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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations

NCT02883049 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5949

Last updated 2026-05-04

Study results available
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Summary

This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Chemotherapy drugs, 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) and giving the drugs in different doses and in different combinations may kill more cancer cells.

Conditions

  • B Acute Lymphoblastic Leukemia
  • B Acute Lymphoblastic Leukemia, BCR-ABL1-Like
  • Central Nervous System Leukemia
  • Testicular Leukemia

Interventions

DRUG

Clofarabine

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT, IV, or SC

DRUG

Dasatinib

Given PO

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Dexamethasone

PO or IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide

Given IV

DRUG

Hydrocortisone Sodium Succinate

Given IT

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Leucovorin Calcium

Given PO or IV

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IT and IV

DRUG

Pegaspargase

Given IV

DRUG

Prednisone

Given PO or IV

RADIATION

Radiation Therapy

Undergo radiation therapy

DRUG

Thioguanine

Given PO

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Michael J Burke · Children's Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
31 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2022-12-31
Completion
2026-10-03

Countries

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

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02883049 on ClinicalTrials.gov