Clinical trial NCT01227577: CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib
Official title: A Single-arm, Open-label, Multi-center Study of Complete Molecular Response (CMR) in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Myelogenous Leukemia in Chronic Phase
Keywords: CML
Chronic Myelogenous Leukemia
Leukemia
CML-CP
Nilotinib
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-10-25
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: "This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients."


Eligibility criteria: Inclusion Criteria:

Patients with Ph+ CML-CP within 3 months of diagnosis. Male or female patients' ≥ 18 years of age. Patients must have adequate end organ function.

Exclusion Criteria:

Previously documented T315I mutation. Other CML treatment is an exclusion criteria with the following exception: While awaiting study start, patients may be treated with anagrelide (no treatment duration limit), hydroxyurea (no treatment duration limit), and/or up to a 14 day supply of a tyrosine kinase inhibitor (TKI) approved by the FDA for frontline treatment. Patients taking a TKI prior to study entry must have at least a one day washout from their last dose of medication and have recovered from any side effects of such therapy.

Impaired cardiac function as defined by the protocol. Patients with contraindications to receiving nilotinib, including concomitant medications.

Primary outcomes:
measure: Number of Participants With Confirmed Complete Molecular Response (CMR)
timeFrame: 4 years
Secondary outcomes:
measure: Number of Participants With Complete Cytogenetic Response (CCyR) and Major Molecular Response (MMR)
timeFrame: 4 years
measure: Time to CMR, CCyR and MMR
timeFrame: 4 years
measure: Duration of CMR, CCyR and MMR
timeFrame: 4 years
measure: Number of Participants With Progression to Accelerated Phase/Blastic Crisis (AP/BC)
timeFrame: 4 years
measure: Time to Progression of AP/BC
timeFrame: 4 years
measure: Number of Participants With Loss of CCyR, MMR and CMR
timeFrame: 4 years
measure: Number of Participants With CMR Who Were Dosed to 400 mg b.i.d.
timeFrame: 4 years
measure: Event-free Survival, Progression-free Survival and Overall Survival
timeFrame: 4 years
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center, Inc.
state: California
city: Burbank
country: United States
facility: Providence St. Joseph Medical Center Roy&Patricia Disney Fam Cancer
state: California
city: Concord
country: United States
facility: Bay Area Cancer Research Dept.ofBayAreaCancerResearch
state: California
city: Yorba Linda
country: United States
facility: St. Jude Heritage Medical Group Virginia Crosson Cancer Center
state: California
city: Jacksonville
country: United States
facility: Sarah Cannon Research Institute SCRI
state: Florida
city: Miami
country: United States
facility: Advanced Medical Specialties
state: Florida
city: New Port Richey
country: United States
facility: Pasco Hernando Oncology
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University MedCollege of GA Cancer Ctr 2
state: Georgia
city: Chicago
country: United States
facility: Stroger Cook County Hospital Division of Hematology & Onc
state: Illinois
city: Chicago
country: United States
facility: Louis A. Weiss Memorial Hospital
state: Illinois
city: Beach Grove
country: United States
facility: Indiana Blood and Marrow Institute
state: Indiana
city: Witchita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: New Orleans
country: United States
facility: LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center(3)
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: St. Louis
country: United States
facility: St. Louis University Cancer Center
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center University of Nebraska Med Ctr
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center Dept.of HackensackUniv.MedCtr.
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Ct James P Wilmot Cancer Ctr
state: New York
city: Durham
country: United States
facility: Duke University Medical Center Duke University Med Ctr
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas Cancer Center
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology
state: Tennessee
city: Germantown
country: United States
facility: The Jones Clinic
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology Sarah Cannon Research Inst.
state: Tennessee
city: Dallas
country: United States
facility: Baylor Research Institute Baylor Research Institute (17)
state: Texas
city: Houston
country: United States
facility: Oncology Consultants Oncology Consultants, P.A.
state: Texas
city: Houston
country: United States
facility: Millennium Oncology
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Berdeja JG, Heinrich MC, Dakhil SR, Goldberg SL, Wadleigh M, Kuriakose P, Cortes J, Radich J, Helton B, Rizzieri D, Paley C, Dautaj I, Mauro MJ. Rates of deep molecular response by digital and conventional PCR with frontline nilotinib in newly diagnosed chronic myeloid leukemia: a landmark analysis. Leuk Lymphoma. 2019 Oct;60(10):2384-2393. doi: 10.1080/10428194.2019.1590569. Epub 2019 Mar 26.