← Back to Search

Tyrosine Kinase Inhibitor

BMS-354825 vs Imatinib for Chronic Myeloid Leukemia

Phase 2

Waitlist Available

Led By Ronald Paquette, MD

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 5 days or 5 half-lives since prior medication that directly inhibits platelet function

Performance status ECOG 0-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is comparing BMS-354825 to imatinib mesylate to see which is more effective in treating chronic phase chronic myelogenous leukemia.

Who is the study for?

This trial is for adults with chronic phase chronic myelogenous leukemia (CML) who didn't respond to imatinib mesylate. Participants must have specific blood and bone marrow conditions, not be eligible for stem cell transplantation, and can't have certain mutations or severe side effects from previous treatments.Check my eligibility

What is being tested?

The study compares BMS-354825 with imatinib mesylate in patients whose CML did not improve after prior treatment with imatinib. It aims to see which drug better stops cancer cells by blocking enzymes needed for their growth.See study design

What are the potential side effects?

Potential side effects include issues related to organ function, bleeding disorders, heart problems like arrhythmias or heart block, high blood pressure, and possibly other significant health complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

It's been over 5 days since I last took medication that affects blood clotting.

Select...

I am fully active or can carry out light work.

Select...

I do not have any serious uncontrolled illnesses or active infections.

Select...

I am not taking any drugs that strongly affect liver enzymes.

Select...

I can handle the side effects of the highest dose of imatinib I've previously taken.

Select...

I haven't had serious bleeding from my stomach or intestines in the last 6 months.

Select...

I haven't taken high-dose aspirin in the last 14 days.

Select...

I have been diagnosed with chronic phase CML.

Select...

I have never had a severe heart block.

Select...

I am 18 years old or older.

Select...

My organs are functioning normally without any significant health issues.

Select...

It has been over 14 days since my last cytarabine treatment.

Select...

My condition worsened despite being treated with imatinib.

Select...

I have never taken the drug BMS-354825.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Major cytogenic response (MCyR) rate at 12 weeks

Secondary outcome measures

Complete hematologic response rate

Duration of MCyR

MCyR at any time

+1 more

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

359 Previous Clinical Trials

26,075 Total Patients Enrolled

21 Trials studying Leukemia

221 Patients Enrolled for Leukemia

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,153 Total Patients Enrolled

1,512 Trials studying Leukemia

384,682 Patients Enrolled for Leukemia

Ronald Paquette, MDPrincipal InvestigatorJonsson Comprehensive Cancer Center

5 Previous Clinical Trials

102 Total Patients Enrolled

3 Trials studying Leukemia

16 Patients Enrolled for Leukemia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How secure is this therapy for individuals?

"This therapy has been evaluated to be moderately safe, receiving a score of 2. This is because the Phase 2 trial revealed some information regarding safety but lacked data concerning efficacy."

Answered by AI

Are there still openings available for this research endeavor?

"Concurrently with the current moment, this clinical trial is not calling for participants. Initially posted on March 1st 2005 and last updated June 4th 2011, 1455 other trials are currently searching for enrollees."

Answered by AI

Recent research and studies

BloodJournal

Dasatinib or High-dose Imatinib for Chronic-phase Chronic Myeloid Leukemia After Failure of First-line Imatinib: A Randomized Phase 2 Trial

Kantarjian, Hagop, Ricardo Pasquini, Nelson Hamerschlak, Philippe Rousselot, Jerzy Holowiecki, Saengsuree Jootar, Tadeusz Robak, et al.. 2007. “Dasatinib or High-dose Imatinib for Chronic-phase Chronic Myeloid Leukemia After Failure of First-line Imatinib: A Randomized Phase 2 Trial”. Blood. American Society of Hematology. doi:10.1182/blood-2006-11-056028.

CancerJournal

Dasatinib or High-dose Imatinib for Chronic-phase Chronic Myeloid Leukemia Resistant to Imatinib at a Dose of 400 to 600 Milligrams Daily

Kantarjian, Hagop, Ricardo Pasquini, Vincent Lévy, Saengsuree Jootar, Jerzy Holowiecki, Nelson Hamerschlak, Timothy Hughes, et al.. 2009. “Dasatinib or High-dose Imatinib for Chronic-phase Chronic Myeloid Leukemia Resistant to Imatinib at a Dose of 400 to 600 Milligrams Daily”. Cancer. Wiley. doi:10.1002/cncr.24504.

clinicaltrials.govStudy

BMS-354825 or Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Did Not Respond to Previous Imatinib Mesylate

2005. "BMS-354825 or Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Did Not Respond to Previous Imatinib Mesylate". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00112775.

All > Acute Myelogenous Leukemia > Gleevec