Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Accelerated Phase or Blastic Pha… (NCT00081133) | Clinical Trial Compass
CompletedPhase 1/2
Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Accelerated Phase or Blastic Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
United StatesStarted 2003-12
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Combining arsenic trioxide with imatinib mesylate may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of arsenic trioxide when given with imatinib mesylate and to see how well they work in treating patients with accelerated phase or blastic phase chronic myelogenous leukemia or Philadelphia chromosome-positive 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.
DISEASE CHARACTERISTICS:
* Diagnosis of one of the following:
* Chronic myelogenous leukemia (CML) in one of the following phases:
* Blastic phase\*
* Accelerated phase\*
* No appropriate donors for stem cell transplantation NOTE: \*Must have received high-dose (600-800 mg/day) imatinib mesylate of no more than 3 months duration
* Acute lymphoblastic leukemia
* Philadelphia chromosome positive by cytogenetic confirmation
* Patients with only bcr-abl-positive disease by polymerase chain reaction are not eligible
* \> 10% blasts in the bone marrow
* No isolated extramedullary disease
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* AST ≤ 2 times ULN
* INR and PTT ≤ 1.5 times ULN (except for patients on anticoagulation therapy)
Renal
* Creatinine ≤ 2 times ULN
Cardiovascular
* Baseline QTc intervals \< 480 ms
* No chronic arrhythmias
* No active coronary artery disease
Other
* No chronic electrolyte abnormalities
* No prior non-compliance to medical regimens
* No patients who are considered potentially unreliable
* No active serious infection
* No other active malignancies except superficial epithelial cancers
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for at least 3 months after study participation
PR…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.