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

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.

Conditions

• B Acute Lymphoblastic Leukemia

Interventions

DRUG

Allopurinol

Given PO

DRUG

Cytarabine

Given IT, IV, SC

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Vincristine Sulfate

Given IV

DRUG

Dexamethasone

Given PO or IV

DRUG

Pegylated L-Asparaginase

Given IV

DRUG

Methotrexate

Given IT, IV, PO

PROCEDURE

Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

DRUG

Cyclophosphamide

Given IV

DRUG

Mercaptopurine

Given PO

BIOLOGICAL

Rituximab

Given IV

DRUG

Doxorubicin

Given IV

DRUG

Thioguanine

Given PO

BIOLOGICAL

Inotuzumab Ozogamicin

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Alliance for Clinical Trials in Oncology

  lead OTHER

Principal Investigators

• [email protected] J. DeAngelo, MD, PhD · Dana-Farber Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

39 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-20

Primary Completion

2027-03-01

Completion

2027-08-31

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations