MedTrace Logo

Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

NCT00720109 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2020-04-13

Study results available
· View outcomes & findings →

Summary

This phase II/III trial is studying the side effects and how well giving dasatinib together with combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia (ALL). Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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 dasatinib together with combination chemotherapy may kill more cancer cells.

Conditions

  • Acute Lymphoblastic Leukemia
  • Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
  • Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

Interventions

DRUG

Asparaginase

Given IT

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT or IV

DRUG

Dasatinib

Given PO

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Dexamethasone

Given IV or PO

DRUG

Etoposide

Given IV

BIOLOGICAL

Filgrastim

Given IV or SC

DRUG

Hydrocortisone Sodium Succinate

Given IT

DRUG

Ifosfamide

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Leucovorin Calcium

Given IV or PO

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IT, PO, or IV

DRUG

Methylprednisolone

Given IV

DRUG

Pegaspargase

Given IM

DRUG

Prednisone

Given PO or IV

RADIATION

Radiation Therapy

Some patients undergo cranial RT

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • William B Slayton · Children's Oncology Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-14
Primary Completion
2014-12-31
Completion
2020-03-31

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00720109 on ClinicalTrials.gov