Is participation in this Columbus clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Clinical Trial in Columbus, OH

Q: Is NCT03874052 recruiting in Columbus, OH?

Yes, NCT03874052 is currently recruiting participants at its Columbus, OH location. This acute myeloid leukemia arising from previous myelodysplastic syndrome clinical trial is actively enrolling qualified participants.

Q: How do I join the acute myeloid leukemia arising from previous myelodysplastic syndrome clinical trial in Columbus?

To join this clinical trial in Columbus, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Study in Columbus

This phase I trial studies the side effects and best dose of ruxolitinib when given together with venetoclax and compares the effect of ruxolitinib in combination with venetoclax to venetoclax and azacitidine in treating patients with acute myeloid leukemia (AML) that has come back (relapsed) or has not responded to treatment (refractory). Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Azacitidine stops cells from making deoxyribonucleic acid and may kill cancer cells. It is a type of antimetabolite. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving ruxolitinib in combination with venetoclax and azacitidine may be safe, tolerable, and/or effective compared to ruxolitinib with venetoclax in treating patients with relapsed or refractory AML.

Sponsor: Jennifer Saultz

Who Can Participate

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

Age \>= 18 years at time of informed consent. Persons of all genders and gender identities, and members of all races and ethnic groups will be included

Morphologically documented relapsed/refractory (R/R) AML or R/R secondary AML (sAML) that has progressed after at least 1 prior therapy for AML

Prior treatment with venetoclax and azacitidine is allowed

Treatment with hydroxyurea will not be considered a line of therapy

Patients with morphologically documented myelodysplastic syndrome (MDS) that has progressed on hypomethylating agent (HMA) therapy also will be considered if the patient is ineligible for induction with intensive chemotherapy (IC), defined for this study as meeting one or more of the following criteria:

Severe cardiac disorder (e.g., congestive heart failure requiring treatment, left ventricular ejection fraction (LVEF) of ≤ 50%, or chronic stable angina)

Severe pulmonary disorder, certified by the managing physician

Creatinine clearance of \< 45 ml/min or

Hepatic disorder with total bilirubin \> 1.5 x upper limit of normal (ULN)

Eastern Cooperative Oncology Group (ECOG) equal to 2

Other comorbidity(ies) judged to be incompatible with high dose chemotherapy by the managing physician will be considered, at the discretion of the principal investigator (PI)

ECOG performance status 0 to 2

Persons of childbearing potential (PCBP) must have a negative serum or urine pregnancy test within 14 days prior to start of study drug administration

Patients must agree to use an adequate method of contraception while on study treatment and for 120 days after the last dose of ruxolitinib for Arm 1 and 6 months after the last dose of azacitidine for Arm 2

Must be able to take and absorb oral medications

Creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hour urine collection

Total serum bilirubin ≤ 1.5 x ULN unless thought to be due to leukemic involvement

Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 3.0 x ULN unless thought to be due to leukemic involvement

Exclusion Criteria

Diagnosis of acute promyelocytic leukemia (APL or AML M3 subtype)

Active central nervous system involvement with AML

Chemotherapy or therapy with a non-investigational agent other than a biologic intended to within 1 week of the planned start of study therapy, with the exception of hydroxyurea for cytoreduction of proliferative disease, or at the discretion of the principal investigator (PI)

Therapy with a non-biologic investigational agent within 14 days or 5 half lives, whichever is longer, of the planned start of study therapy, or for the period recommended by the institution's research pharmacy service, or at the discretion of the PI

Therapy with a biologic investigational or non-investigational agent (e.g., monoclonal antibody) within 30 days of the planned start of study therapy, or for the period recommended by the institution's research pharmacy service, or at the discretion of the PI

Concurrent active malignancy with expected survival of less than 1 year, at the discretion of the investigator. For example, candidates with treated skin cancers, prostate cancer, breast cancer, etc. without metastatic disease are candidates for therapy since their expected survival exceeds that of relapsed or refractory AML

Clinically significant graft versus host disease (GVHD) or active GVHD requiring initiation or escalation of treatment within 28-day screening period

Participants with rapidly progressive disease (defined by blast count doubles within 48 hours) or organ dysfunction

Documented cardiac insufficiency (e.g., symptomatic heart failure, left ventricular ejection fraction of ≤ 40%)

Symptomatic shortness of breath or patient requires supplemental oxygen support

Clinically significant coagulation abnormality, such as disseminated intravascular coagulation

Known history of cerebrovascular accident, myocardial infarction, or intracranial hemorrhage within 2 months of enrollment

Known clinically significant liver disease defined as ongoing drug-induced liver injury, chronic active hepatitis C (hepatitis C virus \[HCV\]), chronic active hepatitis B (hepatitis B virus \[HBV\]), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, portal hypertension, or history of autoimmune hepatitis

Untreated HIV or active hepatitis C detectable by polymerase chain reaction (PCR), or chronic hepatitis B (patients positive for hepatitis B core antibody who are receiving intravenous immunoglobulin therapy \[IVIG\] are eligible if hepatitis B \[HepB\] PCR is negative)

Per PI discretion, active infection that is not well controlled by antibacterial or antiviral therapy \*Patients with a known history of tuberculosis (TB; Mycobacterium tuberculosis) are not eligible for participation. At investigator discretion, latent TB test should be performed for individuals considered to be at high-risk (e.g., immune compromised, persons that have traveled to, or emigrated from, regions with high rates of TB)

Clinically significant surgery within 2 weeks of enrollment

Unwillingness to receive infusion of blood products

Requires use of medications interact with study drug and that cannot be terminated or adjusted. Use of the following therapies requires review by the sponsor investigator:

Strong and moderate CYP3A inhibitors

Strong and Moderate CYP3A inducers

Patients with uncontrolled white blood cell (WBC) count (defined as \> 25 K/mm\^3 and not controlled with hydroxyurea)

Patients with known sensitivity to ruxolitinib, venetoclax, or azacitidine

Since it is unknown whether ruxolitinib, venetoclax, or azacitidine (or their metabolites) are excreted in human milk and because of the potential for serious adverse reactions in the nursing infant, breastfeeding concurrent with study participation is prohibited

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Columbus?

Yes, this clinical trial (NCT03874052) has an active research site in Columbus, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Treatment Options in Columbus, OH

If you're searching for acute myeloid leukemia arising from previous myelodysplastic syndrome treatment options in Columbus, OH, this clinical trial (NCT03874052) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Columbus research site is actively enrolling participants for this clinical trial. You'll receive care from experienced acute myeloid leukemia arising from previous myelodysplastic syndrome specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acute myeloid leukemia arising from previous myelodysplastic syndrome clinical trials near you to find additional studies recruiting in your area.

Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Clinical Trial in Columbus, OH

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