← Back to Search

Tyrosine Kinase Inhibitor

Dasatinib for Pediatric Leukemia

Phase 2

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

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

Must have

Newly diagnosed, treatment naive CP-CML (Cohort 3)

CP-CML who prove resistant or intolerant to imatinib (Cohort 1)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of dasatinib in children and adolescents with leukemia who either have not responded to or cannot tolerate imatinib.

Who is the study for?

This trial is for children and adolescents with newly diagnosed chronic myeloid leukemia (CML) or Ph+ acute lymphoblastic leukemia (ALL) who are resistant or intolerant to imatinib. Participants must have a life expectancy of at least 12 weeks, good liver and kidney function, and provide written consent. They should not have symptomatic CNS involvement, prior dasatinib therapy, or be on certain other medications.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of dasatinib in young patients with various phases of CML or ALL who can't use imatinib. It includes three cohorts: those new to treatment, those resistant/intolerant to imatinib, and a pharmacokinetics substudy group analyzing drug levels in the body.See study design

What are the potential side effects?

Possible side effects of dasatinib include immune system suppression leading to increased infection risk; digestive issues like nausea; potential liver toxicity; headaches; skin rashes; fluid retention around eyes or lungs; muscle pain.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have just been diagnosed with chronic myeloid leukemia and haven't started treatment.

Select...

I have CML and cannot tolerate or didn't respond to imatinib.

Select...

I can do most activities but need help with some.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Complete Cytogenetic Response (CCyR) Rate

Complete Hematologic Response (CHR) Rate

Major Cytogenetic Response (MCyR) Rate

Secondary outcome measures

Complete Cytogenetic Response (CCyR) Rate up to 2 Years

Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3

Complete Molecular Response (CMR) Rate

+15 more

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT03023046

26%

Febrile neutropenia

17%

Sepsis

Mucositis oral

Upper gastrointestinal hemorrhage

Intracranial hemorrhage

Hypotension

Hypertension

Enterocolitis

Lower gastrointestinal hemorrhage

Delirium

Oropharyngeal pain

Gastric hemorrhage

Abdominal pain

Diarrhea

Fungemia

Typhlitis

Myocardial infarction

Fibrinogen decreased

Endophthalmitis

Multi-organ failure

Kidney infection

Peripheral motor neuropathy

Hypoxia

Sinus bradycardia

Edema limbs

Small intestinal obstruction

Atrial fibrillation

Aspiration

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Chemotherapy)

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3: Newly diagnosed, treatment naïve CP-CMLExperimental Treatment1 Intervention

Dasatinib 60 mg/m² tablet QD [with a maximum dose of 100 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 72 mg/m² PFOS QD [with a maximum dose of 120 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit

Group II: Cohort 2: Ph+ALL or AP- or BP-CMLExperimental Treatment1 Intervention

Dasatinib 80 mg/m² tablet QD [with a maximum dose of 140 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 96 mg/m² PFOS QD [with a maximum dose of 170 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit

Group III: Cohort 1: Imatinib-resistant/intolerant CP-CMLExperimental Treatment1 Intervention

Dasatinib 60 mg/m² tablet every day (QD) [with a maximum dose of 100 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 72 mg/m² powder for oral suspension (PFOS) QD [with a maximum dose of 120 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dasatinib

2012

Completed Phase 3

~2320

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,128,384 Total Patients Enrolled

81 Trials studying Leukemia

13,885 Patients Enrolled for Leukemia

Media Library

Dasatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00777036 — Phase 2

Leukemia Research Study Groups: Cohort 2: Ph+ALL or AP- or BP-CML, Cohort 3: Newly diagnosed, treatment naïve CP-CML, Cohort 1: Imatinib-resistant/intolerant CP-CML

Leukemia Clinical Trial 2023: Dasatinib Highlights & Side Effects. Trial Name: NCT00777036 — Phase 2

Dasatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00777036 — Phase 2

Frequently Asked Questions

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

Does this experiment only test on subjects who are older than 45?

"Children as young as one day old may participate in this trial, provided they meet the other requirements listed in the inclusion criteria. There are 460 clinical trials currently seeking participants who are under 18 years old and 1259 studies recruiting people that are over 65."

Answered by AI

How many different locations are conducting this trial?

"Currently, 47 clinical trial locations are active and recruiting patients. These include Local Institution - 0004 in Atlanta, Children's Healthcare of Atlanta - Egleston Hospital in New york, Local Institution - 0061 in Toronto, as well as 44 other sites."

Answered by AI

How many willing test subjects are required for this clinical trial?

"This particular trial is no longer enrolling patients. It was initially posted on March 20th, 2009 and last updated on November 7th, 2022. However, if you are interested in participating in other trials, there are currently 1507 trials related to leukemia and 66 for Dasatinib that are actively recruiting participants."

Answered by AI

What else is known about Dasatinib from academic research?

"Dasatinib was first investigated in 2004 by researchers at Swedish Medical Center-First Hill. 138 clinical trials have been completed thus far, with the most recent ones being conducted in Atlanta, Georgia."

Answered by AI

Has the FDA cleared Dasatinib for public use?

"Dasatinib safety was given a score of 2 by our analysts at Power. This is because, while there is some evidence suggesting the medication is safe, there is no data attesting to its efficacy."

Answered by AI

What are the goals of this experiment?

"The purpose of this study is to track Major Cytogenetic Response (MCyR) Rate over the course of treatment and follow up. Additionally, researchers will be paying attention to Time to MCyR, Complete Cytogenetic Response (CCyR) Rate, and Complete Hematologic Response (CHR) rate in order to better understand the efficacy of the medication."

Answered by AI

Who would be a good candidate to sign up for this research project?

"This trial is looking for 130 participants aged 1 day to 18 years old who have leukemia. In addition to meeting the general age and health criteria, potential patients must also match the following specific profile: -Target Population for the PK substudy subjects must have CP-CML and be taking daily dasatinib (tablets or PFOS) either as part of Cohort 1 or Cohort 3 of this protocol. Patients receiving commercial dasasinib tablets outside of this protocol may be invited to participate in this PK substudy, -Target Population for the PK substudy must obtain written informed"

Answered by AI

Are they looking for more test subjects at this time?

"The study you are inquiring about is not enrolling new patients at this time, as reflected on clinicaltrials.gov. This research was first posted on March 20th, 2009 and last updated on November 7th, 2020. There are 1573 other trials that may be of interest to you which are actively recruiting right now."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Dasatinib in Pediatric Patients with Chronic Myeloid Leukemia in Chronic Phase: Results from a Phase II Trial

Gore, Lia, Pamela R. Kearns, Maria Lucia de Martino, Lee, Carmino Antonio De Souza, Yves Bertrand, Nobuko Hijiya, et al.. 2018. “Dasatinib in Pediatric Patients with Chronic Myeloid Leukemia in Chronic Phase: Results from a Phase II Trial”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2017.75.9597.

clinicaltrials.govStudy

A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib

2009. "A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00777036.

All > Acute Myeloid Leukemia > Dasatinib