Know Cancer

or
forgot password

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)


Phase 3
18 Years
70 Years
Not Enrolling
Both
Chronic Myelogenous Leukemia

Thank you

Trial Information

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)

Inclusion Criteria


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 that have not consented to amendment 5

- Patients not completing amendment 5 protocol

Additional protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Survival

Outcome Time Frame:

end of trial - Jan 2012

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CSTI571A 0106

NCT ID:

NCT00333840

Start Date:

June 2000

Completion Date:

March 2012

Related Keywords:

  • Chronic Myelogenous Leukemia
  • CML
  • STI571
  • imatinib
  • interferon
  • interferon alpha
  • cytosine arabinoside
  • chronic myeloid leukemia
  • Philadelphia chromosome positive
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome

Name

Location

Novartis Investigative SiteNew Brunswick, New Jersey  08901
Novartis Investigative SiteChicago, Illinois  60612
Novartis Investigative SiteSouthfield, Michigan  48075
Novartis Investigative SitePortland, Oregon  97239
Novartis Investigative siteNashville, Tennessee  37232
Novartis Investigative SiteSpokane, Washington  99202
Novartis Investigative SiteBoston, Massachusetts  02115
Novartis Investigative SitePhiladelphia, Pennsylvania  19111-2497
Novartis Investigative SiteSacramento, California  95817
Novartis Investigative SiteSt. Louis, Missouri  63110
Novartis Investigative SiteBuffalo, New York  14263
Novartis Investigative SiteDurham, North Carolina  27710
Novartis Investigative SiteCleveland, Ohio  44195
Novartis Investigative SiteMadison, Wisconsin  53792
Novartis Investigative SiteBirmingham, Alabama  35294
Novartis Investigative SiteTucson, Arizona  85724
Novartis Investigative SiteDenver, Colorado  80218
Novartis Investigative SiteMiami, Florida  33176-2197
Novartis Investigative SiteAtlanta, Georgia  30342
Novartis Investigative SiteHonolulu, Hawaii  96813
Novartis Investigative SiteBeech Grove, Indiana  46107
Novartis Investigative SiteWitchita, Kansas  67214
Novartis Investigative SiteLouisville, Kentucky  40202
Novartis Investigative SiteNew Orleans, Louisiana  70112
Novartis Investigative SiteBaltimore, Maryland  21201
Novartis Investigative SiteMinneapolis, Minnesota  55455
Novartis Investigative SiteBillings, Montana  59101
Novartis Investigative SiteOmaha, Nebraska  68198-7681
Novartis Investigative SiteAlburquerque, New Mexico  87109
Novartis Investigative SiteTulsa, Oklahoma  74136
Novartis Investigative SiteProvidence, Rhode Island  02903
Novartis Investigative SiteSpartanburg, South Carolina  29303
Novartis Investigative SiteDallas, Texas  75235-9179
Novartis Investigative SiteSalt Lake City, Utah  84112