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

NCT02877303 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

  • B Acute Lymphoblastic Leukemia
  • B Lymphoblastic Lymphoma

Interventions

BIOLOGICAL

Blinatumomab

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT and IV

DRUG

Dexamethasone

Given PO

DRUG

Doxorubicin Hydrochloride

Given IV

BIOLOGICAL

Inotuzumab Ozogamicin

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IT, IV, and PO

BIOLOGICAL

Ofatumumab

Given IV

DRUG

Prednisone

Given PO

BIOLOGICAL

Rituximab

Given IV

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Elias Jabbour · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-01
Primary Completion
2026-11-01
Completion
2026-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02877303 on ClinicalTrials.gov