RecruitingPhase 1Phase 2NCT01371630

Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia

Phase I/II Study of the Combination of Inotuzumab Ozogamycin (CMC-544) With Low-Intensity Chemotherapy in Patients With Acute Lymphoblastic Leukemia (ALL)


Sponsor

M.D. Anderson Cancer Center

Enrollment

276 participants

Start Date

Aug 26, 2011

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I/II trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating patients with acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers CalichDMH to kill them. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy 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 together with combination chemotherapy may be a better treatment for acute lymphoblastic leukemia.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a new drug called inotuzumab ozogamicin combined with chemotherapy to treat a type of blood cancer called acute lymphoblastic leukemia (ALL) in older or less healthy adults. **You may be eligible if...** - You are 60 years of age or older with a newly diagnosed ALL blood cancer (pre-B type), and have received little or no prior treatment - You are 18–59 years old with the same type of ALL but are considered unfit for standard intensive chemotherapy due to health conditions such as heart problems, lung problems, kidney problems, liver problems, or a general low energy/fitness level (ECOG score of 2 or higher) - You are 60 or older with health conditions that make you unable to tolerate aggressive chemotherapy - You have reasonable liver and kidney function - You are willing and able to give informed consent **You may NOT be eligible if...** - You have active, uncontrolled infection or serious illness not related to the cancer - Your liver or kidney function is severely impaired beyond study limits - You are pregnant or breastfeeding - You have a prior history of certain serious heart conditions (like QT prolongation) - You are unwilling to provide consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALBlinatumomab

Given CIVI

DRUGCyclophosphamide

Given IV

DRUGCytarabine

Given IT and IV

DRUGDexamethasone

Given IV or PO

BIOLOGICALInotuzumab Ozogamicin

Given IV

OTHERLaboratory Biomarker Analysis

Correlative studies

DRUGMercaptopurine

Given PO

DRUGMethotrexate

Given IT, IV, and PO

DRUGPrednisone

Given PO

BIOLOGICALRituximab

Given IV

DRUGVincristine

Given IV


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT01371630


Related Trials