CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 532 enrolled
Drug / intervention
STI571drug
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML)
  • ✓Documented failure of interferon-alpha (IFN) or IFN-containing therapy, characterized as resistance or refractoriness
  • ✓Hematologic resistance: failure to achieve complete hematological response (CHR) lasting ≥1 month despite ≥6 months of IFN at ≥25 MIU/week (with hydroxyurea ≤50% of treatment period)
  • ✓Cytogenetic resistance: ≥65% Ph+ after one year of IFN-based therapy
Key exclusion· 7
  • ✕Serum bilirubin or creatinine >2 × ULN
  • ✕SGOT or SGPT >2 × ULN
  • ✕>15% blasts or basophils in peripheral blood or bone marrow
  • ✕≥30% blasts plus promyelocytes in peripheral blood or bone marrow

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00171223
NCT00171223Phase 2Completed
CompareCT.gov

An Extension to a Phase II Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia Who Are Refractory to or Intolerant of Interferon-Alpha

Novartis Pharmaceuticals·interventional·Posted Sep 15, 2005·Updated Jul 22, 2021

In Brief

A Phase 2 clinical trial evaluating STI571 for Leukemia, Myelogenous, Chronic, BCR-ABL Positive. Completed, enrolled 532 participants across 28 sites in 6 countries.

Detailed Summary

During the Core Phase of the study, participants received STI571 at a dose of 400 milligrams (mg) daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study provided that, in the opinion of the investigator, they had benefited from treatment with STI571 and there were no safety concerns.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myelogenous, Chronic, BCR-ABL Positive
CountriesFrance, Germany, Italy, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartDec 6, 1999
Primary CompletionNov 29, 2013
TodayJul 2, 2026
Enrollment to primary: 14.0 yearsPosted 20.8 years ago

Interventions

STI571drug

STI571 oral capsules or tablets.