NCT01564784|CompletedPhase 3ResultsDMC

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

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 ClinicalTrials.gov

Compare

2 other identifiers

B19310222011-005491-41

Study Type

interventional

Target

326

Locations

20 countries

Sites

198

Timeline

RegisteredMar 2012

StartedAug 2012

CompletionJan 2017

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

326

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Aug 2012

Typical duration for phase_3

Geographic Reach

20 countries

198 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.4 years study duration

First Submitted

Initial submission to the registry

March 26, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed

4 months until next milestone

Study Start

First participant enrolled

August 2, 2012

Completed

3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2016

Completed

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2017

Completed

1 year until next milestone

Results Posted

Study results publicly available

January 17, 2018

Completed

Last Updated

January 9, 2019

Status Verified

December 1, 2018

Enrollment Period

3.6 years

First QC Date

March 26, 2012

Results QC Date

March 2, 2017

Last Update Submit

December 20, 2018

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC)
CR was the disappearance of leukemia indicated by less than (\<) 5 percent (%) marrow blasts \& absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) greater than or equal to (≥)1000 per microliter (/μL) \& platelets ≥100,000/μL. C1 extramedullary disease status (i.e. complete disappearance of measurable \& non-measurable extramedullary disease with the following exceptions: for participants with at least 1 measurable lesion, all nodal masses greater than (\>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) at baseline must have regressed to less than or equal to (≤) 1.5 cm in GTD; all nodal masses ≥1 cm \& ≤1.5 cm in GTD at baseline must have regressed to \<1 cm GTD or reduced by 75% in sum of products of greatest diameters, no new lesions, spleen \& other previously enlarged organs must have regressed in size \& must not be palpable) was required. CRi was defined as CR except ANC \<1000/μL \&/or platelets \<100,000/μL.
Screening, Day 16 to 28 of Cycles 1, 2 and 3, then every 1 to 2 cycles (or as clinically indicated) up to approximately 4 weeks (end of treatment [EoT]) from the last dose
Overall Survival (OS)
OS was defined as the time from randomization to date of death due to any cause. Participants last known to be alive were censored at date of last contact.
Up to 5 years after randomization or 2 years from randomization of the last participant, whichever occurs first.

Secondary Outcomes (10)

Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment)
Up to 2 years from randomization
Progression-Free Survival (PFS)
Up to 2 years from randomization
Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT)
Up to 19 weeks from last dose
Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment)
Up to approximately 4 weeks (EoT) from last dose of study drug
Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment)
Up to approximately 4 weeks (EoT) from last dose of study drug
+5 more secondary outcomes

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: inotuzumab ozogamicin

Arm B

ACTIVE COMPARATOR

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

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

Arm A

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

Arm B

HIDAC (high dose cytarabine)DRUG

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

Arm B

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

Arm B

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

CD22 expression
Adequate liver and renal functions

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead
UCB Pharmacollaborator

Study Sites (198)

Investigational Drug Services - UC San Diego Moores Cancer Center

La Jolla, California, 92037-0845, United States

Location

UC San Diego Medical Center - La Jolla

La Jolla, California, 92037, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093-0698, United States

Location

Children's Center for Cancer and Blood Diseases, Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Keck Hospital of USC