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Tyrosine Kinase Inhibitor

Imatinib or Dasatinib for Chronic Myeloid Leukemia

Phase 2

Waitlist Available

Led By Brian J Druker

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must have CML in chronic phase based on bone marrow aspiration and biopsy and peripheral blood counts obtained within 28 days before registration

Patients must have Zubrod performance status 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up patients were assessed for adverse events monthly every 4 weeks for the first year, every 6 months for years 2 and 3, and annually for years 4 and 5.

Awards & highlights

Study Summary

This trial looks at two different doses of imatinib mesylate and dasatinib to see how well they work in treating patients with previously untreated chronic phase chronic myelogenous leukemia.

Who is the study for?

This trial is for adults with newly diagnosed chronic phase chronic myelogenous leukemia who haven't had treatment except possibly hydroxyurea or anagrelide. They should be in good physical condition, not pregnant or breastfeeding, and willing to use birth control. Major surgery must not have been done recently, and they shouldn't have serious bleeding disorders or certain heart conditions.Check my eligibility

What is being tested?

The study compares the effectiveness of two drugs: Imatinib Mesylate at different doses and Dasatinib. These medications are designed to block enzymes that cancer cells need to grow. The trial randomly assigns patients to receive one of these treatments.See study design

What are the potential side effects?

Possible side effects include nausea, muscle cramps, rash, fluid retention (which can cause swelling around eyes or legs), diarrhea, fatigue, headache, joint pain; Dasatinib may also cause pleural effusion (fluid around lungs) and low blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My CML is in the chronic phase, confirmed by recent tests.

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I can take care of myself and am up and about more than 50% of my waking hours.

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My heart is healthy and I've had an ECG test in the last 42 days without major issues.

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I do not have a history of serious bleeding disorders not related to my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ patients were assessed for adverse events monthly every 4 weeks for the first year, every 6 months for years 2 and 3, and annually for years 4 and 5.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~patients were assessed for adverse events monthly every 4 weeks for the first year, every 6 months for years 2 and 3, and annually for years 4 and 5.

This trial's timeline: 3 weeks for screening, Varies for treatment, and patients were assessed for adverse events monthly every 4 weeks for the first year, every 6 months for years 2 and 3, and annually for years 4 and 5. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Molecular Response Rate at 12 Months

Secondary outcome measures

2-year Overall Survival (OS)

Hematologic Response

Toxicity

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm III (dasatinib)Experimental Treatment2 Interventions

Patients receive dasatinib PO BID. Treatment repeats every 4 weeks for up to 5 years in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (BID imatinib mesylate)Experimental Treatment2 Interventions

Patients receive imatinib mesylate PO BID. Treatment repeats every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.

Group III: Arm I (QD imatinib mesylate)Experimental Treatment2 Interventions

Patients receive imatinib mesylate PO QD. Treatment repeats every 4 weeks for up to 5 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Imatinib Mesylate

2003

Completed Phase 4

~800

Dasatinib

2012

Completed Phase 3

~2320

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,667 Previous Clinical Trials

40,925,760 Total Patients Enrolled

Brian J DrukerPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Dasatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00070499 — Phase 2

Chronic Myeloid Leukemia Research Study Groups: Arm II (BID imatinib mesylate), Arm I (QD imatinib mesylate), Arm III (dasatinib)

Chronic Myeloid Leukemia Clinical Trial 2023: Dasatinib Highlights & Side Effects. Trial Name: NCT00070499 — Phase 2

Dasatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00070499 — Phase 2

Frequently Asked Questions

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

What is Imatinib Mesylate employed for therapeutically?

"The drug Imatinib Mesylate has a variety of applications, including the treatment of newly diagnosed acute lymphoblastic leukaemia and refractory cases. It can also be used in certain scenarios to manage muscular dystrophy and metastatic dermatofibrosarcoma protuberans."

Answered by AI

Are there still openings available for participation in this research study?

"According to research hosted on clinicaltrials.gov, this trial is not actively accepting patients for participation at the current time. It was first posted on August 15th 2004 and last modified on August 30th 2022; however, there are still 1,558 other studies searching for volunteers right now."

Answered by AI

How many locations are conducting this research endeavor?

"To date, there are 100 clinical trial sites available for this study. A few examples of locations include Swedish Medical Center-First Hill in Pekin, OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center in Battle Creek and Bronson Battle Creek in Saint Louis."

Answered by AI

What earlier research has been conducted regarding Imatinib Mesylate?

"Currently, 103 trials are being conducted to analyse Imatinib Mesylate. Of those studies, 22 have reached Phase 3 of the scientific process. Moreover, while many of these tests originate in New york City, there are over 5000 locations worldwide running clinical investigations for this therapy."

Answered by AI

How many participants are currently included in the research study?

"This study is no longer taking in participants. It was uploaded on August 15th 2004 and had its last update on the 30th of August 2022. Currently, there are 1455 clinical trials searching for patients with leukemia, along with 103 studies for Imatinib Mesylate recruiting individuals."

Answered by AI

What adverse effects are associated with Imatinib Mesylate?

"Imatinib Mesylate has been proven to have a modicum of safety, so it receives a score of 2. Since this is only in Phase 2, there are no clinical data suggesting its efficacy yet."

Answered by AI

Recent research and studies

BloodJournal

A Randomized Trial of Dasatinib 100 Mg Versus Imatinib 400 Mg in Newly Diagnosed Chronic-phase Chronic Myeloid Leukemia

Radich, Jerald P., Kenneth J. Kopecky, Frederick R. Appelbaum, Suzanne Kamel-Reid, Wendy Stock, Greg Malnassy, Elisabeth Paietta, et al.. 2012. “A Randomized Trial of Dasatinib 100 Mg Versus Imatinib 400 Mg in Newly Diagnosed Chronic-phase Chronic Myeloid Leukemia”. Blood. American Society of Hematology. doi:10.1182/blood-2012-02-410688.

clinicaltrials.govStudy

Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia

2004. "Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00070499.

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