Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Summary

This phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without lestaurtinib in treating acute lymphoblastic leukemia.

Conditions

• Acute Lymphoblastic Leukemia
• Acute Undifferentiated Leukemia
• Childhood T Acute Lymphoblastic Leukemia

Interventions

DRUG

Asparaginase

Given IV, IM, or PO

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IV or IT

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Dexamethasone

Given IV or PO

PROCEDURE

Echocardiography

Undergo ECHO

DRUG

Etoposide

Given IV

BIOLOGICAL

Filgrastim

Given IV or SC

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Lestaurtinib

Given PO

DRUG

Leucovorin Calcium

Given IV

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IV, IT, or PO

DRUG

Methylprednisolone

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Pegaspargase

Given IM

OTHER

Pharmacological Study

Correlative studies

DRUG

Prednisone

Given PO

DRUG

Therapeutic Hydrocortisone

Given IT

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Joanne M Hilden · Children's Oncology Group

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

1 Year

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-01-15

Primary Completion

2017-09-30

Completion

2024-06-30

Countries

• United States
• Australia
• Canada
• New Zealand

Study Locations