A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Summary

This phase II trial studies the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab is an antibody, which is a protein that identifies and targets specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a medicine that may boost a patient's immune system. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer.

Conditions

• Down Syndrome
• Recurrent B Acute Lymphoblastic Leukemia

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo 3D-CRT

PROCEDURE

Biospecimen Collection

Undergo blood, urine and cerebrospinal fluid collection

BIOLOGICAL

Blinatumomab

Given IV

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Calaspargase Pegol

Given IV

DRUG

Cytarabine

Given IT

DRUG

Dexamethasone

Given PO or IV

DRUG

Hydrocortisone Sodium Succinate

Given IT

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IT, PO, and IV

BIOLOGICAL

Nivolumab

Given IV

DRUG

Pegaspargase

Given IM or IV

DRUG

Pegcrisantaspase

Given IM or IV

DRUG

Vincristine Sulfate

Given IV push or via infusion

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Stacy L Cooper · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-17

Primary Completion

2028-06-30

Completion

2028-06-30

FDA Drug

Yes

Countries

• United States
• Australia
• Canada
• Puerto Rico

Study Locations