Belinostat and Azacitidine in Treating Patients With Advanced Hematologic Cancers or Other Diseases (NCT00351975) | Clinical Trial Compass
CompletedPhase 1
Belinostat and Azacitidine in Treating Patients With Advanced Hematologic Cancers or Other Diseases
United States, Canada, New Zealand56 participantsStarted 2006-06
Plain-language summary
This phase I trial is studying the side effects and best dose of belinostat when given together with azacitidine in treating patients with advanced hematologic cancers or other diseases. Belinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving belinostat together with azacitidine may kill more cancer cells.
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:
* Histologically confirmed diagnosis of 1 of the following:
* Relapsed or refractory acute myeloid leukemia (AML)
* Relapsed or refractory acute promyelocytic leukemia (must have failed both tretinoin and arsenic trioxide)
* Relapsed or refractory acute lymphoblastic leukemia
* Secondary AML, including AML arising from antecedent hematologic diseases, such as myelodysplastic syndromes (MDS) or myeloproliferative disorders, OR therapy-related AML
* Chronic myelogenous leukemia in accelerated or blast phase
* Advanced phases of Philadelphia chromosome-negative (Ph-) chronic myeloproliferative disorders, as defined by ≥ 1 of the following:
* Presence of anemia (hemoglobin \< 10 g/dL and/or red blood cell transfusion dependent)
* Presence of palpable splenomegaly
* MDS, including chronic myelomonocytic leukemia
* Must have intermediate or high-risk International Prognostic Scoring System (IPSS) scores (≥ 0.5)
* Low-risk IPSS scores allowed provided ≥ 1 of the following criteria are met:
* Hemoglobin \< 10 g/dL and/or red blood cell transfusion dependent
* Platelet count \< 50,000/mm³
* Absolute neutrophil count \< 1,000/mm³
* Refractory disease OR no standard therapy exists
* Evidence of AML associated with dysplasia on bone marrow histology for elderly patients (i.e., \> 60 years old) who are previously untreated and not candidates for or unwilling to undergoing induction therapy
* No known active CNS invol…
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
Maximum tolerated dose of belinostat in combination with azacitidine