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Tyrosine Kinase Inhibitor

Dasatinib for Chronic Myeloid Leukemia

Phase 2
Waitlist Available
Led By Lucia Masarova
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance of 0-2
Adequate end organ function: total bilirubin <1.5 x ULN, SGPT <2.5x ULN, creatinine <1.5x ULN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial studies dasatinib for early chronic phase chronic myelogenous leukemia. Dasatinib may stop cancer cell growth by blocking enzymes needed for cell growth.

Who is the study for?
This trial is for patients aged 16 or older with early chronic phase Chronic Myelogenous Leukemia (CML), diagnosed within the last 12 months, who have had minimal prior treatment. They should be in good physical condition (ECOG performance of 0-2) and have normal organ function. Pregnant or breastfeeding women are excluded, as well as those with serious heart disease, uncontrolled psychiatric disorders, significant bleeding disorders, or a history of arrhythmias.Check my eligibility
What is being tested?
The study is testing Dasatinib's effectiveness in treating early chronic phase CML by blocking enzymes that cancer cells need to grow. It includes quality-of-life assessments and laboratory biomarker analysis to understand how well it works and its impact on patients' lives.See study design
What are the potential side effects?
While not specified here, common side effects of Dasatinib may include fluid retention issues like swelling around the eyes or in the lungs, low blood cell counts which can increase infection risk or cause fatigue/bleeding problems, nausea, diarrhea, muscle pain and skin rashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself and perform daily activities.
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My liver and kidney functions are within normal limits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Probability of major molecular response
Toxicity rate
Other outcome measures
Quality of life during dasatinib therapy
Symptom burden during dasatinib therapy (optional)
Symptom severity during dasatinib therapy
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (twice daily dasatinib)Experimental Treatment5 Interventions
Patients receive dasatinib PO BID for up to 15-18 years.
Group II: Arm A (once daily dasatinib)Experimental Treatment5 Interventions
Patients receive dasatinib PO QD for up to 15-18 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib
2012
Completed Phase 3
~2320

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,490 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,293 Total Patients Enrolled
Lucia MasarovaPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials

Media Library

Dasatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00254423 — Phase 2
Chronic Myelogenous Leukemia Research Study Groups: Arm B (twice daily dasatinib), Arm A (once daily dasatinib)
Chronic Myelogenous Leukemia Clinical Trial 2023: Dasatinib Highlights & Side Effects. Trial Name: NCT00254423 — Phase 2
Dasatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00254423 — 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 the maximum capacity of enrollees for this experiment?

"Presently, this study is not seeking any more participants. It was initially registered on November 8th 2005 and updated most recently on May 31st 2022. If you are looking for alternative trials, there are currently 1455 studies actively recruiting patients diagnosed with leukemia, myeloid chronic-phase and 64 Pharmacological Studies that require volunteers."

Answered by AI

Has the Pharmacological Study been sanctioned by the Federal Drug Administration?

"In consideration of the Phase 2 status, our team at Power assigned a safety rating of 2 to this pharmacological study. This is due to existing evidence for its security but not yet any proof that it produces desirable outcomes."

Answered by AI

Have any other investigations sought to explore the efficacy of this Pharmacological Study?

"Presently, 64 clinical trials are researching treatments related to Pharmacological Study. Of those active investigations, 9 have advanced to Phase 3 of the research process. Although most studies on this treatment occur in New york City, there are 4258 sites conducting these experiments worldwide."

Answered by AI

Is this investigation actively seeking participants?

"Per the clinicaltrials.gov listing, this research project is not currently accepting new participants. The trial began on November 8th 2005 and was last modified May 31st 2022. However, there are 1519 other studies still open to enrollment at this moment in time."

Answered by AI
Recent research and studies
~5 spots leftby Nov 2024