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New treatment option for Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Official title Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT03874052
What this study is testing
What is Azacitidine?
Azacitidine is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for acute myeloid leukemia arising from previous myelodysplastic syndrome.
Also referred to as 5 AZC, 5-AC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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...
- Therapy with a biologic investigational or non-investigational agent (e.g., monoclonal antibody) within 30 days of the planned start of study...
- Concurrent active malignancy with expected survival of less than 1 year, at the discretion of the investigator. For example, candidates with treated...
See the full eligibility criteria
Who can join
- 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...
- 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
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States; Portland, Oregon, United States; Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.