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Completed

NCT Number: NCT00514488

Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day)

This is a phase III multicenter, open-label study designed to investigate the efficacy (hematological response, cytogenetic response and molecular response) and feasibility (tolerance, compliance and safety) of the tyrosine kinase inhibitor imatinib mesylate (formerly STI 571, GLIVEC, Novartis Pharma) at conventional dose (400 mg/daily) if compared with high dose (800 mg/daily) (serial number protocol ICSG/CML/022) in patients with Ph+ chronic myeloid leukemia (CML) in chronic phase (CP) previously untreated, at high Sokal risk.

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli"

Bologna, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >/=18 years
  • First chronic phase, less than 6 months of duration
  • High Sokal's risk
  • Ph positive
  • No previous treatment or hydroxiurea only.
  • Performance status (ECOG/WHO) < 2
  • Written informed consent

Exclusion criteria

  • Age <18
  • Low or intermediate Sokal risk score.
  • More than 6 months from diagnosis.
  • Second chronic, accelerated or blastic phase
  • Scheduled allogeneic stem cell transplantation within 1 year from diagnosis.
  • Performance status (ECOG/WHO) > 2
  • Inability to provide written informed consent
  • Pregnancy
  • Formal refusal of any recommendation of a safe contraception
  • Alcohol or drug addiction
  • Altered hepatic or renal function as defined by AST/ALT or bilirubine > 3 times upper normal limits (UNL) and by creatinine > 20mg/L
  • 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.

Treatment and study plan

STI571 (400 mg/day; or 800 mg/day)

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. The rate of major cytogenetic response,the kinetic and duration of cytogenetic response, the time to accelerated and blast crisis and overall survival,safety and tolerability of the treatment.

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Collaborators

  • Novartis

Registry information

Official study title

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

Acronym: CML022

Important dates

Study start
2004
First posted
Aug 10, 2007
Registry last updated
Aug 10, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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