Entinostat and Clofarabine in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Poo… (NCT01132573) | Clinical Trial Compass
CompletedPhase 1
Entinostat and Clofarabine in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Poor-Risk Acute Lymphoblastic Leukemia or Bilineage/Biphenotypic Leukemia
United States27 participantsStarted 2010-04
Plain-language summary
This phase I trial studies the side effects and best dose of entinostat when given together with clofarabine in treating patients with newly diagnosed, relapsed, or refractory poor-risk acute lymphoblastic leukemia or bilineage/biphenotypic leukemia. Entinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving entinostat with clofarabine may kill more cancer cells.
Who can participate
Age range
21 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:
* Adults age \>= 40 years with the established, pathologically-confirmed diagnoses of newly diagnosed ALL or ABL are eligible for study; adults with relapsed and refractory ALL or ABL who are \>= 21 years of age and who have progressive disease following their last therapy are eligible for study; the additional following criteria must be met:
* For adults with relapsed/refractory ALL, no more than 5 previous regimens
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
* Patients must be able to give informed consent
* Female patients of childbearing age must have negative pregnancy test
* Total white blood cell count (WBC) =\< 150,000 with no evidence for ongoing or impending leukostasis
* Total bilirubin =\< 2.0 mg/dL unless elevated due to Gilbert's disease, hemolysis or leukemic infiltration
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 × upper limit of normal (ULN) unless due to leukemic infiltration
* Serum creatinine =\< 2.0 mg/dL
* Left ventricular ejection fraction (LVEF) \>= 45% as measured by echocardiogram (ECHO) or multi gated acquisition (MUGA) scan
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 30 days after study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediatel…
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.
What they're measuring
1
Frequency of the observed toxicities based on the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Timeframe: Up to 360 days
2
MTD of entinostat followed by clofarabine, defined as the dose at which less than 2 of 3 patients experience dose limiting toxicity graded according to NCI CTCAE version 4.0