A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia

Summary

This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs, such as vincristine, dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine, mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, 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. Leucovorin decreases the toxic effects of methotrexate. Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving blinatumomab and combination chemotherapy may work better than combination chemotherapy alone in treating patients with B-ALL. This trial also assigns patients into different chemotherapy treatment regimens based on risk (the chance of cancer returning after treatment). Treating patients with chemotherapy based on risk may help doctors decide which patients can best benefit from which chemotherapy treatment regimens.

Conditions

• B Acute Lymphoblastic Leukemia
• B Lymphoblastic Lymphoma
• Down Syndrome

Interventions

DRUG

Asparaginase Erwinia chrysanthemi

Given IV or IM

BIOLOGICAL

Blinatumomab

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT or IV

DRUG

Dexamethasone

Given PO or IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Leucovorin Calcium

Given PO or IV

DRUG

Mercaptopurine

Given PO

DRUG

Mercaptopurine Oral Suspension

Given PO

DRUG

Methotrexate

Given IT or IV

DRUG

Pegaspargase

Given IV or IM

DRUG

Prednisolone

Given PO or IV

DRUG

Prednisone

Given PO or IV

RADIATION

Radiation Therapy

Undergo cranial radiation therapy

RADIATION

Radiation Therapy

Undergo testicular radiation therapy

DRUG

Thioguanine

Given PO

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Sumit Gupta · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

365 Days

Max Age

31 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-03

Primary Completion

2027-09-30

Completion

2027-09-30

FDA Drug

Yes

Countries

• United States
• Australia
• Canada
• New Zealand
• Puerto Rico

Study Locations