Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma

Summary

This partially randomized phase III trial studies the side effects of different combinations of risk-adapted chemotherapy regimens and how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized). Drugs used in chemotherapy 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. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.

Conditions

• Acute Lymphoblastic Leukemia
• Adult B Lymphoblastic Lymphoma
• Ann Arbor Stage I B Lymphoblastic Lymphoma
• Ann Arbor Stage II B Lymphoblastic Lymphoma
• Childhood B Acute Lymphoblastic Leukemia
• Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
• Childhood B Lymphoblastic Lymphoma
• Down Syndrome
• Hypodiploid B Acute Lymphoblastic Leukemia
• Philadelphia Chromosome Positive

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT, IV, or SC

DRUG

Dexamethasone

Given orally (PO) or IV

DRUG

Doxorubicin Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Leucovorin Calcium

Given PO

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IT, PO, or IV

DRUG

Pegaspargase

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

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

1 Year

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-08-11

Primary Completion

2019-03-31

Completion

2026-03-31

Countries

• United States
• Australia
• Canada
• Ireland
• New Zealand
• Puerto Rico
• Switzerland

Study Locations