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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: cytarabine and mitoxantrone; Drug: HIDAC (high dose cytarabine); Drug: FLAG (fludarabine, cytarabine and G-CSF); Drug: inotuzumab ozogamicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01564784

B1931022

2011-005491-41 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 326 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CD22 expression
• Adequate liver and renal functions

Exclusion criteria

• Isolated extramedullary disease
• Active Central Nervous System [CNS] disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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326 participants in 2 patient groups

Arm A

Experimental group

Treatment:

Drug: inotuzumab ozogamicin

Arm B

Active Comparator group

Treatment:

Drug: FLAG (fludarabine, cytarabine and G-CSF)

Drug: cytarabine and mitoxantrone

Drug: HIDAC (high dose cytarabine)