Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia

Summary

This phase II trial studies the side effects and how well blinatumomab and combination chemotherapy or dasatinib, prednisone, and blinatumomab work in treating older patients with acute lymphoblastic leukemia. 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. Chemotherapy drugs, such as prednisone, vincristine sulfate, methotrexate, and mercaptopurine, 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. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab with combination chemotherapy or dasatinib and prednisone may kill more cancer cells.

Conditions

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

Interventions

PROCEDURE

Biopsy Procedure

Undergo a biopsy

PROCEDURE

Biospecimen Collection

Undergo a blood sample collection

BIOLOGICAL

Blinatumomab

Given IV

PROCEDURE

Bone Marrow Aspiration and Biopsy

Undergo a bone marrow aspiration and biopsy

PROCEDURE

Computed Tomography

Undergo a CT scan

DRUG

Dasatinib

Given PO

PROCEDURE

Echocardiography Test

Undergo ECHO

PROCEDURE

Lumbar Puncture

Undergo a lumbar puncture

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given PO

DRUG

Methotrexate Sodium

Given PO

DRUG

Prednisone

Given PO

DRUG

Vincristine

Given IV

DRUG

Vincristine Sulfate

Given IV

PROCEDURE

X-Ray Imaging

Undergo an x-ray

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Anjali S Advani · SWOG Cancer Research Network

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2022-06-01

Completion

2027-01-26

Countries

• United States

Study Locations