Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Ability to understand and the willingness to sign a written informed consent document.
- - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- - Participants eligible for this study have either MPN in accelerated phase (AP) or blast phase (BP), defined as: - MPN-AP is defined by 10% to 19% blasts in the peripheral blood or bone marrow.
- - MPN-BP is defined by >= 20% blasts in the blood or bone marrow.
- - Either MPN-AP or MPN-BP requires a previous diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), or primary myelofibrosis (PMF) - Participants with ET, PV, or MF that have received prior MPN-associated therapy (e.g., hydroxyurea, hypomethylating agents [azacitidine, decitabine], anti-platelet therapies [e.g., aspirin, anagrelide], as well as JAK2 inhibitor therapy [e.g., ruxolitinib or other investigational JAK2 inhibitor]) are eligible.
- - Female participants of childbearing potential must agree to use adequate contraception (2 forms of contraception or abstinence) from the screening visit until 30 days following the last dose of study treatment.
- - Male participants of childbearing potential having intercourse with females of childbearing potential must agree to abstain from heterosexual intercourse or have their partner use 2 forms of contraception from the screening visit until 90 days until the last dose of study treatment.
- - Left ventricular ejection fraction at >= 50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan (14 days prior to initiating study treatment) - Candidate for cytotoxic-intensive induction chemotherapy.
- - Willing to take oral medication.
- - Serum creatinine =< 2 x the upper limit of normal (ULN), or glomerular filtration rate > 20 ml/min/1.73m^2 as calculated by Cockcroft-Gault formula.
- - Serum potassium, magnesium, and calcium (corrected for albumin) within institutional normal limits or can be corrected with supplementation.
- - Total serum bilirubin =< 2.5 x ULN.
- - Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) =< 2.5 x ULN.
- - Ongoing participation in another clinical trial.
- - Isolated myeloid sarcoma (i.e., participants must have blood or marrow involvement with AML to enter the study) - Acute promyelocytic leukemia (French-American-British [FAB] M3 classification) - Active central nervous system (CNS) involvement by AML.
- - Current treatment or treatment within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of study medication with another investigational medication or current enrollment in another investigational drug protocol (unless there is evidence of rapidly progressive disease in which case a shorter interval from last therapy may be acceptable) - Any unresolved toxicity equal to or greater than grade 2 from previous anticancer therapy, except for stable chronic toxicities not expected to resolve, such as peripheral neurotoxicity.
- - Incomplete recovery from any prior surgical procedures or had surgery within 4 weeks prior to study entry, excluding the placement of vascular access.
- - Disseminated intravascular coagulopathy with active bleeding or signs of thrombosis.
- - Participants with rapidly progressive disease (defined by blast count doubling within 48 hours) or organ dysfunction that would prevent them from receiving these agents.
- - Participants with uncontrolled infection will not be enrolled until infection is treated and symptoms controlled.
- - Participants with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for >= 72 hours (hrs) - Known hypersensitivity to ruxolitinib, cytarabine, daunorubicin, or liposomal products.
- - History of Wilson's disease or other copper metabolism disorder.
- - Uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the protocol per investigator's discretion.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Ohio State University Comprehensive Cancer Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Uma Borate, MD|
|Principal Investigator Affiliation||The Ohio State Comprehensive Cancer Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Essential Thrombocythemia, Myelofibrosis, Myeloproliferative Neoplasm, Polycythemia Vera, Secondary Acute Myeloid Leukemia|
|Study Website:||View Trial Website|
- I. To identify the maximum-tolerated dose (MTD) of ruxolitinib in combination with liposome-encapsulated daunorubicin-cytarabine (CPX-351).
- II. To evaluate the objective response rate in participants with post-myeloproliferative neoplasm (MPN)- accelerated phase (AP)/blast phase (BP) following treatment with the combination of ruxolitinib and CPX-351 (per 2012 MPN-BP criteria).
- I. To evaluate the safety and tolerability of ruxolitinib in combination with CPX-351.
- II. Assess survival outcomes and proportion of patients receiving transplant associated with ruxolitinib in combination with CPX-351.
- I. To evaluate the rate of response among participants with MPN-AP/BP using European Leukemia Net (ELN) criteria.
- II. Assess the proportion of treated participants with minimal residual disease.
Experimental: Treatment (CPX-351, ruxolitinib, allogeneic SCT)
See Detailed Description.
Procedure: - Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allogeneic SCT
Drug: - Liposome-encapsulated Daunorubicin-Cytarabine
Drug: - Ruxolitinib
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.