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A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia

NCT01564784 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2019-01-09

Study results available
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Summary

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

Conditions

Interventions

DRUG

inotuzumab ozogamicin

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

DRUG

FLAG (fludarabine, cytarabine and G-CSF)

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

DRUG

HIDAC (high dose cytarabine)

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

DRUG

cytarabine and mitoxantrone

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

Sponsors & Collaborators

  • UCB Pharma

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-02
Primary Completion
2016-03-08
Completion
2017-01-04

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • China
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01564784 on ClinicalTrials.gov