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Chemotherapy + Ponatinib + Blinatumomab for Acute Lymphoblastic Leukemia
Study Summary
This trial is testing low-intensity chemotherapy with ponatinib and blinatumomab for patients with Philadelphia chromosome-positive and/or BCR-ABL positive acute lymphoblastic leukemia that may have come back or is not responding to treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 2 trial • 171 Patients • NCT01935336Trial Design
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Who is running the clinical trial?
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- I am 18 or older with a specific type of leukemia (Ph-positive ALL) that hasn't been treated yet.I am 18 or older with a specific type of leukemia that has not responded to treatment.I am not pregnant or breastfeeding and, if capable of becoming pregnant, will use birth control.I have a serious infection that isn't getting better with antibiotics.I have active hepatitis B but am on treatment to control it.I have had pancreatitis within the last year or suffer from chronic pancreatitis.My heart is healthy based on recent exams.I have a significant brain condition, but not active CNS leukemia.I have or had an autoimmune disease that could affect my brain or spinal cord.I have a bleeding disorder not related to my cancer.I have fluid buildup in my chest or heart area not caused by my leukemia.I do not have another cancer that is expected to shorten my life to under a year.I do not have severe heart failure.I haven't taken strong CYP3A4 inhibitors recently.I can do most of my daily activities on my own.I am a woman who is either postmenopausal, surgically sterile, using two forms of birth control, or not having sex.I am a male willing to use contraception or abstain from sex during and 4 months after the study.I do not have active or uncontrolled heart or blood vessel problems.I have very high triglyceride levels that aren't managed.
- Group 1: Treatment (chemotherapy, ponatinib, blinatumomab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What research has been accomplished using Ponatinib to date?
"At the moment, Ponatinib is being tested in 1466 trials. Of these studies, 304 are currently in Phase 3 and 45749 are located across a variety of sites with the majority found near Bethesda, Maryland."
Has Ponatinib been granted a seal of approval by the FDA?
"Due to the fact that Ponatinib is currently undergoing Phase 2 trials, demonstrating safety but not yet efficacy, it has been assigned a score of two."
What condition is Ponatinib most typically prescribed to treat?
"Ponatinib is regularly used to treat transplanted livers, but it has also been proven successful in providing relief from lung cancers, small cell lung cancer (SCLC), and multiple sclerosis."
To what extent is the current research being conducted on a sample population?
"Affirmative. Clinicaltrials.gov has data which verifies that this medical investigation is actively seeking volunteers, with its initial posting date of February 8th 2018 and the last update on October 31st 2022. 60 participants are required to be enrolled at a single location."
What aims does this clinical trial seek to accomplish?
"The primary goal of this 84 day trial is to measure the overall response rate in participants with relapsed/refractory acute lymphoblastic leukemia. Secondary assessments include complete cytogenetic response, incidence of adverse events (graded according to NCI CTCAE v4.0), and event-free survival probabilities as estimated by Kaplan-Meier methodology."
Are there any opportunities for enrollment in this experiment at present?
"clinicialtrials.gov has confirmed that this scientific investigation is still open to participants, with the study first posted on February 8th 2018 and last edited October 31st 2022."
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