CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib

Novartis Pharmaceuticals128 enrolled

Overview

"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."

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

128

Conditions

Chronic Myelogenous Leukemia in Chronic Phase

Interventions

NilotinibDRUG

Nilotinib was supplied as 150 mg and 200 mg hard gelatin capsules.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (32)

Outcomes

Primary Outcomes

Number of Participants With Confirmed Complete Molecular Response (CMR)

CMR was defined as at least 4.5 log reduction of breakpoint cluster region gene/Abelson proto-oncogene (Bcr-Abl) transcipts from the standardized baseline on the international scale (equivalent to Bcr-Abl \<=0.0032% IS) with a minimum of 25,614 ABL control copies. CMR was to be confirmed by a second polymerase chain reaction (PCR) sample drawn 3 months later where the results should be less than or equal to 0.0032% with a minimum of 25,614 Abelson proto-oncogene (ABL) control copies.

Time frame: 4 years

Secondary Outcomes

Number of Participants With Complete Cytogenetic Response (CCyR) and Major Molecular Response (MMR)

CCyR was defined as 0% Philadelphia chromosome-positive (Ph+) metaphases in the bone marrow. MMR was defined as a 3 log reduction of Bcr-Abl transcripts from the standardized baseline on the international scale (equivalent to Bcr-Abl ≤ 0.1% IS). Bcr-Abl transcripts assessed by peripheral blood quatitative real time polymerase chain reaction (RQ-PCR) were used for the determination of all molecular responses.

Time frame: 4 years

Time to CMR, CCyR and MMR

Time to CMR, CCyR, and MMR was defined as the time from the date of enrollment to the date of first documented CMR, CCyR and MMR, respectively.

Time frame: 4 years

Duration of CMR, CCyR and MMR

Duration of CMR, CCyR and MMR were defined as the time from the first date of achievement of the response to the date of first documented loss of the response.

Time frame: 4 years

Number of Participants With Progression to Accelerated Phase/Blastic Crisis (AP/BC)

Progression to AP/BC is defined as loss of CCyR, MMR, and CMR and was summarized by frequencies and percentages.

Time frame: 4 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Pacific Cancer Medical Center, Inc.

Anaheim, California, United States

Providence St. Joseph Medical Center Roy&Patricia Disney Fam Cancer

Burbank, California, United States

Bay Area Cancer Research Dept.ofBayAreaCancerResearch

Concord, California, United States

St. Jude Heritage Medical Group Virginia Crosson Cancer Center

Yorba Linda, California, United States

Sarah Cannon Research Institute SCRI

Jacksonville, Florida, United States

Advanced Medical Specialties

Miami, Florida, United States

Pasco Hernando Oncology

New Port Richey, Florida, United States

Georgia Regents University MedCollege of GA Cancer Ctr 2

Augusta, Georgia, United States

Stroger Cook County Hospital Division of Hematology & Onc

Chicago, Illinois, United States

Louis A. Weiss Memorial Hospital

Chicago, Illinois, United States

...and 22 more locations

Time to Progression of AP/BC

Time to progression of AP/BC was defined as the time from the date of the first dose of study drug to the date of first documented progression of AP/BC.

Time frame: 4 years

Number of Participants With Loss of CCyR, MMR and CMR

Rate of loss of CMR was defined as an increase in the Bcr-Abl transcripts to greater than 0.0032% IS. Rate of loss of CCyR was defined as an increase in the Ph+ bone marrow cells to greater than 0%. Rate of loss of MMR was defined as an increase in the Bcr-Abl transcripts to greater than 0.1% IS.

Time frame: 4 years

Number of Participants With CMR Who Were Dosed to 400 mg b.i.d.

Time frame: 4 years

Event-free Survival, Progression-free Survival and Overall Survival

Event-free survival was defined as the time from the date of enrollment to the date of first occurrence of any of the following: loss of Complete Hematological Response (CHR), loss of CCyR, loss of Partial Cytogenetic Response (PCyR), progression to the accelerated phase or blast crisis, and death from any cause. Progression-free survival was defined as the time from the date of enrollment to the date of first occurrence of any of the following: progression to the accelerated phase or blast crisis, death, and loss of CMR. Overall survival was defined as the time from the date of enrollment until death due to any cause.

Time frame: 4 years