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Ruxolitinib Phosphate in Treating Older Patients with Acute Myeloid Leukemia in First Complete Remission after Donor Stem Cell Transplant

This phase II trial studies how well ruxolitinib phosphate works in treating older patients with acute myeloid leukemia in first complete remission after donor stem cell transplant. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Hematologic, Leukemia
Phase II
Adults
Mol. targeted/Immunotherapy/Biologics
Ruxolitinib
Byrne, Michael
National
Vanderbilt University
06-27-2018
Treatment
VICCBMT1778
NCT03286530

Eligibility

60 Years
BOTH
NO
Inclusion Criteria:

Participants must have pathologically confirmed acute myeloid leukemia (AML) in first complete remission (CR1) as defined by: * Bone marrow biopsy with = 1000/uL (achieved post-induction at some point) * Please note that full platelet recovery is not necessary, and thus, patients achieving pathological complete remission (CRp) are eligible

Participants must be designated to undergo reduced intensity allogeneic peripheral blood hematopoietic stem cell transplantation (HSCT); consent will be obtained prior to admission for HSCT; the following HSCT conditions must be planned: * Donors must be 8/8 HLA-matched (at the allele level) as defined by matching at HLA-A, -B, -DR and –C who pass institutional standard to serve as a peripheral blood stem cell donor * Donor grafts must be granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cells with dose and apheresis logistics at the discretion of institutional standard * Conditioning therapy will be one of the following 3 options: ** Fludarabine/melphalan where fludarabine is >= 90 mg/m^2 intravenously (IV) total dose and melphalan is 100-140 mg/m^2 IV total dose; exact logistics of administration are at the discretion of institutional standard ** Fludarabine/busulfan where fludarabine is >= 90 mg/m^2 IV total dose and busulfan = 6.4 mg/kg IV total dose; exact logistics of administration are at the discretion of institutional standard ** Fludarabine/busulfan where fludarabine is >= 90 mg/m^2 IV total dose and busulfan is dosed to achieve area under the curve (AUC) of 4000 umol/min based on a pharmacokinetics determined from a test dose; exact logistics are at the discretion of institutional standard * GVHD prophylaxis is comprised of tacrolimus/short course methotrexate as defined by tacrolimus started prior to day 0 of HSCT and methotrexate given after HSCT on days +1, +3 and +6 +/- +11 at a dose of 5-10 mg/m^2 IV; exact logistics are at the discretion of the treating institution

Eastern Cooperative Oncology Group (ECOG) performance status 0–2

Male participants must agree to use an acceptable method for contraception during the entire study treatment period and through 6 months after the last dose of treatment

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



Exclusion Criteria:

Have had a prior allogeneic HSCT

Platelet count of =
Hemoglobin of =
Absolute neutrophil count (ANC) of
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) and alkaline phosphatase >= 3 x institutional upper limit of normal (ULN)

Total bilirubin > 2.0 mg/dL

Adequate renal function as defined by calculated creatinine clearance =
Have a history of other malignancy(ies) unless: They have been disease-free for at least 5 years and are deemed by the treating investigator to be at low risk for recurrence of that malignancy, or the only cancer they have had is cervical cancer in situ, or basal cell or squamous cell carcinoma of the skin

Have a chronic or active infection that requires systemic antibiotics, antifungal or antiviral treatment

Have current or a history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, or any history of documented diastolic or systolic dysfunction (left ventricular ejection fraction [LVEF]
Have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Be human immunodeficiency virus (HIV)-positive

Have active uncontrolled infection; an active uncontrolled infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection; persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection

Planned use of ex vivo or in vivo T-cell depletion

Have current or a history of ventricular or life-threatening arrhythmias or diagnosis

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