Efficacy and Safety of Nilotinib Patients With Newly Diagnosed CML - CP (Chronic Myelogenous Leukemia - Chronic Phase)

Myelogenous Leukemia, Chronic Clinical Trial

— PHCHBS-WD4070  

Official title:

Extension Study to a Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00718263
• Other study ID #: CAMN107A2303E1
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 2008
• Est. completion date: October 2018

Study information

• Verified date: October 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and tolerability of nilotinib after failure of imatinib therapy or imatinib therapy after nilotinib failure.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Male or female patients = 18 years of age.

2. ECOG 0, 1, or 2.

3. Patients with Ph+ CML who have failed treatment in the core protocol.

4. Diagnosis of chronic myelogenous leukemia with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations (presence of BCR-ABL a review of a minimum 20 metaphases is required).

5. Adequate end organ function as defined by:

• Total bilirubin < 1.5 x ULN,

• SGOT and SGPT < 2.5 x ULN,

• Creatinine < 1.5 x ULN,

• Serum amylase and lipase = 1.5 x ULN,

• Alkaline phosphatase = 2.5 x ULN unless considered tumor related.

6. Patients must have the following laboratory values (= LLN (lower limit of normal) or corrected to within normal limits with supplements prior to the first dose of study medication.):

• Potassium = LLN,

• Magnesium = LLN,

• Phosphorus = LLN,

• Total calcium (corrected for serum albumin) = LLN.

Exclusion criteria:

1. Previously documented T315I mutations.

2. Impaired cardiac function including any one of the following:

• LVEF < 45% or below the institutional lower limit of the normal range (whichever is higher) as determined by locally read echocardiogram.

• Inability to determine the QT interval on ECG.

• Complete left bundle branch block.

• Use of a ventricular-paced pacemaker.

• Congenital long QT syndrome or a known family history of long QT syndrome.

• History of or presence of clinically significant ventricular or atrial tachyarrhythmias.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase
• Myelogenous Leukemia, Chronic

Intervention

Drug:
• Nilotinib

• Imatinib

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Yvoir
Brazil	Novartis Investigative Site	Curitiba	PR
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	São Paulo	SP
Colombia	Novartis Investigative Site	Bogotá	Cundinamarca
Czechia	Novartis Investigative Site	Praha 2	Czech Republic
Denmark	Novartis Investigative Site	Copenhagen
Egypt	Novartis Investigative Site	Cairo
Finland	Novartis Investigative Site	HUS
France	Novartis Investigative Site	Angers Cedex 1
France	Novartis Investigative Site	Bordeaux
France	Novartis Investigative Site	Saint Priest en Jarez Cedex
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Koeln
Italy	Novartis Investigative Site	Bologna	BO
Italy	Novartis Investigative Site	Roma	RM
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Hamamatsu-city	Shizuoka
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Japan	Novartis Investigative Site	Tsu-city	Mie
Poland	Novartis Investigative Site	Katowice
Poland	Novartis Investigative Site	Lublin
Poland	Novartis Investigative Site	Rzeszow
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Wroclaw
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Novosibirsk
Russian Federation	Novartis Investigative Site	Saint Petersburg
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Bilbao	Pais Vasco
Spain	Novartis Investigative Site	Elche	Alicante
Spain	Novartis Investigative Site	Granada	Andalucia
Spain	Novartis Investigative Site	Hospitalet de LLobregat	Catalunya
Spain	Novartis Investigative Site	La Coruna	Galicia
Spain	Novartis Investigative Site	La Laguna	Santa Cruz De Tenerife
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Salamanca	Castilla Y Leon
Spain	Novartis Investigative Site	San Sebastian	Pais Vasco
Spain	Novartis Investigative Site	Santander	Cantabria
Spain	Novartis Investigative Site	Santiago de Compostela	Galicia
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Zaragoza
Sweden	Novartis Investigative Site	Göteborg
Sweden	Novartis Investigative Site	Huddinge
Sweden	Novartis Investigative Site	Lulea
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Örebro
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Sundsvall
Sweden	Novartis Investigative Site	Umeå
Sweden	Novartis Investigative Site	Uppsala
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Turkey	Novartis Investigative Site	Adana
United Kingdom	Novartis Investigative Site	Glasgow - Scotland
United States	University of North Carolina UNC Lineberger Cancer Center	Chapel Hill	North Carolina
United States	Missouri Cancer Associates Dept. of Boone Hospital Center	Columbia	Missouri
United States	Rocky Mountain Cancer Centers RMCC - Colorado Springs	Greenwood Village	Colorado
United States	University of Iowa Hospitals and Clinics Dept.of U of Iowa Hosp&Clinics	Iowa City	Iowa
United States	Tennessee Oncology Dept. of Centennial Medical	Nashville	Tennessee
United States	Kansas City Cancer Center KCCC Business Office	Overland Park	Kansas
United States	Hematology Oncology Consultants, Inc. Deptof Hem. Onc.Consunsultants	Saint Louis	Missouri
United States	Kaiser Permanente - California Northern Kaiser Med	Vallejo	California
United States	Wake Forest University Health Sciences Dept. of Industry Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Colombia,  Czechia,  Denmark,  Egypt,  Finland,  France,  Germany,  Italy,  Japan,  Poland,  Russian Federation,  Singapore,  Spain,  Sweden,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the efficacy (MMR rate at 12 months) of nilotinib at 400mg/300mg BID with that of Gleevec/Glivec 400 mg QD in newly diagnosed, previously untreated Philadelphia chromosome-positive CML-CP patients.		12 months
Secondary	To compare the rate of durable MMR at 24 months, which is defined as the proportion of patients who have achieved MMR by 12 months, and also maintain continuous MMR until the 24 month timepoint.		24 months