Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia

Summary

This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Immunotherapy with blinatumomab may allow the body's immune system to attack and destroy some types of leukemia cells. It is not yet known whether blinatumomab is more effective than standard combination chemotherapy in treating relapsed B-cell acute lymphoblastic leukemia.

Conditions

• Recurrent B Acute Lymphoblastic Leukemia

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic HSCT

DRUG

Asparaginase

Given IM or IV

BIOLOGICAL

Blinatumomab

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT and IV or SC

DRUG

Dexamethasone

Given PO or IV

DRUG

Etoposide

Given IV

DRUG

Leucovorin Calcium

Given IV or PO

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IT, IV, and PO

DRUG

Mitoxantrone

Given IV

DRUG

Mitoxantrone Hydrochloride

Given IV

DRUG

Pegaspargase

Given IV

OTHER

Pharmacological Study

Correlative studies

RADIATION

Radiation Therapy

Undergo cranial radiation therapy

DRUG

Therapeutic Hydrocortisone

Given IT

DRUG

Thioguanine

Given PO

DRUG

Vincristine

Given IV

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Patrick A Brown · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

31 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-17

Primary Completion

2021-06-30

Completion

2026-09-16

Countries

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

Study Locations