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A Phase III Study Comparing Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day) in the Treatment of Newly Diagnosed High Risk Chronic Myeloid Leukemia in Chronic Phase


Phase 3
18 Years
N/A
Not Enrolling
Both
Chronic Myeloid Leukemia

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Trial Information

A Phase III Study Comparing Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day) in the Treatment of Newly Diagnosed High Risk Chronic Myeloid Leukemia in Chronic Phase


Inclusion Criteria:



1. Age >/=18 years

2. First chronic phase, less than 6 months of duration

3. High Sokal's risk

4. Ph positive

5. No previous treatment or hydroxiurea only.

6. Performance status (ECOG/WHO) < 2

7. Written informed consent

Exclusion Criteria:

1. Age <18

2. Low or intermediate Sokal risk score.

3. More than 6 months from diagnosis.

4. Second chronic, accelerated or blastic phase

5. Scheduled allogeneic stem cell transplantation within 1 year from diagnosis.

6. Performance status (ECOG/WHO) > 2

7. Inability to provide written informed consent

8. Pregnancy

9. Formal refusal of any recommendation of a safe contraception

10. Alcohol or drug addiction

11. Altered hepatic or renal function as defined by AST/ALT or bilirubine > 3 times upper
normal limits (UNL) and by creatinine > 20mg/L

12. Any other disease or condition that by the advise of the responsible physician would
make the treatment dangerous for the patient or would make the patient ineligible for
the study, including physical, psychiatric, social and behavioural problems.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

To determine the rate of complete cytogenetic response at 12 months in adult patients with previously untreated high Sokal risk CML treated with imatinib at 2 different dose levels of 400 and 800 mg/daily.

Principal Investigator

Michele Baccarani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna

Authority:

Italy: The Italian Medicines Agency

Study ID:

ICSG/CML022

NCT ID:

NCT00514488

Start Date:

June 2004

Completion Date:

Related Keywords:

  • Chronic Myeloid Leukemia
  • chronic myeloid leukemia
  • STI 571
  • CML022
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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