Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy for Adults With B-Cell Acute Lymphoblastic Leukemia or B-Cell Lymphoblastic Lymphoma

Summary

This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy to the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a drug, called CalichDMH. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers CalichDMH to kill them. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may help shrink the cancer and stop it from returning.

Conditions

• B Acute Lymphoblastic Leukemia
• B Lymphoblastic Lymphoma

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Vincristine

Given IV

DRUG

Dexamethasone

Given IV or PO

BIOLOGICAL

Inotuzumab Ozogamicin

Given IV

DRUG

Methotrexate

Given IV or PO

DRUG

Cytarabine

Given IV

DRUG

Methylprednisolone

Given IV

BIOLOGICAL

Rituximab

Given IV

DRUG

Prednisone

Given PO

DRUG

Mercaptopurine

Given PO

DRUG

Doxorubicin

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Alliance for Clinical Trials in Oncology

  lead OTHER

Principal Investigators

• Marlise R. Luskin, MD, MSCE · Dana-Farber Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-09

Primary Completion

2027-04-01

Completion

2029-05-31

FDA Drug

Yes

Countries

• United States
• Puerto Rico

Study Locations