Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia

Summary

This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy 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. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.

Conditions

• Acute Lymphoblastic Leukemia
• B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic hematopoietic SCT

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

BIOLOGICAL

Blinatumomab

Given IV

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT, IV, or SC

DRUG

Daunorubicin

Given IV

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Dexamethasone

Given PO

DRUG

Etoposide

Given IV

DRUG

Leucovorin Calcium

Given IV or PO

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given PO, IT or IV

DRUG

Pegaspargase

Given IM or IV

DRUG

Prednisone

Given PO

BIOLOGICAL

Rituximab

Given IV

DRUG

Vincristine

Given IV

DRUG

Vincristine Sulfate

Given IV

PROCEDURE

X-Ray Imaging

Undergo x-ray imaging

Sponsors & Collaborators

• Canadian Cancer Trials Group

  collaborator NETWORK

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Mark R Litzow · ECOG-ACRIN Cancer Research Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-05-19

Primary Completion

2023-06-23

Completion

2027-02-25

FDA Drug

Yes

Countries

• United States
• Canada
• Israel
• Puerto Rico

Study Locations