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NCT00333840 Clinical Trial

Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

Chronic Myelogenous Leukemia Clinical Trial

Official title:
A Phase III Study of STI571 Versus Interferon-α (IFN-α) Combined With Cytarabine (Ara-C) in Patients With Newly Diagnosed Previously Untreated Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00333840
Other study ID # CSTI571A 0106
Secondary ID
Status Completed
Phase Phase 3
First received June 2, 2006
Last updated August 7, 2013
Start date June 2000
Est. completion date March 2012

Study information
Verified date August 2013
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationEuropean Union: European Medicines AgencyAustralia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate and compare the side effects and anti-leukemic benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid leukemia (CML) in the chronic phase. Patients in this study will be randomized (1:1) to receive either interferon plus Ara-C or imatinib as initial treatment.

Recruitment information / eligibility
Status Completed
Enrollment 1106
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion criteria:

- Must have signed consent for Amendment 5

- Must have completed visit 62 of the core IRIS trial or be in follow-up

- Must be on STI571 treatment

- If on IFN treatment, must be willing to cross over to STI571 treatment

Exclusion criteria:

- Patients who have discontinued from the study and are in follow-up

- Patients who are on IFN treatment and do not want to cross over to STI571 treatment

- Patients who have not consented to amendment 5

- Patients who did not complete the amendment 5 protocol

Additional protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• imatinib mesilate
imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules.
• interferon-alpha (INF-a)
interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day.
• cytarabine (ARA-C)
cytarabine 20 mg/m^2/day (max 40 mg) SC for 10 days every month.

Locations
Country Name City State
Australia Novartis Investigative Site Adelaide
Australia Novartis Investigative Site Brisbane
Australia Novartis Investigative Site Darlinghurst
Australia Novartis Investigative Site East Melbourne
Australia Novartis Investigative Site Nedlands
Australia Novartis Investigative Site Parkville
Australia Novartis Investigative Site Prahan
Australia Novartis Investigative Site South Brisbane
Australia Novartis Investigative Site St. Leonards
Australia Novartis Investigative Site Sydney
Australia Novartis Investigative Site Westmead
Austria Novartis Investigative Site Wien
Belgium Novartis Investigative Site Bruxelles
Belgium Novartis Investigative Site Bruxelles
Belgium Novartis Investigative Site Godinne
Belgium Novartis Investigative Site Leuven
Canada Novartis Investigative Site Calgary Alberta
Canada Novartis Investigative Site Edmonton Alberta
Canada Novartis Investigative Site Halifax Nova Scotia
Canada Novartis Investigative Site Hamilton Ontario
Canada Novartis Investigative Site London Ontario
Canada Novartis Investigative Site Montreal Quebec
Canada Novartis Investigative Site Montreal Quebec
Canada Novartis Investigative Site Ottawa Ontario
Canada Novartis Investigative Site Toronto Ontario
Canada Novartis Investigative Site Vancouver British Columbia
Canada Novartis Investigative Site Winnipeg Manitoba
Denmark Novartis Investigative Site Arhus
Denmark Novartis Investigative Site Copenhagen
Denmark Novartis Investigative Site Herlev
France Novartis Investigative Site Creteil
France Novartis Investigative Site Lille
France Novartis Investigative Site Lyon
France Novartis Investigative Site Marseille
France Novartis Investigative Site Nantes
France Novartis Investigative Site Paris
France Novartis Investigative Site Pessac
France Novartis Investigative Site Poitiers
France Novartis Investigative Site Strasbourg
France Novartis Investigative Site Vandoeuvre-les-Nancy
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Dresden
Germany Novartis Investigative Site Dusseldorf
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Freiburg
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Heidelberg
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Mainz
Germany Novartis Investigative Site Mannheim
Germany Novartis Investigative Site Marburg
Germany Novartis Investigative Site Muenchen
Germany Novartis Investigative Site Munchen
Germany Novartis Investigative Site Regensburg
Germany Novartis Investigative Site Rostock
Germany Novartis Investigative Site Stuttgart
Italy Novartis Investigative Site Bari
Italy Novartis Investigative Site Bologna
Italy Novartis Investigative Site Firenze
Italy Novartis Investigative Site Genova
Italy Novartis Investigative Site Milano
Italy Novartis Investigative Site Napoli
Italy Novartis Investigative Site Orbassano
Italy Novartis Investigative Site Pavia
Italy Novartis Investigative Site Pescara
Italy Novartis Investigative Site Pisa
Italy Novartis Investigative Site Reggio Calabria
Netherlands Novartis Investigative Site Amsterdam
Netherlands Novartis Investigative Site Rotterdam
New Zealand Novartis Investigative Site Auckland
Norway Novartis Investigative Site Oslo
Norway Novartis Investigative Site Tromso
Spain Novartis Investigative Site Barcelona
Spain Novartis Investigative Site Barcelona
Spain Novartis Investigative Site Barcelona
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Salamanca
Spain Novartis Investigative Site Valencia
Sweden Novartis Investigative Site Goteborg
Sweden Novartis Investigative Site Linkoping
Sweden Novartis Investigative Site Lund
Sweden Novartis Investigative Site Orebro
Sweden Novartis Investigative Site Stockholm
Sweden Novartis Investigative Site Stockholm
Sweden Novartis Investigative Site Umea
Sweden Novartis Investigative Site Uppsala
Switzerland Novartis Investigative Site Basel
Switzerland Novartis Investigative Site Bern
Switzerland Novartis Investigative Site St. Gallen
United Kingdom Novartis Investigative Site Birmingham
United Kingdom Novartis Investigative Site Cambridge
United Kingdom Novartis Investigative Site Cardiff
United Kingdom Novartis Investigative Site Leeds
United Kingdom Novartis Investigative Site Liverpool
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site Manchester
United Kingdom Novartis Investigative Site Nottingham
United Kingdom Novartis Investigative Site Plymouth
United States Novartis Investigative Site Alburquerque New Mexico
United States Novartis Investigative Site Alburquerque New Mexico
United States Novartis Investigative Site Ann Arbor Michigan
United States Novartis Investigative Site Atlanta Georgia
United States Novartis Investigative Site Baltimore Maryland
United States Novartis Investigative Site Beech Grove Indiana
United States Novartis Investigative Site Berkeley California
United States Novartis Investigative Site Billings Montana
United States Novartis Investigative Site Birmingham Alabama
United States Novartis Investigative Site Boston Massachusetts
United States Novartis Investigative Site Buffalo New York
United States Novartis Investigative Site Campbell California
United States Novartis Investigative Site Chapel Hill North Carolina
United States Novartis Investigative Site Charlotte North Carolina
United States Novartis Investigative Site Chicago Illinois
United States Novartis Investigative Site Chicago Illinois
United States Novartis Investigative Site Chicago Illinois
United States Novartis Investigative Site Cleveland Ohio
United States Novartis Investigative Site Columbus Ohio
United States Novartis Investigative Site Columbus Ohio
United States Novartis Investigative Site Dallas Texas
United States Novartis Investigative Site Dallas Texas
United States Novartis Investigative Site Dayton Ohio
United States Novartis Investigative Site Decatur Illinois
United States Novartis Investigative Site Denver Colorado
United States Novartis Investigative Site Detroit Michigan
United States Novartis Investigative Site Duarte California
United States Novartis Investigative Site Durham North Carolina
United States Novartis Investigative Site East Lansing Michigan
United States Novartis Investigative Site Farmington New Mexico
United States Novartis Investigative Site Hackensack New Jersey
United States Novartis Investigative Site Honolulu Hawaii
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site La Jolla California
United States Novartis Investigative Site Louisville Kentucky
United States Novartis Investigative Site Memphis Tennessee
United States Novartis Investigative Site Miami Florida
United States Novartis Investigative Site Milwaukee Wisconsin
United States Novartis Investigative Site Minneapolis Minnesota
United States Novartis Investigative Site Montgomery Alabama
United States Novartis Investigative Site Nashville Tennessee
United States Novartis Investigative Site Nashville Tennessee
United States Novartis Investigative Site New Orleans Louisiana
United States Novartis Investigative Site New York New York
United States Novartis Investigative Site New York New York
United States Novartis Investigative Site New York New York
United States Novartis Investigative Site Omaha Nebraska
United States Novartis Investigative Site Orlando Florida
United States Novartis Investigative Site Pittsburg Pennsylvania
United States Novartis Investigative Site Pittsburg Pennsylvania
United States Novartis Investigative Site Portland Oregon
United States Novartis Investigative Site Providence Rhode Island
United States Novartis Investigative Site Salt Lake City Utah
United States Novartis Investigative Site Seattle Washington
United States Novartis Investigative Site Spartanburg South Carolina
United States Novartis Investigative Site St. Louis Missouri
United States Novartis Investigative Site Syracuse New York
United States Novartis Investigative Site Tucson Arizona
United States Novartis Investigative Site Tulsa Oklahoma
United States Novartis Investigative Site Winston-Salem North Carolina
United States Novartis Investigative Site Witchita Kansas
United States Novartis Investigative Site Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Denmark,  France,  Germany,  Italy,  Netherlands,  New Zealand,  Norway,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Kaplan-Meier Estimates of Overall Survival (All Randomized Participants) Overall survival was defined as the time between date of randomization and death due to any cause. The time was censored at last examination date for patients who were still being treated and at date of last contact for patients who discontinued treatment. Kaplan-Meier estimates of the percentage of participants at each time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment. 12,24,36,48,60,72,84,96,108,120,132 and 144 months No
Secondary Kaplan Meier Estimates of Event Free Survival (All Randomized Participants) Event-free survival is defined as the time between randomization and the earliest of any of the following events on treatment:
progression to Accelerated Phase (AP) or Blast Crisis (BC)
loss of Complete Hematological Response (CHR)
loss of Major Cytogenetic Response (MCyR) confirmed
loss of Major Cytogenetic Response (MCyR) unconfirmed
increase in white blood cell count (WBC) if approved by the Study Management Committee (SMC)
death (due to any cause when reported as primary reason for discontinuation of treatment).
Kaplan Meier estimates of the percentage of participants with Event Free Survival at the given time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.		 12,24,36,48,60,72,84,96,108,120,132 and 144 months No
Secondary Percentage of Participants With Event Free Survival Events (All Randomized Participants) Event-free survival is defined as the time between randomization and the earliest of any of the following events on treatment:
progression to Accelerated Phase (AP) or Blast Crisis (BC)
loss of Complete Hematological Response (CHR)
loss of Major Cytogenic Response (MCyR) confirmed
loss of Major Cytogenic Response (MCyR) unconfirmed
increase in white blood cell count (WBC) if approved by the Study Management Committee (SMC)
death (due to any cause when reported as primary reason for discontinuation of treatment).
The percentage of participants with Event Free Survival events in each category was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.		 144 months No
Secondary Kaplan Meier Estimates of Time to Progression to Accelerated Phase (AP) or Blast Crisis (BC) (All Randomized Participants) Time to progression to AP/BC is defined as the time between randomization and either of the following events on treatment: death (due to CML when reported as primary reason for discontinuation of treatment) or progression to Accelerated Phase or Blast Crisis and is censored at last examination date for patients without event. No data after discontinuation of study treatment was included. The Kaplan Meier estimates of the percentage of participants with survival without progression to AP/BC at the given time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment. 12,24,36,48,60,72,84,96,108,120,132 and 144 months No
Secondary Percentage of Participants With Best Cytogenetic Response (First-line Treatment) Bone marrow aspirate was performed to evaluate cytogenetic results (percentage of Philadelphia chromosome positive (Ph+) metaphases) and amount of blasts and promyelocytes in bone marrow to establish cytogenetic response.
Major Cytogenetic Response= Complete Response or Partial Response. Complete Cytogenetic Response= 0 % of Ph+ metaphases (out of 20 metaphases). Partial Cytogenetic Response= > 0 and = 35 % of Ph+ metaphases (out of 20 metaphases). The percentage of participants with cytogenetic response in each category was calculated.		 144 months No
Secondary Percentage of Participants With Best Cytogenetic Response (Second-line Treatment) Bone marrow aspirate was performed to evaluate cytogenetic results (percentage of Ph chromosome (Ph+) containing metaphases) and the amount of blasts and promyelocytes in bone marrow to establish cytogenetic response.
Major Cytogenetic Response= Complete Response or Partial Response. Complete Cytogenetic Response= 0 % of Ph+ metaphases (out of 20 metaphases). Partial Cytogenetic Response= > 0 and = 35 % Ph+ metaphases (out of 20 metaphases). The percentage of participants with cytogenetic response in each category was calculated.		 144 months No
Secondary Number of Participants With Serious Adverse Events as a Measure of Safety (First-line Treatment) A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant 144 months Yes
Secondary Number of Participants With Serious Adverse Events as a Measure of Safety (Second-line Treatment) A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant 144 months Yes
Secondary Percentage of Participants With Major Molecular Response (First-line Treatment) Major Molecular Response was determined using a quantitative polymerase chain reaction (PCR) laboratory test and was defined as BCR-ABL protein transcripts of = 0.1% according to the international scale. 12,24,36,48,60,72,84,96,108,120,132 and 144 months No
Secondary Percentage of Participants With Major Molecular Response (Second-line Treatment) Major Molecular Response was determined using a quantitative polymerase chain reaction (PCR) laboratory test and was defined as BCR-ABL protein transcripts of = 0.1% according to the international scale. 12,24,36,48,60,72,84,96,108,120,132 and 144 months No
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