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Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia

NCT00137111 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2020-09-11

Study results available
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Summary

The primary objective is to estimate the overall event-free survival of children at least one year of age at diagnosis who are treated with risk-directed therapy and to monitor the molecular remission induction rate.

Conditions

  • Lymphoblastic Leukemia, Acute

Interventions

DRUG

Prednisone, Dexamethasone, Vincristine, Daunorubicin

See Detailed Description sections for details on treatment interventions.

DRUG

Doxorubicin, L-asparaginase, PEG-L-asparaginase, Erwinia asparaginase

See Detailed Description sections for details on treatment interventions.

DRUG

Methotrexate, Cyclophosphamide, Cytarabine, Etoposide

See Detailed Description sections for details on treatment interventions.

DRUG

Mercaptopurine, Imatinib

See Detailed Description sections for details on treatment interventions.

PROCEDURE

chemotherapy, intrathecal chemotherapy

See Detailed Description sections for details on treatment interventions.

PROCEDURE

steroid therapy, hematopoietic stem cell transplantation

See Detailed Description sections for details on treatment interventions.

Sponsors & Collaborators

Principal Investigators

  • Ching-Hon Pui, M.D. · St. Jude Children's Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-07-08
Primary Completion
2010-11-30
Completion
2014-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00137111 on ClinicalTrials.gov