CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 260 enrolled
Drug / intervention
imatinib mesylatedrug
Likely dose
Imatinib mesylate (dose not specified in arms/interventions)AI-extracted
Key inclusion· 5
  • ✓Philadelphia chromosome-positive CML in myeloid blast crisis with ≥30% blasts in peripheral blood and/or bone marrow, or blast crisis by flow cytometry criteria
  • ✓Newly diagnosed patients must not have received specific CML accelerated or blast phase therapy except interferon-alpha or hydroxyurea
  • ✓SGOT and SGPT ≤3× ULN (or ≤5× ULN if hepatic leukemic involvement suspected)
  • ✓Serum creatinine ≤2× ULN
Key exclusion· 4
  • ✕ECOG performance status ≥3
  • ✕Grade 3/4 cardiac disease or other serious concurrent medical conditions
  • ✕Hematopoietic stem cell transplantation within 6 weeks of Day 1
  • ✕Investigational agents within 28 days of Day 1

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

Search/NCT00171158
NCT00171158Phase 2Completed
CompareCT.gov

An Extension to a Phase II Open-label Study to Determine the Safety and Anti-leukemic Effects of STI571 in Patients With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Myeloid Blast Crisis

Novartis Pharmaceuticals·interventional·Posted Sep 15, 2005·Updated Jun 25, 2021

In Brief

A Phase 2 clinical trial evaluating imatinib mesylate for Philadelphia Chromosome Positive CML. Completed, enrolled 260 participants across 10 sites in 4 countries.

Detailed Summary

This extension II study allowed for further follow-up of the disease under treatment with imatinib mesylate and allow the participants to continue to receive imatinib mesylate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhiladelphia Chromosome Positive CML
CountriesFrance, Germany, Italy, United States
Collaborators--

Timeline

Phase 2CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartJul 26, 1999
Primary CompletionApr 1, 2013
Study CompletionApr 22, 2013
TodayJul 2, 2026
Enrollment to primary: 13.7 yearsPosted 20.8 years ago

Interventions

imatinib mesylatedrug