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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 Site New Brunswick, New Jersey  08901
Novartis Investigative Site Chicago, Illinois  60612
Novartis Investigative Site Southfield, Michigan  48075
Novartis Investigative Site Portland, Oregon  97239
Novartis Investigative site Nashville, Tennessee  37232
Novartis Investigative Site Spokane, Washington  99202
Novartis Investigative Site Boston, Massachusetts  02115
Novartis Investigative Site Philadelphia, Pennsylvania  19111-2497
Novartis Investigative Site Sacramento, California  95817
Novartis Investigative Site St. Louis, Missouri  63110
Novartis Investigative Site Buffalo, New York  14263
Novartis Investigative Site Durham, North Carolina  27710
Novartis Investigative Site Cleveland, Ohio  44195
Novartis Investigative Site Madison, Wisconsin  53792
Novartis Investigative Site Birmingham, Alabama  35294
Novartis Investigative Site Tucson, Arizona  85724
Novartis Investigative Site Denver, Colorado  80218
Novartis Investigative Site Miami, Florida  33176-2197
Novartis Investigative Site Atlanta, Georgia  30342
Novartis Investigative Site Honolulu, Hawaii  96813
Novartis Investigative Site Beech Grove, Indiana  46107
Novartis Investigative Site Witchita, Kansas  67214
Novartis Investigative Site Louisville, Kentucky  40202
Novartis Investigative Site New Orleans, Louisiana  70112
Novartis Investigative Site Baltimore, Maryland  21201
Novartis Investigative Site Minneapolis, Minnesota  55455
Novartis Investigative Site Billings, Montana  59101
Novartis Investigative Site Omaha, Nebraska  68198-7681
Novartis Investigative Site Alburquerque, New Mexico  87109
Novartis Investigative Site Tulsa, Oklahoma  74136
Novartis Investigative Site Providence, Rhode Island  02903
Novartis Investigative Site Spartanburg, South Carolina  29303
Novartis Investigative Site Dallas, Texas  75235-9179
Novartis Investigative Site Salt Lake City, Utah  84112