Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults

Summary

This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.

Conditions

• B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

Interventions

DRUG

Mesna

Given IV

DRUG

Methotrexate

Given IV or IT

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Ponatinib Hydrochloride

Given PO

DRUG

Prednisone

Given PO

DRUG

Vincristine Sulfate

Given IV

DRUG

Dasatinib

Given PO

DRUG

Dexamethasone

Given PO or IV

DRUG

Doxorubicin Hydrochloride

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

PROCEDURE

Electrocardiography

Undergo ECG

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

PROCEDURE

Biospecimen Collection

Correlative studies

BIOLOGICAL

Blinatumomab

Given IV

PROCEDURE

Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IV or IT

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Yishai Ofran · ECOG-ACRIN Cancer Research Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-25

Primary Completion

2028-07-01

Completion

2028-07-01

FDA Drug

Yes

Countries

• United States
• Israel
• Puerto Rico

Study Locations