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This study looks at using Belinostat together with Azacitidine in patients with advanced blood (hematologic) cancers or other diseases. Patients with relapsed or treatment-resistant blood disorders such as acute myeloid leukemia or myelodysplastic syndromes were able to take part. Sponsored by the National Cancer Institute (NCI), the study was conducted in Phase 1 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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 involvement with disease
* CALGB performance status (PS) 0-2 OR Karnofsky PS 60-100%
* Bilirubin ≤ 2.0 mg/dL (unless due to Gilbert's syndrome)
* ALT ≤ 3 times upper limit of normal (unless due to disease)
* Creatinine ≤ 2 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101 or Azacitidine
* No history of allergic reactions to mannitol
* No history of dose-limiting toxicity during prior treatment with Azacitidine
* No concurrent uncontrolled illness including, but not limited to, the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness or social situation that would preclude compliance with study requirements
* No marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \> 500 msec)
* No long QT syndrome
* No uncontrolled cardiovascular disease, including the following:
* Severe uncontrolled hypertension
* Uncontrolled congestive heart failure related to primary cardiac disease
* Uncontrolled cardiac arrhythmia
* Uncontrolled ischemic or severe valvular heart disease
* Myocardial infarction within the past 6 months
* See Disease Characteristics
* Recovered from prior therapy
* At least 2 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)
* At least 2 weeks since prior radiotherapy
* At least 4 weeks since prior investigational agents
* At least 24 hours since prior hydroxyurea
* At least 2 weeks since prior valproic acid
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational agents
* No concurrent medication that may cause torsade de pointes
* No other concurrent anticancer therapy, including chemotherapy, radiotherapy, or biological agents