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CompletedNCT00514488CML022Updated Aug 10, 2007

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

A Phase 3 interventional study of STI571 (400 mg/day; or 800 mg/day) in Chronic Myeloid Leukemia, sponsored by University of Bologna. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-08-10.

Sponsored by University of Bologna · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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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Conditions studied

  • Chronic Myeloid Leukemia

Keywords

  • chronic myeloid leukemia
  • STI 571
  • CML022
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In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

Browse Leukemia studies →

Lead sponsor

University of Bologna is the lead sponsor of 153 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)

Interventions

  • DrugSTI571 (400 mg/day; or 800 mg/day)
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What researchers measure

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.

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Study locations

1 site
  • Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli"
    Bologna, Italy
08

References and documents

Publications

  • Gugliotta G, Castagnetti F, Breccia M, Albano F, Iurlo A, Intermesoli T, Abruzzese E, Levato L, D'Adda M, Pregno P, Cavazzini F, Stagno F, Martino B, La Barba G, Sora F, Tiribelli M, Bigazzi C, Binotto G, Bonifacio M, Caracciolo C, Soverini S, Foa R, Cavo M, Martinelli G, Pane F, Saglio G, Baccarani M, Rosti G; Gruppo Italiano Malattie Ematologiche dell'Adulto - Chronic Myeloid Leukemia Working Party. Incidence of second primary malignancies and related mortality in patients with imatinib-treated chronic myeloid leukemia. Haematologica. 2017 Sep;102(9):1530-1536. doi: 10.3324/haematol.2017.169532. Epub 2017 Jun 1. PubMed 28572163 ↗
  • Castagnetti F, Gugliotta G, Baccarani M, Breccia M, Specchia G, Levato L, Abruzzese E, Rossi G, Iurlo A, Martino B, Pregno P, Stagno F, Cuneo A, Bonifacio M, Gobbi M, Russo D, Gozzini A, Tiribelli M, de Vivo A, Alimena G, Cavo M, Martinelli G, Pane F, Saglio G, Rosti G; GIMEMA CML Working Party. Differences among young adults, adults and elderly chronic myeloid leukemia patients. Ann Oncol. 2015 Jan;26(1):185-192. doi: 10.1093/annonc/mdu490. Epub 2014 Oct 30. PubMed 25361995 ↗
  • Luatti S, Castagnetti F, Marzocchi G, Baldazzi C, Gugliotta G, Iacobucci I, Specchia G, Zanatta L, Rege-Cambrin G, Mancini M, Abruzzese E, Zaccaria A, Grimoldi MG, Gozzetti A, Ameli G, Capucci MA, Palka G, Bernasconi P, Palandri F, Pane F, Saglio G, Martinelli G, Rosti G, Baccarani M, Testoni N; Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) Working Party on CML. Additional chromosomal abnormalities in Philadelphia-positive clone: adverse prognostic influence on frontline imatinib therapy: a GIMEMA Working Party on CML analysis. Blood. 2012 Jul 26;120(4):761-7. doi: 10.1182/blood-2011-10-384651. Epub 2012 Jun 12. Erratum In: Blood. 2013 Jun 27;121(26):5259. Cambrin, Rege [corrected to Rege-Cambrin, Giovanna]. PubMed 22692507 ↗
  • Gugliotta G, Castagnetti F, Palandri F, Breccia M, Intermesoli T, Capucci A, Martino B, Pregno P, Rupoli S, Ferrero D, Gherlinzoni F, Montefusco E, Bocchia M, Tiribelli M, Pierri I, Grifoni F, Marzocchi G, Amabile M, Testoni N, Martinelli G, Alimena G, Pane F, Saglio G, Baccarani M, Rosti G; Gruppo Italiano Malattie Ematologiche dell'Adulto CML Working Party. Frontline imatinib treatment of chronic myeloid leukemia: no impact of age on outcome, a survey by the GIMEMA CML Working Party. Blood. 2011 May 26;117(21):5591-9. doi: 10.1182/blood-2010-12-324228. Epub 2011 Mar 30. PubMed 21450900 ↗
  • Marzocchi G, Castagnetti F, Luatti S, Baldazzi C, Stacchini M, Gugliotta G, Amabile M, Specchia G, Sessarego M, Giussani U, Valori L, Discepoli G, Montaldi A, Santoro A, Bonaldi L, Giudici G, Cianciulli AM, Giacobbi F, Palandri F, Pane F, Saglio G, Martinelli G, Baccarani M, Rosti G, Testoni N; Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) Working Party on Chronic Myeloid Leukemia. Variant Philadelphia translocations: molecular-cytogenetic characterization and prognostic influence on frontline imatinib therapy, a GIMEMA Working Party on CML analysis. Blood. 2011 Jun 23;117(25):6793-800. doi: 10.1182/blood-2011-01-328294. Epub 2011 Mar 29. PubMed 21447834 ↗
  • Testoni N, Marzocchi G, Luatti S, Amabile M, Baldazzi C, Stacchini M, Nanni M, Rege-Cambrin G, Giugliano E, Giussani U, Abruzzese E, Kerim S, Grimoldi MG, Gozzetti A, Crescenzi B, Carcassi C, Bernasconi P, Cuneo A, Albano F, Fugazza G, Zaccaria A, Martinelli G, Pane F, Rosti G, Baccarani M. Chronic myeloid leukemia: a prospective comparison of interphase fluorescence in situ hybridization and chromosome banding analysis for the definition of complete cytogenetic response: a study of the GIMEMA CML WP. Blood. 2009 Dec 3;114(24):4939-43. doi: 10.1182/blood-2009-07-229864. Epub 2009 Oct 1. PubMed 19797518 ↗
  • Baccarani M, Rosti G, Castagnetti F, Haznedaroglu I, Porkka K, Abruzzese E, Alimena G, Ehrencrona H, Hjorth-Hansen H, Kairisto V, Levato L, Martinelli G, Nagler A, Lanng Nielsen J, Ozbek U, Palandri F, Palmieri F, Pane F, Rege-Cambrin G, Russo D, Specchia G, Testoni N, Weiss-Bjerrum O, Saglio G, Simonsson B. Comparison of imatinib 400 mg and 800 mg daily in the front-line treatment of high-risk, Philadelphia-positive chronic myeloid leukemia: a European LeukemiaNet Study. Blood. 2009 May 7;113(19):4497-504. doi: 10.1182/blood-2008-12-191254. Epub 2009 Mar 4. PubMed 19264678 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00514488
Lead sponsor
University of Bologna
Collaborators
Novartis
First posted
Aug 10, 2007
Start date
Jun 2004
Last update
Aug 10, 2007

Study contacts

Michele Baccarani, MD
principal investigator · Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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