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

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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Myelogenous Leukemia
• Intervention / Treatment: Drug: imatinib mesilate; Drug: interferon-alpha (INF-a); Drug: cytarabine (ARA-C)

• Study Type: Interventional
• Enrollment (Actual): 1106
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • 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, 2050
    • Novartis Investigative Site
  • Westmead, Australia
    • Novartis Investigative Site
• Austria
  • Wien, Austria, 1090
    • Novartis Investigative Site
• Belgium
  • Bruxelles, Belgium, 1200
    • Novartis Investigative Site
  • Bruxelles, Belgium, 1000
    • Novartis Investigative Site
  • Godinne, Belgium
    • Novartis Investigative Site
  • Leuven, Belgium, 3000
    • Novartis Investigative Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Novartis Investigative Site
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Novartis Investigative Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Novartis Investigative Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Novartis Investigative Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Novartis Investigative Site
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Novartis Investigative Site
    • London, Ontario, Canada, N6A 4G5
      • Novartis Investigative Site
    • Ottawa, Ontario, Canada, K1H 8L6
      • Novartis Investigative Site
    • Toronto, Ontario, Canada, M5G 2M9
      • Novartis Investigative Site
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Novartis Investigative Site
    • Montreal, Quebec, Canada, H3A 1A1
      • Novartis Investigative Site
• Denmark
  • Arhus, Denmark, 8000
    • Novartis Investigative Site
  • Copenhagen, Denmark
    • Novartis Investigative Site
  • Herlev, Denmark, 2730
    • Novartis Investigative Site
• France
  • Creteil, France, 94010
    • Novartis Investigative Site
  • Lille, France, 59037
    • Novartis Investigative Site
  • Lyon, France, 69437
    • Novartis Investigative Site
  • Marseille, France, 13273
    • Novartis Investigative Site
  • Nantes, France, 44035
    • Novartis Investigative Site
  • Paris, France, 75475
    • Novartis Investigative Site
  • Pessac, France, 33604
    • Novartis Investigative Site
  • Poitiers, France
    • Novartis Investigative Site
  • Strasbourg, France, 67098
    • Novartis Investigative Site
  • Vandoeuvre-les-Nancy, France, 54511
    • Novartis Investigative Site
• Germany
  • Berlin, Germany, 13353
    • Novartis Investigative Site
  • Dresden, Germany, 01307
    • Novartis Investigative Site
  • Dusseldorf, Germany, 40225
    • Novartis Investigative Site
  • Frankfurt, Germany, 60590
    • Novartis Investigative Site
  • Freiburg, Germany, 79106
    • Novartis Investigative Site
  • Hamburg, Germany, 20246
    • Novartis Investigative Site
  • Heidelberg, Germany, 69115
    • Novartis Investigative Site
  • Leipzig, Germany, 04103
    • Novartis Investigative Site
  • Mainz, Germany, 55101
    • Novartis Investigative Site
  • Mannheim, Germany, 68189
    • Novartis Investigative Site
  • Marburg, Germany, 35037
    • Novartis Investigative Site
  • Muenchen, Germany, 80804
    • Novartis Investigative Site
  • Munchen, Germany, 81675
    • Novartis Investigative Site
  • Regensburg, Germany, 93042
    • Novartis Investigative Site
  • Rostock, Germany, 18057
    • Novartis Investigative Site
  • Stuttgart, Germany, 70376
    • Novartis Investigative Site
• Italy
  • Bari, Italy, 70124
    • Novartis Investigative Site
  • Bologna, Italy, 40138
    • Novartis Investigative Site
  • Firenze, Italy, 50134
    • Novartis Investigative Site
  • Genova, Italy, 16132
    • Novartis Investigative Site
  • Milano, Italy, 20162
    • Novartis Investigative Site
  • Napoli, Italy, 80131
    • Novartis Investigative Site
  • Orbassano, Italy, 10043
    • Novartis Investigative Site
  • Pavia, Italy, 27100
    • Novartis Investigative Site
  • Pescara, Italy, 65124
    • Novartis Investigative Site
  • Pisa, Italy, 56126
    • Novartis Investigative Site
  • Reggio Calabria, Italy, 89123
    • Novartis Investigative Site
• Netherlands
  • Amsterdam, Netherlands, 1081HV
    • Novartis Investigative Site
  • Rotterdam, Netherlands
    • Novartis Investigative Site
• New Zealand
  • Auckland, New Zealand
    • Novartis Investigative Site
• Norway
  • Oslo, Norway, 27
    • Novartis Investigative Site
  • Tromso, Norway, 9038
    • Novartis Investigative Site
• Spain
  • Barcelona, Spain, 8025
    • Novartis Investigative Site
  • Barcelona, Spain, 8036
    • Novartis Investigative Site
  • Barcelona, Spain, 8907
    • Novartis Investigative Site
  • Madrid, Spain, 28034
    • Novartis Investigative Site
  • Madrid, Spain, 28222
    • Novartis Investigative Site
  • Madrid, Spain, 46010
    • Novartis Investigative Site
  • Salamanca, Spain, 37007
    • Novartis Investigative Site
  • Valencia, Spain, 46010
    • Novartis Investigative Site
• Sweden
  • Goteborg, Sweden, 143 45
    • Novartis Investigative Site
  • Linkoping, Sweden, 581 85
    • Novartis Investigative Site
  • Lund, Sweden, 221 85
    • Novartis Investigative Site
  • Orebro, Sweden, 70 185
    • Novartis Investigative Site
  • Stockholm, Sweden, 141 86
    • Novartis Investigative Site
  • Stockholm, Sweden, 171 76
    • Novartis Investigative Site
  • Umea, Sweden, 901 85
    • Novartis Investigative Site
  • Uppsala, Sweden, 751 85
    • Novartis Investigative Site
• Switzerland
  • Basel, Switzerland, 4031
    • Novartis Investigative Site
  • Bern, Switzerland, 3010
    • Novartis Investigative Site
  • St. Gallen, Switzerland, 9007
    • Novartis Investigative Site
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Novartis Investigative Site
  • Cambridge, United Kingdom, CB2 2XY
    • Novartis Investigative Site
  • Cardiff, United Kingdom, CF14 4XN
    • Novartis Investigative Site
  • Leeds, United Kingdom, LS1 3EX
    • Novartis Investigative Site
  • Liverpool, United Kingdom, L7 8XP
    • Novartis Investigative Site
  • London, United Kingdom, EC1A 7BE
    • Novartis Investigative Site
  • London, United Kingdom, SE5 9RS
    • Novartis Investigative Site
  • Manchester, United Kingdom, M13 9WL
    • Novartis Investigative Site
  • Nottingham, United Kingdom, NG5 1PB
    • Novartis Investigative Site
  • Plymouth, United Kingdom
    • Novartis Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Novartis Investigative Site
    • Montgomery, Alabama, United States, 36106
      • Novartis Investigative Site
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Novartis Investigative Site
  • California
    • Berkeley, California, United States, 94704
      • Novartis Investigative Site
    • Campbell, California, United States, 95008
      • Novartis Investigative Site
    • Duarte, California, United States, 91010
      • Novartis Investigative Site
    • La Jolla, California, United States, 92093-0960
      • Novartis Investigative Site
  • Colorado
    • Denver, Colorado, United States, 80218
      • Novartis Investigative Site
  • Florida
    • Miami, Florida, United States, 33176-2197
      • Novartis Investigative Site
    • Orlando, Florida, United States, 32804
      • Novartis Investigative Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Novartis Investigative Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Novartis Investigative Site
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Novartis Investigative Site
    • Chicago, Illinois, United States, 60611
      • Novartis Investigative Site
    • Chicago, Illinois, United States, 60637
      • Novartis Investigative Site
    • Decatur, Illinois, United States, 62526
      • Novartis Investigative Site
  • Indiana
    • Beech Grove, Indiana, United States, 46107
      • Novartis Investigative Site
  • Kansas
    • Witchita, Kansas, United States, 67214
      • Novartis Investigative Site
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Novartis Investigative Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Novartis Investigative Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Novartis Investigative Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Novartis Investigative Site
    • Worcester, Massachusetts, United States, 01665
      • Novartis Investigative Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Novartis Investigative Site
    • Detroit, Michigan, United States, 48202-2689
      • Novartis Investigative Site
    • East Lansing, Michigan, United States, 48910
      • Novartis Investigative Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Novartis Investigative Site
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Novartis Investigative Site
  • Montana
    • Billings, Montana, United States, 59101
      • Novartis Investigative Site
  • Nebraska
    • Omaha, Nebraska, United States, 68198-7681
      • Novartis Investigative Site
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Novartis Investigative Site
  • New Mexico
    • Alburquerque, New Mexico, United States, 87109
      • Novartis Investigative Site
    • Alburquerque, New Mexico, United States, 87131
      • Novartis Investigative Site
    • Farmington, New Mexico, United States, 87131
      • Novartis Investigative Site
  • New York
    • Buffalo, New York, United States, 14263
      • Novartis Investigative Site
    • New York, New York, United States, 10029
      • Novartis Investigative Site
    • New York, New York, United States, 10021
      • Novartis Investigative Site
    • New York, New York, United States, 10017
      • Novartis Investigative Site
    • Syracuse, New York, United States, 13210
      • Novartis Investigative Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Novartis Investigative Site
    • Charlotte, North Carolina, United States, 28203
      • Novartis Investigative Site
    • Durham, North Carolina, United States, 27710
      • Novartis Investigative Site
    • Winston-Salem, North Carolina, United States, 27157
      • Novartis Investigative Site
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Novartis Investigative Site
    • Columbus, Ohio, United States, 43210
      • Novartis Investigative Site
    • Columbus, Ohio, United States, 43215
      • Novartis Investigative Site
    • Dayton, Ohio, United States, 45429
      • Novartis Investigative Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Novartis Investigative Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • Novartis Investigative Site
  • Pennsylvania
    • Pittsburg, Pennsylvania, United States, 15224
      • Novartis Investigative Site
    • Pittsburg, Pennsylvania, United States, 15232
      • Novartis Investigative Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Novartis Investigative Site
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Novartis Investigative Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Novartis Investigative Site
    • Nashville, Tennessee, United States, 37203
      • Novartis Investigative Site
    • Nashville, Tennessee, United States, 37205
      • Novartis Investigative Site
  • Texas
    • Dallas, Texas, United States, 75246
      • Novartis Investigative Site
    • Dallas, Texas, United States, 75235-9179
      • Novartis Investigative Site
    • Houston, Texas, United States, 77030
      • Novartis Investigative Site
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Novartis Investigative Site
  • Washington
    • Seattle, Washington, United States, 98109-1024
      • Novartis Investigative Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: imatinib (STI571); In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injection for 10 days every month. Maximum study duration was 11.5 years.	Drug: imatinib mesilate; imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules.; Other Names: Glivec®; STI571; Gleevec®; Drug: 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.; Other Names: Roferon®-A; Intron®-A; Drug: cytarabine (ARA-C); cytarabine 20 mg/m^2/day (max 40 mg) SC for 10 days every month.
Active Comparator: IFN-a+Ara-C; In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.	Drug: imatinib mesilate; imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules.; Other Names: Glivec®; STI571; Gleevec®; Drug: 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.; Other Names: Roferon®-A; Intron®-A; Drug: cytarabine (ARA-C); cytarabine 20 mg/m^2/day (max 40 mg) SC for 10 days every month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Jain P, Kantarjian H, Nazha A, O'Brien S, Jabbour E, Romo CG, Pierce S, Cardenas-Turanzas M, Verstovsek S, Borthakur G, Ravandi F, Quintas-Cardama A, Cortes J. Early responses predict better outcomes in patients with newly diagnosed chronic myeloid leukemia: results with four tyrosine kinase inhibitor modalities. Blood. 2013 Jun 13;121(24):4867-74. doi: 10.1182/blood-2013-03-490128. Epub 2013 Apr 25.
• Hochhaus A, Larson RA, Guilhot F, Radich JP, Branford S, Hughes TP, Baccarani M, Deininger MW, Cervantes F, Fujihara S, Ortmann CE, Menssen HD, Kantarjian H, O'Brien SG, Druker BJ; IRIS Investigators. Long-Term Outcomes of Imatinib Treatment for Chronic Myeloid Leukemia. N Engl J Med. 2017 Mar 9;376(10):917-927. doi: 10.1056/NEJMoa1609324.
• Larson RA, Druker BJ, Guilhot F, O'Brien SG, Riviere GJ, Krahnke T, Gathmann I, Wang Y; IRIS (International Randomized Interferon vs STI571) Study Group. Imatinib pharmacokinetics and its correlation with response and safety in chronic-phase chronic myeloid leukemia: a subanalysis of the IRIS study. Blood. 2008 Apr 15;111(8):4022-8. doi: 10.1182/blood-2007-10-116475. Epub 2008 Feb 6.

Study record dates

Study Major Dates

• Study Start: June 1, 2000
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: June 2, 2006
• First Submitted That Met QC Criteria: June 2, 2006
• First Posted (Estimate): June 6, 2006

Study Record Updates

• Last Update Posted (Estimate): October 14, 2013
• Last Update Submitted That Met QC Criteria: August 7, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: interferon; CML; chronic myeloid leukemia; STI571; imatinib; interferon alpha; Philadelphia chromosome positive; cytosine arabinoside
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Chromosome Aberrations; Translocation, Genetic; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protein Kinase Inhibitors; Interferons; Interferon-alpha; Interferon alpha-2; Cytarabine; Imatinib Mesylate
• Other Study ID Numbers: CSTI571A 0106