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Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)

NCT01221376 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-03-26

No results posted yet for this study

Summary

The purpose of this study is to evaluate the hematological, cytogenetic and molecular response to continuous-use of Imatinib in children with CML Ph+.

Conditions

  • Chronic Myeloid Leukemia (CML) With Philadelphia Chromosome-positive (Ph+)

Interventions

DRUG

Imatinib Mesylate

Patient will receive Imatinib Mesylate, continuous-use, 260 mg/m2/day dose, maximum allowed 400 mg, for 24 months.

Sponsors & Collaborators

  • Renato Melaragno

    lead OTHER

Principal Investigators

  • Alejandro M Arancibia, MD · Casa de Saúde santa Marcelina

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-06-30
Completion
2013-12-31

Countries

  • Brazil

Study Locations

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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 NCT01221376 on ClinicalTrials.gov