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Chemotherapy Agent
Chemotherapy + TKI for Acute Lymphoblastic Leukemia
Phase 2
Waitlist Available
Led By Patrick Burke, MD
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients ≥ 18 years of age
Baseline ECOG Performance Status ≤ 2, and patient is a candidate for intensive chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after last treatment, up to approximately 3 years
Awards & highlights
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.
Who is the study for?
Adults with newly diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) who are at least 18 years old, have a performance status allowing for intensive chemotherapy, and can provide informed consent. Excluded are those with certain other leukemia types, significant liver or heart conditions, active infections like HIV or hepatitis B/C, uncontrolled bleeding disorders, and women who are pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial tests pediatric-inspired chemotherapy combined with tyrosine kinase inhibitors Dasatinib or Ponatinib in adults with Ph+ ALL. There are two age groups: 18-59 and 60+. The TKI used depends on the chemo cycle to minimize side effects. Dosages of both chemo agents and TKIs are adjusted by age group for continuous administration.See study design
What are the potential side effects?
Potential side effects include immune system suppression leading to increased infection risk; nausea; mouth sores; hair loss from chemotherapy; plus possible fluid retention, muscle pain, rash from TKIs. Heart rhythm problems could occur due to underlying conditions exacerbated by treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can care for myself and am eligible for strong chemotherapy.
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My cancer is positive for the Philadelphia chromosome.
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I haven't been treated for my condition, except possibly with corticosteroids, hydroxyurea, or leukapheresis just after diagnosis.
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I have been recently diagnosed with Ph+ acute lymphoblastic leukemia.
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My cancer is of B-Cell origin according to tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days after last treatment, up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after last treatment, up to approximately 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of complete molecular remission (CMR) at the end of one cycle of Dasatinib + BFM
Secondary outcome measures
Complete cytogenic remission (CCyR) rate post induction
Complete hematologic (morphologic) remission (CHR) rate after induction
Complete molecular remission (CMR) rate
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: BFM + Tyrosine Kinase InhibitorExperimental Treatment4 Interventions
This study has 2 cohorts: participants aged 18 - 59 years and participants aged 60 or more years. Both cohorts receive the same study intervention with dosage adjusted for age. Participants receive the Berlin-Frankfurt-Münster (BFM) protocol plus dasatinib during a two-phase induction and a delayed re-induction. Participants receive the BFM protocol plus ponatinib during post-induction consolidations and maintenance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib
2012
Completed Phase 3
~2320
Ponatinib
2015
Completed Phase 2
~820
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
293 Previous Clinical Trials
24,097 Total Patients Enrolled
TakedaIndustry Sponsor
1,202 Previous Clinical Trials
4,178,262 Total Patients Enrolled
Patrick Burke, MDPrincipal InvestigatorUniversity of Michigan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken strong CYP3A4 affecting drugs or supplements recently.I do not have serious heart problems, uncontrolled high blood pressure, severe pancreas issues, or ongoing severe nausea.I have a history of HIV, Hepatitis B, or Hepatitis C.My leukemia is B-Cell ALL and does not have the Philadelphia chromosome.My leukemia is T-cell based.My leukemia has returned after treatment.My leukemia is identified as Mature B-Cell (Burkitt's).I am 18 years old or older.My kidney function is low, but it's due to my cancer or treatment and can be treated.I can care for myself and am eligible for strong chemotherapy.My cancer is positive for the Philadelphia chromosome.My heart's pumping ability is confirmed to be less than 45%.I agree to use effective birth control during and up to 30 days after the trial.My condition is a severe phase of chronic myeloid leukemia.My leukemia has spread to my brain or testes.I do not have a history of serious bleeding disorders.I haven't needed treatment for any cancer other than ALL in the last 2 years, except for certain skin cancers or early-stage cancers.I haven't been treated for my condition, except possibly with corticosteroids, hydroxyurea, or leukapheresis just after diagnosis.I have been recently diagnosed with Ph+ acute lymphoblastic leukemia.My cancer is of B-Cell origin according to tests.I show symptoms of a brain or spinal cord condition.
Research Study Groups:
This trial has the following groups:- Group 1: BFM + Tyrosine Kinase Inhibitor
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA issued a stamp of approval for Dasatinib?
"As it is a Phase 2 trial, there are data points demonstrating its safety but not yet proving efficacy; for this reason, Dasatinib was given a score of 2."
Answered by AI
How many participants are actively enrolled in this study?
"Affirmative. Clinicaltrials.gov verifies that this clinical trial, which was first published on October 1st 2022, is actively looking for subjects. 23 individuals need to be signed up from one medical centre."
Answered by AI
Is enrollment for this medical experiment currently available?
"Affirmative. According to the records on clinicaltrials.gov, this medical trial is in search of 23 volunteers from a single site location since it was initially posted on October 1st 2022 and edited most recently on August 31st 2022."
Answered by AI
What is the customary application of Dasatinib?
"Dasatinib is mainly used to combat small cell lung cancer, but also have success in treating active pauciarticular juvenile rheumatoid arthritis, multiple sclerosis, and head and neck carcinoma."
Answered by AI
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