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TERMINATED
NCT03488225
PHASE2

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

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

This phase II trial studies how well combination chemotherapy and inotuzumab ozogamicin work in treating patients with B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, methotrexate and cytarabine, 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. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy and inotuzumab ozogamicin may work better at treating B acute lymphoblastic leukemia.

Official title: Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4

Start Date

2018-03-28

Completion Date

2020-04-02

Last Updated

2026-07-30

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT or IV

DRUG

Dexamethasone

Given IV or PO

DRUG

Doxorubicin Hydrochloride

Given IV

BIOLOGICAL

Inotuzumab Ozogamicin

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Leucovorin Calcium

Given IV

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IT, IV or PO

BIOLOGICAL

Ofatumumab

Given IV

DRUG

Prednisone

Given PO

BIOLOGICAL

Rituximab

Given IV

DRUG

Vincristine Sulfate

Given IV

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States