Nilotinib in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

Phase 2

Completed

• Conditions: Leukemia
• Interventions: Drug: nilotinib; Genetic: cytogenetic analysis; Genetic: mutation analysis; Genetic: polymerase chain reaction; Other: pharmacological study

• Registration Number: NCT00809211
• Lead Sponsor: Cancer Trials Ireland

Brief Summary

RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well nilotinib works in treating patients with newly diagnosed chronic phase chronic myelogenous leukemia.

Detailed Description

OBJECTIVES:

Primary

* To establish the complete cytogenetic response rate at 6 months in patients with newly diagnosed Philadelphia chromosome-positive chronic phase chronic myelogenous leukemia treated with nilotinib.

Secondary

* To establish the complete cytogenetic response rate at 3, 9, 12, 18, and 24 months in these patients.

* To establish the molecular response rate at 3, 6, 9, 12, 18, and 24 months in these patients.

* To establish the safety of this drug in these patients.

* To correlate pharmacokinetic data with response rate and toxicity.

* To correlate Bcr-Abl results using GeneXpert with Bcr-Abl results using international standardized quantitative PCR.

* To estimate the prevalence of Bcr-Abl mutations prior to and during treatment.

OUTLINE: This is a multicenter study.

Patients receive oral nilotinib twice daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Peripheral blood and bone marrow samples are collected periodically for mutation analysis, Bcr-Abl analysis by quantitative PCR, metaphase cytogenetics, and pharmacokinetic analysis.

After completion of study therapy, patients are followed every 3 months for 2 years.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-12-16
• Study First Submitted QC: 2008-12-16
• Study First Posted: 2008-12-17
• Primary Completion: 2011-05
• Study Completion: 2016-02
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-23
• Last Update Posted: 2018-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nilotinib	nilotinib	-
Nilotinib	cytogenetic analysis	-
Nilotinib	mutation analysis	-
Nilotinib	polymerase chain reaction	-
Nilotinib	pharmacological study	-

Primary Outcome Measures

Name	Time	Method
Complete cytogenetic response rate at 6 months as assessed by metaphase analysis	6 months

Secondary Outcome Measures

Name	Time	Method
Overall toxicity rate	6 months
Molecular response rate at 3, 6, 9, 12, 18, and 24 months as assessed by quantitative PCR	6 months
Time to disease progression	6 months
Correlation of pharmacokinetic data with response rate and toxicity	6 months
Correlation of Bcr-Abl results using GeneXpert with Bcr-Abl results using international standardized quantitative PCR	6 months
Duration of event-free survival	6 months
Prevalence of Bcr-Abl mutations prior to and during treatment	6 months

Trial Locations

Locations (6)

Universitätsklinikum Charité Berlin; 🇩🇪 Berlin, Germany

St. James's Hospital; 🇮🇪 Dublin, Ireland

University College Hospital; 🇮🇪 Galway, Ireland

Chaim Sheba Medical Centre; 🇮🇱 Tel Hashomer, Israel

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States

Belfast City Hospital; 🇮🇪 Belfast, Ireland