NCT03150693|RecruitingPhase 3DMCFDA Drug

Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia

A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) With Newly Diagnosed Precursor B-Cell ALL

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

A041501NCI-2016-01981U10CA180821

Study Type

interventional

Target

310

Locations

2 countries

Sites

460

Timeline

RegisteredMay 2017

StartedSep 2017

CompletionAug 2027

Brief Summary

This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.

Trial Health

On Track

Trial Health Score

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

Enrollment

310

participants targeted

Target at P50-P75 for phase_3

Timeline

14mo left

Started Sep 2017

Longer than P75 for phase_3

Geographic Reach

2 countries

460 active sites

Status

recruiting

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

9.9 years study duration

Study Progress89%

Sep 2017Aug 2027

First Submitted

Initial submission to the registry

May 9, 2017

Completed

3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed

4 months until next milestone

Study Start

First participant enrolled

September 20, 2017

Completed

9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

June 2, 2026

Status Verified

June 1, 2026

Enrollment Period

9.4 years

First QC Date

May 9, 2017

Last Update Submit

June 1, 2026

Conditions

B Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

EFS
Will be compared using log-rank tests. EFS curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model. The corresponding hazard ratio, 2- and 3-year EFS estimates will be assessed, and EFS medians along with their 95% confidence intervals for the two treatment arms.
Time from induction response to the time of progressive-disease, secondary malignancy, or death, assessed up to 3 years

Secondary Outcomes (7)

DFS
Time from achievement of CR to the time of relapse and/or death, assessed up to 10 years
OS
Time from randomization to the time of death due to any cause, assessed up to 10 years
Proportion of patients who achieve CR or any response to induction therapy
Up to 10 years
Overall induction response rates
Up to 10 years
Incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0
Up to 10 years
+2 more secondary outcomes

Study Arms (2)

Arm I (frontline chemotherapy)

ACTIVE COMPARATOR

See detailed description.

Drug: AllopurinolDrug: CytarabineDrug: Daunorubicin HydrochlorideDrug: Vincristine SulfateDrug: DexamethasoneDrug: Pegylated L-AsparaginaseDrug: MethotrexateProcedure: Bone Marrow Aspiration and BiopsyDrug: CyclophosphamideDrug: MercaptopurineBiological: RituximabDrug: ThioguanineOther: Laboratory Biomarker Analysis

Arm II (frontline chemotherapy, inotuzumab ozogamicin)

EXPERIMENTAL

Patients receive inotuzumab ozogamicin IV on days 1, 8, and 15 and undergo bone marrow aspirate and biopsy on day 28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients also receive remission consolidated chemotherapy, interim maintenance chemotherapy, delayed intensification, and maintenance therapy as in Arm I.