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A Study Of Inotuzumab Ozogami...

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

Last Updated: 2019-01-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-02

Study Completion Date

2017-01-04

Brief Summary

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

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Detailed Description

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Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Group Type EXPERIMENTAL

inotuzumab ozogamicin

Intervention Type DRUG

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

Arm B

Group Type ACTIVE_COMPARATOR

FLAG (fludarabine, cytarabine and G-CSF)

Intervention Type 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)

Intervention Type DRUG

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

cytarabine and mitoxantrone

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

HIDAC (high dose cytarabine)

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* CD22 expression
* Adequate liver and renal functions

Exclusion Criteria

* Isolated extramedullary disease
* Active Central Nervous System \[CNS\] disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Investigational Drug Services - UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status

UC San Diego Medical Center - La Jolla

La Jolla, California, United States

Site Status