 4, 2017
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 14.3 years ago

Interventions

inotuzumab ozogamicindrug

Dose: inotuzumab ozogamicin 0.8-0.5 mg/m\^2 IV, weekly, 3 times per cycle Cycle length: 21-28 days Total number of cycles: 6

FLAG (fludarabine, cytarabine and G-CSF)drug

Dose: cytarabine 2.0 g/m\^2/day IV days 1-6 fludarabine30 mg/m\^2/day IV days 2-6 Cycle length: 28 days Total number of cycles: 4

HIDAC (high dose cytarabine)drug

cytarabine 3 g/m\^2 IV every 12 hours for up to 12 times

cytarabine and mitoxantronedrug

mitoxantrone 12 mg/m\^2 IV days 1-3 cytarabine 200 mg/m\^2/day IV over 7 days cycle length: 15-20 days Total number of cycles: 4