CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
Inotuzumab Ozogamicindrug
Likely dose
Inotuzumab Ozogamicin 0.8 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/NCT01363297
NCT01363297Phase 2Completed
CompareCT.gov

An Open-label, Phase 1/2 Study Of Inotuzumab Ozogamicin In Subjects With Relapsed Or Refractory Cd22-positive Acute Lymphocytic Leukemia

Pfizer·interventional·Posted Jun 1, 2011·Updated Apr 13, 2017

In Brief

A Phase 2 clinical trial evaluating Inotuzumab Ozogamicin for Acute Lymphocytic Leukemia. Completed, enrolled 72 participants across 15 sites.

Detailed Summary

The Phase 1 portion of this study will assess the safety, tolerability and efficacy at increasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed or refractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2 dose (RP2D) and schedule. The Phase 2 portion of the study will evaluate the efficacy of inotuzumab ozogamicin as measured by hematologic remission rate (CR + CRi) in patients in second or later salvage status.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphocytic Leukemia
CountriesUnited States
CollaboratorsUCB Pharma

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 1, 2011
Enrollment StartAug 1, 2011
Primary CompletionAug 1, 2014
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 15.1 years ago

Interventions

Inotuzumab Ozogamicindrug

Part 1: Administered intravenously as 2 - 3 weekly doses over a 28-day cycle for a maximum of 6 cycles. Total dose per cycle 0.8 mg/m\^2 to 2.0 mg/m\^2. Part 2 Expansion and Part 3 Phase 2: Administered intravenously as 3 weekly doses over a 28-day cycle for a maximum of 6 cycles. Total initial dose per cycle 1.8 mg/m\^2.