Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.

Study summary

To evaluate the safety, efficacy and pharmacokinetics of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to \<18 years).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiednilotinib

The study team can explain what participation involves.

Who it may be forPhiladelphia Positive (Ph+) Chronic Myelogenous Leukemia

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 22, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?36 U.S. locations

Locations may change over time.

Who runs it?Novartis Pharmaceuticals

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Novartis Pharmaceuticals
Interventions being studied: Drug: nilotinib

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Key
Newly diagnosed and untreated Ph+ CML CP or Ph+ CML CP or AP resistant or intolerant to either imatinib or dasatinib
Karnofsky ≥ 50% for patients \> 10 years of age and Lansky ≥ 50 for patients ≤ 10 years of age
Adequate renal, hepatic and pancreatic function
Potassium, magnesium, phosphorus and total calcium values ≥ LLN (lower limit of normal)
Written informed consent Key

Reasons someone may not be able to joinExclusion criteria

Treatment with strong CYP3A4 inhibitors or inducers
Use or planned use of any medications that have a known risk or possible risk to prolong the QT interval
Acute or chronic liver, pancreatic or severe renal disease
History of pancreatitis or chronic pancreatitis.
Impaired cardiac function
No evidence of active graft vs host and \<3mo since Stem Cell Transplant
Total body irradiation (TBI) or craniospinal radiation therapy \<6months
Hypersensitivity to the active ingredient or any of the excipients including lactose.
the criteria regarding pregnancy and contraception
Active or systemic bacterial, fungal, or viral infection
known Hepatitis B, Hepatitis C, or HIV infection

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Loma Linda University Cancer CenterLoma Linda, California
Lucile Salter Packard Children's Hospital at StanfordPalo Alto, California
Nemours Childrens HospitalOrlando, Florida
St. Mary's HospitalWest Palm Beach, Florida
Johns Hopkins Oncology Center ORABaltimore, Maryland
UNC Chapel HillChapel Hill, North Carolina
Nationwide Childrens HospitalColumbus, Ohio
University of Texas Southwestern Medical Center OncologyDallas, Texas
Cook Children's Medical Center OncologyFort Worth, Texas
Seattle Childrens HospitalSeattle, Washington
Novartis Investigative SiteBordeaux, Aquitaine
Novartis Investigative SiteLille

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 22, 2021. Always confirm current availability with the study team.

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