Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblasti… (NCT01424982) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia
United States88 participantsStarted 2011-10-05
Plain-language summary
This phase II trial studies the side effects and how well combination chemotherapy and ponatinib hydrochloride work in treating patients with acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ponatinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy and ponatinib hydrochloride may be an effective treatment for acute lymphoblastic leukemia.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of one of the following:
* Previously untreated Ph-positive ALL \[either t(9;22) and/or bcr-abl positive\] (includes patients initiated on first course of hyper-CVAD before cytogenetics known) or with lymphoid accelerated or blast phase chronic myelogenous leukemia (CML)
* Previously treated Ph-positive ALL or CML (in accelerated phase or blast phase), after 1-2 courses of chemotherapy with or without other tyrosine kinase inhibitors (TKIs)
* If they achieved complete response (CR), they are assessable only for event-free and overall survival, or
* If they failed to achieve CR, they are assessable for CR, event-free, and overall survival
* Performance status ≤ 2 (Eastern Cooperative Oncology Group \[ECOG\] scale, Appendix E)
* Adequate liver function as defined by the following criteria:
* Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome
* Alanine aminotransferase (ALT) ≤ 2 x ULN
* Aspartate aminotransferase (AST) ≤ 2.5 x ULN
* Adequate pancreatic function as defined by the following criteria:
* Serum lipase and amylase ≤ 1.5 x ULN
* For females of childbearing potential, a negative pregnancy test must be documented prior to randomization
* Female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from randomization through 4 months after the end of treatment
* Adequate cardiac function as assessed clinically by history and p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines ponatinib with chemotherapy specifically for Philadelphia chromosome-positive ALL — does my leukemia have the BCR-ABL1 mutation that this trial is targeting, and is that something my test results have confirmed?
2Since this is a Phase 2 trial, what do we know so far about the safety profile of combining ponatinib with chemotherapy, and are there any serious risks I should be aware of before considering this approach?
3The trial is measuring 'event-free survival' as its main goal — can you help me understand what counts as an 'event' in this context, and what the results so far suggest about how well this combination is working?
4The trial is no longer actively enrolling — does that mean participation might still be possible in some circumstances, or would you recommend we focus on other current trials or standard treatments instead?
5Ponatinib is a targeted therapy that was originally developed for CML — how does its use alongside standard ALL chemotherapy compare to other BCR-ABL1-targeted approaches, like dasatinib-based regimens, that I might also be a candidate for?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Event-free survival
Timeframe: The time from the start of the treatment until any failure (resistant disease, relapse, or death), assessed up to 24 months