Study Summary
This trial will study the safety and efficacy of a combination of standard chemotherapy and tyrosine kinase inhibitors (TKIs) in adults with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.
Eligible Conditions
- Acute Lymphoblastic Leukemia
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: 30 days after last treatment, up to approximately 3 years
Year 3
Rate of Adverse Events related to Dasatinib and Ponatinib
Year 3
Complete cytogenic remission (CCyR) rate post induction
Complete hematologic (morphologic) remission (CHR) rate after induction
Complete molecular remission (CMR) rate
At 18 weeks
Percentage of participants who begin ponatinib post-induction that complete at least one cycle.
Day 43
Rate of complete molecular remission (CMR) at the end of one cycle of Dasatinib + BFM
Year 8
Disease-free survival (DFS)
Overall survival (OS).
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
1 Treatment Group
BFM + Tyrosine Kinase Inhibitor
1 of 1
Experimental Treatment
23 Total Participants · 1 Treatment Group
Primary Treatment: Dasatinib · No Placebo Group · Phase 2
BFM + Tyrosine Kinase InhibitorExperimental Group · 4 Interventions: Methotrexate and Cytarabine, Berlin-Frankfurt-Münster Chemotherapy, Dasatinib, Ponatinib · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib
FDA approved
Ponatinib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days after last treatment, up to approximately 3 years
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
267 Previous Clinical Trials
18,085 Total Patients Enrolled
TakedaIndustry Sponsor
1,119 Previous Clinical Trials
4,054,310 Total Patients Enrolled
Patrick Burke, MDPrincipal InvestigatorUniversity of Michigan
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:There is a newly diagnosed form of leukemia known as Ph+ ALL.
I agree to allow the medical staff to screen me for my illness prior to providing written consent
A form of leukemia characterized by an abnormal chromosome called the Philadelphia chromosome.
Patients who are at least 18 years old.
The patient has a good Baseline ECOG Performance Status, and is a candidate for intensive chemotherapy.
The patient is able to understand the risks and benefits of the surgery and give informed consent.
Analysis of cell surface markers can be used to determine the cell lineage of a particular cell
Ph+ leukemia is a type of leukemia that is caused by a change in the chromosomes (karyotype) or by a change in the genes (molecular).
The text is saying that the determination was made in a laboratory that is certified by the Clinical Laboratory Improvement Amendments (CLIA).
The key inclusion criteria are a patient’s age, diagnosis, and length of stay
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments