RecruitingPhase 2NCT02877303

Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia

Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Blinatumomab With or Without Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia


Sponsor

M.D. Anderson Cancer Center

Enrollment

80 participants

Start Date

Nov 1, 2016

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies how well blinatumomab, inotuzumab ozogamicin, and combination chemotherapy work as frontline therapy in treating patients with B acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, cytarabine, mercaptopurine, methotrexate, and prednisone 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 blinatumomab, inotuzumab ozogamicin, and combination chemotherapy may work better in treating patients with B acute lymphoblastic leukemia than chemotherapy alone.


Eligibility

Min Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two newer targeted drugs — blinatumomab and inotuzumab ozogamicin — together with standard chemotherapy as a first-line treatment for adults newly diagnosed with B-cell acute lymphoblastic leukemia (a fast-growing blood cancer). **You may be eligible if...** - You have been newly diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) or a related blood cancer called lymphoblastic lymphoma - You have had no more than one prior round of chemotherapy (or none at all) - You are physically well enough to tolerate intensive treatment **You may NOT be eligible if...** - You have already received multiple rounds of chemotherapy for this cancer - You have certain infections (like active hepatitis or HIV) or serious organ problems - You have active or uncontrolled infection Combining these newer drugs with chemotherapy may lead to better outcomes than chemotherapy alone. 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.

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Interventions

BIOLOGICALBlinatumomab

Given IV

DRUGCyclophosphamide

Given IV

DRUGCytarabine

Given IT and IV

DRUGDexamethasone

Given PO

DRUGDoxorubicin Hydrochloride

Given IV

BIOLOGICALInotuzumab Ozogamicin

Given IV

OTHERLaboratory Biomarker Analysis

Correlative studies

DRUGMercaptopurine

Given PO

DRUGMethotrexate

Given IT, IV, and PO

BIOLOGICALOfatumumab

Given IV

DRUGPrednisone

Given PO

BIOLOGICALRituximab

Given IV

DRUGVincristine Sulfate

Given IV


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT02877303


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