New cocktail of cancer drugs tested for tough leukemia
NCT ID NCT01861314
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This early-phase trial tests a combination of three drugs — bortezomib, sorafenib, and decitabine — in patients with acute myeloid leukemia (AML), especially those who are older or have hard-to-treat forms. The main goal is to find the safest dose and see how well patients tolerate the combination. Researchers will also look for early signs that the drugs are working against the leukemia.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bortezomib, sorafenib tosylate, and decitabine
- What this could lead to
- If this works, it could point toward a new treatment option for older or hard-to-treat AML patients who cannot have standard chemotherapy.
- What could go wrong
- This is a very early phase 1 trial with only 15 participants, focused on safety and dosing — not yet testing if the combination truly works. Side effects from the three drugs may be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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15 people
The number who actually took part.
- Started
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Jul 2013
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have histologically or cytologically confirmed acute myeloid leukemia (AML) by World Health Organization (WHO) criteria in the blood and/or marrow AND age \>= 60 and not candidates/refuse standard induction treatment OR who have one of the following: poor risk cytogenetics, AML following antecedent hematologic disorder, or therapy-related AML * Patients with relapsed or refractory AML age \>= 18 years are also eligible for treatment; patients may have been treated for antecedent hematologic disorder with myeloid growth factors, recombinant erythropoietin, thalidomide, lenalidomide, 5-azacitidine or the 5 day schedule of decitabine; patients who have received the 10 day schedule of decitabine for treatment an antecedent hematologic disorder or AML are not eligible * If the patient has co-morbid medical illness, life expectancy attributed to this must be greater than 6 months * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Total bilirubin \< 2.0 mg/dL * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transferase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transferase \[SGPT\]) \< 2.5 X institutional upper limit of normal * Creatinine \< 2.0 mg/dL or creatinine clearance (CrCl) \>= 60 mL/min * Prothrombin time (PT)/international normalized ratio (INR) monitoring, \< 1.5 x institutional upper limits of normal * Both women and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; if the patient does not agree, the patient is not eligible * Ability to understand and willingness to sign the written informed consent document Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study; hydroxyurea may be administered for count control both pre-treatment and during cycle 1 only * Patients receiving any other investigational agents or patients that have received other investigational agents within 14 days of enrollment * Patients with active central nervous system disease or with granulocytic sarcoma as sole site of disease * Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib, bortezomib or decitabine that are not easily managed * Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; as infection is a common feature of AML, patients with active infection are permitted to enroll provided that the infection is under control; myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, uncontrolled hypertension, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities * Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study * Patients with pre-existing grade 2 or higher neuropathy or other serious neurologic toxicity that would significantly increase risk of complications from bortezomib therapy are excluded * Patients with a known confirmed diagnosis of human immunodeficiency virus (HIV) infection who are taking chronic anti-retroviral therapy (HAART) are ineligible if there is a potential for drug-drug interactions with the chemotherapeutic agents; patients with a known confirmed diagnosis of HIV infection who meet standard eligibility criteria and are not taking HAART with a potential for drug-drug interactions are eligible * Patients with advanced malignant solid tumors are excluded * Patients with known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of sorafenib * Patients who are taking concomitant medications that in the investigator's opinion are strong inducers of the cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) enzymes and therefore likely to interact with the study agents, will not be eligible
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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