Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations

NCT01131325 | Terminated Phase 4 Results

• 1 other identifier: CAMN107AUS20
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

Brief Summary

This study is to determine the number of European Leukemia Network (ELN)guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations treated with nilotinib.

Conditions

CML; Philadelphia Chromosome Positive (Ph+); Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels

Keywords

Philadelphia chromosome positive; Ph+; chronic myelogenous leukemia chronic phase; CML-CP; low imatinib trough levels

Outcome Measures

Primary Outcomes (1)

• Number of Treatment Failure Events up to 2 Years

  Treatment failure events from time of study entry in Complete molecular response-Chronic phase (CML-CP) participants with low imatinib trough concentrations less than 850 nanogram per milliliter (\<850 ng/mL) treated with nilotinib as defined in European LeukemiaNet (ELN)-guideline.

  up to 2 years

Secondary Outcomes (6)

• European LeukemiaNet (ELN)-Defined Optimal Responses

  up to 2 years

• Loss of Complete Cytogenetic Response (CCyR), Major Molecular Response (MMR) and Complete Molecular Response (CMR) on Nilotinib

  up to 2 years

• Duration of Complete Cytogenetic Response (CCyR), Major Molecular Response (MMR) and Complete Molecular Response (CMR)Achieved on Nilotinib

  up to 2 years

• Event-free Survival (EFS), Progression-free Survival (PFS) and Overall Survival (OS) up to 2 Years

  up to 2 years

• European LeukemiaNet (ELN)-Defined Suboptimal Events

  up to 2 years

Study Arms (1)

Nilotinib

EXPERIMENTAL

Drug: nilotinib

Interventions

nilotinib DRUG

All patients will receive nilotinib 300mg bid po daily. Nilotinib dose is taken every 12 hours

Also known as: AMN107, Tasigna

Nilotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cytogenetically confirmed Ph+ CML-CP Any prior dose of Imatinib
• Imatinib 400 mg daily for ≥7 consecutive days prior to imatinib trough collection
• Imatinib trough plasma concentration \<850 ng/mL

You may not qualify if:

• Prior documented failure events as defined by ELN guidelines:
• Loss of CHR, CCyR, or clonal progression/Ph+
• Less than CHR at 3 months after diagnosis
• No CyR at 6 months after diagnosis
• Less than PCyR at 12 months after diagnosis
• Less than CCyR at 18 months after diagnosis
• Prior accelerated phase or blast phase CML
• Previously documented T315I mutation
• Previous treatment for CML with any other tyrosine kinase inhibitor except for imatinib
• Patients who had any other treatment for CML (transplant) except interferon +/- ara- C, imatinib, hydroxyurea and/or anagrelide
• Impaired cardiac function
• Patients receiving therapy with strong inhibitors of CYP3A4 or medications that prolong the QT interval and cannot be either discontinued or switched to a different medication prior to starting study drug.
• Any other malignancy that is clinically significant or requires active intervention.
• Major surgery within 4 weeks prior to Day 1 of study or who have not recovered from prior surgery
• Treatment with other investigational agents within 30 days of Day 1

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (3)

Comprehensive Cancer Centers of Nevada CCC of Nevada (1)

Las Vegas, Nevada, 89109, United States

Location

Cancer Center of the High Plains

Amarillo, Texas, 79106, United States

Location

Baylor Health Care System/Sammons Cancer Center Dept. of Sammons Cancer (2)

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was terminated early due to slow enrollment.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2010
• First Posted: May 26, 2010
• Study Start: October 21, 2010
• Primary Completion: May 12, 2011
• Study Completion: May 12, 2011
• Last Updated: May 20, 2021
• Results First Posted: May 20, 2021

Record last verified: 2020-10

Locations

US (3)