Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia

Summary

This randomized clinical trial is studying giving calaspargase pegol together with combination chemotherapy to see how well it works compared with giving pegaspargase together with combination chemotherapy in treating younger patients with newly diagnosed high-risk acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

Conditions

• Acute Lymphoblastic Leukemia
• Adult B Acute Lymphoblastic Leukemia
• Childhood B Acute Lymphoblastic Leukemia

Interventions

DRUG

Calaspargase Pegol-mknl

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IV, IT, PO, or SC

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Dexamethasone

Given PO or IV

DRUG

Doxorubicin Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IV, IT, or PO

DRUG

Pegaspargase

Given IV

OTHER

Pharmacological Study

Correlative studies

DRUG

Prednisone

Given IV or PO

RADIATION

Radiation Therapy

Some patients undergo RT

DRUG

Thioguanine

Given PO

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Anne L Angiolillo · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-07-21

Primary Completion

2011-02-01

Completion

2021-03-31

Countries

• United States

Study Locations