MedTrace Logo

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia

NCT00866918 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2022-10-25

Study results available
· View outcomes & findings →

Summary

This phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic 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

  • Childhood Acute Promyelocytic Leukemia With PML-RARA
  • Myeloid Neoplasm

Interventions

DRUG

Arsenic Trioxide

Given IV

DRUG

Cytarabine

Given IT or IV

OTHER

Diagnostic Laboratory Biomarker Analysis

Correlative studies

DRUG

Idarubicin

Given IV

DRUG

Mercaptopurine

Given orally

DRUG

Methotrexate

Given orally

DRUG

Mitoxantrone Hydrochloride

Given IV

DRUG

Tretinoin

Given orally

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • John J Gregory · Children's Oncology Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-03-09
Primary Completion
2015-06-30
Completion
2022-09-30

Countries

  • United States
  • Canada
  • Puerto Rico

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 NCT00866918 on ClinicalTrials.gov